Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer

Purpose

This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.

Conditions

  • Castration Levels of Testosterone
  • Metastatic Prostatic Adenocarcinoma
  • Stage IV Prostate Cancer AJCC v8
  • Stage IVA Prostate Cancer AJCC v8
  • Stage IVB Prostate Cancer AJCC v8

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Male
Accepts Healthy Volunteers
No

Criteria

Inclusion Criteria:

- STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: All patients must have a
histologically or cytologically proven diagnosis of adenocarcinoma of the prostate.
Patients with pure small cell carcinoma* (SCC), sarcomatoid, or squamous cell
carcinoma are not eligible. (*morphology must be consistent with SCC; synaptophysin
or chromogranin positive by immunohistochemical staining is insufficient to diagnose
SCC).

- STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients must have an intact
prostate. No prior local therapy for prostate adenocarcinoma is allowed (e.g.,
brachytherapy, high-intensity focused ultrasound [HIFU], cryotherapy, laser ablative
therapies). Any prior therapy for benign conditions, such as obstruction, are
acceptable (e.g., transurethral resection of the prostate, greenlight laser
ablation, microwave ablation).

- STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients must have evidence of
metastatic disease on technetium bone scan and computed tomography (CT) or magnetic
resonance imaging (MRI) within 42 days prior to starting standard systemic therapy.
Metastatic disease that is detected by positron emission tomography (PET) scan only
(sodium fluoride [NaF], prostate-specific membrane antigen [PSMA],
anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic acid [FACBC], carbon [C]11) but
not conventional imaging (technetium [Tc]99 bone scan, CT or MRI) or solitary
metastases by conventional imaging, must be confirmed histologically or
cytologically.

- STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients with known brain metastases
are not eligible. Brain imaging studies are not required for eligibility if the
patient has no neurologic signs or symptoms suggestive of brain metastasis. If brain
imaging studies are performed, they must be negative for disease.

- STEP 1 REGISTRATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must have received
no more than 28 weeks of standard systemic therapy (SST). SST is defined as current
National Comprehensive Cancer Network (NCCN) guidelines for metastatic prostate
cancer.

- STEP 1 REGISTRATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must not have
progressed while on SST.

- STEP 1 REGISTRATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients with
oligometastatic prostate cancer may receive metastasis directed therapy to up to
four sites of disease prior to randomization.

- STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: Patients must have a complete
physical examination and medical history within 28 days prior to registration.

- STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: Patients must have a PSA
documented prior to initiation of SST and within 28 days prior to registration. Any
additional PSAs measured while receiving SST should be recorded.

- STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: Patients must have a testosterone
lab documented within 28 days prior to randomization. Any additional testosterone
labs measured while receiving SST should be recorded as well as pretreatment
initiation if available.

- STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: No other prior malignancy is
allowed except for the following: adequately treated basal cell or squamous cell
skin cancer, adequately treated stage 0, I or II cancer from which the patient is
currently in complete remission, or any other cancer from which the patient has been
disease free for three years.

- STEP 1 REGISTRATION: SPECIMEN SUBMISSION CRITERIA: Patients must be offered the
opportunity to participate in translational medicine studies and specimen banking
for future studies.

- STEP 1 REGISTRATION: QUALITY OF LIFE CRITERIA: Patients who can complete
Patient-Reported Outcome instruments in English, Spanish or French, must participate
in the quality of life studies.

- STEP 1 REGISTRATION: REGULATORY CRITERIA: Patients must be informed of the
investigational nature of this study and must sign and give written informed consent
in accordance with institutional and federal guidelines.

- STEP 2 RANDOMIZATION: DISEASE-RELATED CRITERIA: As a part of the OPEN registration
process the treating institution's identity is provided in order to ensure that the
current (within 365 days) date of institutional review board approval for this study
has been entered in the system.

- STEP 2 RANDOMIZATION: DISEASE-RELATED CRITERIA: Patients must have no evidence of
disease progression during the 28 weeks of SST by PSA measure, bone scan and CT or
MRI or symptomatic deterioration (as defined by physician discretion) within 28 days
prior to randomization.

- STEP 2 RANDOMIZATION: DISEASE-RELATED CRITERIA: Patients must have consultation with
a urologist and have surgically resectable disease regardless of definitive
treatment intent or randomization.

- STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must have received
between 22 and 28 weeks of SST as measured from the date of first hormonal therapy
or surgical castration. SST is defined by current NCCN guidelines for metastatic
prostate cancer.

- STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must not be
planning to receive docetaxel after randomization.

- STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Any toxicities from SST
must have resolved to =< grade 1 (Common Terminology Criteria for Adverse Events
[CTCAE] version 5.0) prior to randomization.

- STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients may have received
elective metastasis directed therapy to oligometastatic sites (=< 4 sites). All
treatment must be completed prior to randomization.

- STEP 2 RANDOMIZATION: CLINICAL/LABORATORY CRITERIA: Patients must have a PSA
performed within 28 days prior to randomization.

- STEP 2 RANDOMIZATION: CLINICAL/LABORATORY CRITERIA: Patients must have a
testosterone < 50 ng/dL within 28 days prior to randomization.

- STEP 2 RANDOMIZATION: CLINICAL/LABORATORY CRITERIA: Patients must have a Zubrod
performance status of 0 ? 1 within 28 days prior to randomization.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Arm I (SST) 		Participants receive 1 acceptable form of SST as in Induction except for treatment with docetaxel and prednisone.
  • Drug: Abiraterone
    Given PO
    Other names:
    • CB 7598
  • Drug: Bicalutamide
    Given PO
    Other names:
    • Casodex
    • Cosudex
    • ICI 176,334
    • ICI 176334
  • Drug: Degarelix
    Given via injection
    Other names:
    • FE200486
    • Firmagon
  • Drug: Flutamide
    Given PO
    Other names:
    • 4'-Nitro-3'-trifluoromethylisobutyranilide
    • Apimid
    • Cebatrol
    • Chimax
    • Cytomid
    • Drogenil
    • Euflex
    • Eulexine
    • Flucinom
    • Flucinome
    • Flugerel
    • Fluken
    • Flulem
    • FLUT
    • Fluta-Gry
    • Flutabene
    • Flutacan
    • Flutamex
    • Flutamin
    • Flutan
    • Flutaplex
    • Fugerel
    • Grisetin
    • Niftolide
    • Oncosal
    • Profamid
    • Propanamide, 2-Methyl-N-(4-nitro-3-(trifluoromethyl)phenyl)-
    • Prostacur
    • Prostadirex
    • Prostica
    • Prostogenat
    • SCH 13521
    • Tafenil
    • Tecnoflut
    • Testotard
  • Drug: Goserelin Acetate
    Given SC
    Other names:
    • ZDX
    • Zoladex
  • Drug: Histrelin Acetate
    Receive SC
    Other names:
    • Supprelin
    • Vantas
  • Drug: Leuprolide Acetate
    Receive SC or IM
    Other names:
    • A-43818
    • Abbott 43818
    • Abbott-43818
    • Carcinil
    • Depo-Eligard
    • Eligard
    • Enanton
    • Enantone
    • Enantone-Gyn
    • Ginecrin
    • LEUP
    • Leuplin
    • Leuprorelin Acetate
    • Lucrin
    • Lucrin Depot
    • Lupron
    • Lupron Depot
    • Lupron Depot-3 Month
    • Lupron Depot-4 Month
    • Lupron Depot-Ped
    • Procren
    • Procrin
    • Prostap
    • TAP-144
    • Trenantone
    • Uno-Enantone
    • Viadur
  • Drug: Nilutamide
    Given PO
    Other names:
    • Anandron
    • Nilandron
    • RU-23908
  • Procedure: Orchiectomy
    Undergo bilateral orchiectomy
    Other names:
    • Castration
    • Male Castration
    • Male Gonadectomy
    • orchidectomy
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Drug: Triptorelin
    injection
    Other names:
    • 6-D-Tryptophan-LH-RH
    • 6-D-Tryptophanluteinizing Hormone-releasing Factor
    • AY-25650
    • CL-118,532
    • Decapeptyl
    • Detryptoreline
Experimental
Arm II (SST, prostatectomy or radiation therapy) 		Participants receive 1 acceptable form of SST as in Induction except for treatment with docetaxel and prednisone. Participants undergo prostatectomy within 8 weeks after randomization or radiation therapy within 4 weeks of randomization.
  • Drug: Abiraterone
    Given PO
    Other names:
    • CB 7598
  • Drug: Bicalutamide
    Given PO
    Other names:
    • Casodex
    • Cosudex
    • ICI 176,334
    • ICI 176334
  • Drug: Degarelix
    Given via injection
    Other names:
    • FE200486
    • Firmagon
  • Drug: Flutamide
    Given PO
    Other names:
    • 4'-Nitro-3'-trifluoromethylisobutyranilide
    • Apimid
    • Cebatrol
    • Chimax
    • Cytomid
    • Drogenil
    • Euflex
    • Eulexine
    • Flucinom
    • Flucinome
    • Flugerel
    • Fluken
    • Flulem
    • FLUT
    • Fluta-Gry
    • Flutabene
    • Flutacan
    • Flutamex
    • Flutamin
    • Flutan
    • Flutaplex
    • Fugerel
    • Grisetin
    • Niftolide
    • Oncosal
    • Profamid
    • Propanamide, 2-Methyl-N-(4-nitro-3-(trifluoromethyl)phenyl)-
    • Prostacur
    • Prostadirex
    • Prostica
    • Prostogenat
    • SCH 13521
    • Tafenil
    • Tecnoflut
    • Testotard
  • Drug: Goserelin Acetate
    Given SC
    Other names:
    • ZDX
    • Zoladex
  • Drug: Histrelin Acetate
    Receive SC
    Other names:
    • Supprelin
    • Vantas
  • Drug: Leuprolide Acetate
    Receive SC or IM
    Other names:
    • A-43818
    • Abbott 43818
    • Abbott-43818
    • Carcinil
    • Depo-Eligard
    • Eligard
    • Enanton
    • Enantone
    • Enantone-Gyn
    • Ginecrin
    • LEUP
    • Leuplin
    • Leuprorelin Acetate
    • Lucrin
    • Lucrin Depot
    • Lupron
    • Lupron Depot
    • Lupron Depot-3 Month
    • Lupron Depot-4 Month
    • Lupron Depot-Ped
    • Procren
    • Procrin
    • Prostap
    • TAP-144
    • Trenantone
    • Uno-Enantone
    • Viadur
  • Drug: Nilutamide
    Given PO
    Other names:
    • Anandron
    • Nilandron
    • RU-23908
  • Procedure: Orchiectomy
    Undergo bilateral orchiectomy
    Other names:
    • Castration
    • Male Castration
    • Male Gonadectomy
    • orchidectomy
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Radiation: Radiation Therapy
    Standard radiation
    Other names:
    • Cancer Radiotherapy
    • Irradiate
    • Irradiated
    • irradiation
    • Radiation
    • Radiotherapeutics
    • RADIOTHERAPY
    • RT
    • Therapy, Radiation
  • Procedure: Radical Prostatectomy
    Standard surgery
    Other names:
    • Prostatovesiculectomy
  • Drug: Triptorelin
    injection
    Other names:
    • 6-D-Tryptophan-LH-RH
    • 6-D-Tryptophanluteinizing Hormone-releasing Factor
    • AY-25650
    • CL-118,532
    • Decapeptyl
    • Detryptoreline
Active Comparator
Step 1 (pre-randomization) 		Standard treatment data collection prior to randomization
  • Drug: Abiraterone
    Given PO
    Other names:
    • CB 7598
  • Drug: Bicalutamide
    Given PO
    Other names:
    • Casodex
    • Cosudex
    • ICI 176,334
    • ICI 176334
  • Drug: Degarelix
    Given via injection
    Other names:
    • FE200486
    • Firmagon
  • Drug: Docetaxel
    intravenous
    Other names:
    • Docecad
    • RP56976
    • Taxotere
    • Taxotere Injection Concentrate
  • Drug: Flutamide
    Given PO
    Other names:
    • 4'-Nitro-3'-trifluoromethylisobutyranilide
    • Apimid
    • Cebatrol
    • Chimax
    • Cytomid
    • Drogenil
    • Euflex
    • Eulexine
    • Flucinom
    • Flucinome
    • Flugerel
    • Fluken
    • Flulem
    • FLUT
    • Fluta-Gry
    • Flutabene
    • Flutacan
    • Flutamex
    • Flutamin
    • Flutan
    • Flutaplex
    • Fugerel
    • Grisetin
    • Niftolide
    • Oncosal
    • Profamid
    • Propanamide, 2-Methyl-N-(4-nitro-3-(trifluoromethyl)phenyl)-
    • Prostacur
    • Prostadirex
    • Prostica
    • Prostogenat
    • SCH 13521
    • Tafenil
    • Tecnoflut
    • Testotard
  • Drug: Goserelin Acetate
    Given SC
    Other names:
    • ZDX
    • Zoladex
  • Drug: Histrelin Acetate
    Receive SC
    Other names:
    • Supprelin
    • Vantas
  • Drug: Leuprolide Acetate
    Receive SC or IM
    Other names:
    • A-43818
    • Abbott 43818
    • Abbott-43818
    • Carcinil
    • Depo-Eligard
    • Eligard
    • Enanton
    • Enantone
    • Enantone-Gyn
    • Ginecrin
    • LEUP
    • Leuplin
    • Leuprorelin Acetate
    • Lucrin
    • Lucrin Depot
    • Lupron
    • Lupron Depot
    • Lupron Depot-3 Month
    • Lupron Depot-4 Month
    • Lupron Depot-Ped
    • Procren
    • Procrin
    • Prostap
    • TAP-144
    • Trenantone
    • Uno-Enantone
    • Viadur
  • Drug: Nilutamide
    Given PO
    Other names:
    • Anandron
    • Nilandron
    • RU-23908
  • Procedure: Orchiectomy
    Undergo bilateral orchiectomy
    Other names:
    • Castration
    • Male Castration
    • Male Gonadectomy
    • orchidectomy
  • Drug: Prednisone
    Given PO
    Other names:
    • .delta.1-Cortisone
    • 1, 2-Dehydrocortisone
    • Adasone
    • Cortancyl
    • Dacortin
    • DeCortin
    • Decortisyl
    • Decorton
    • Delta 1-Cortisone
    • Delta-Dome
    • Deltacortene
    • Deltacortisone
    • Deltadehydrocortisone
    • Deltasone
    • Deltison
    • Deltra
    • Econosone
    • Lisacort
    • Meprosona-F
    • Metacortandracin
    • Meticorten
    • Ofisolona
    • Orasone
    • Panafcort
    • Panasol-S
    • Paracort
    • PRED
    • Predicor
    • Predicorten
    • Prednicen-M
    • Prednicort
    • Prednidib
    • Prednilonga
    • Predniment
    • Prednisonum
    • Prednitone
    • Promifen
    • Servisone
    • SK-Prednisone
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Drug: Triptorelin
    injection
    Other names:
    • 6-D-Tryptophan-LH-RH
    • 6-D-Tryptophanluteinizing Hormone-releasing Factor
    • AY-25650
    • CL-118,532
    • Decapeptyl
    • Detryptoreline

Recruiting Locations

Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
Contact:
Site Public Contact
602-747-9738

Cancer Center at Saint Joseph's
Phoenix, Arizona 85004
Contact:
Site Public Contact
602-406-0777
CancerInstitute@DignityHealth.org

University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona 85704
Contact:
Site Public Contact
520-694-8900

University of Arizona Cancer Center-North Campus
Tucson, Arizona 85719
Contact:
Site Public Contact
UACC-IIT@uacc.arizona.edu

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Site Public Contact
501-686-8274

Kaiser Permanente-Deer Valley Medical Center
Antioch, California 94531
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Community Cancer Institute
Clovis, California 93611
Contact:
Site Public Contact
559-387-1827

City of Hope Comprehensive Cancer Center
Duarte, California 91010
Contact:
Site Public Contact
800-826-4673
becomingapatient@coh.org

Kaiser Permanente Dublin
Dublin, California 94568
Contact:
Site Public Contact
877-642-4691

Kaiser Permanente-Fremont
Fremont, California 94538
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Fresno Cancer Center
Fresno, California 93720
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-Fresno
Fresno, California 93720
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

UC San Diego Moores Cancer Center
La Jolla, California 92093
Contact:
Site Public Contact
858-822-5354
cancercto@ucsd.edu

Tibor Rubin VA Medical Center
Long Beach, California 90822
Contact:
Site Public Contact
562-826-8000

Los Angeles County-USC Medical Center
Los Angeles, California 90033
Contact:
Site Public Contact
323-865-0451

USC / Norris Comprehensive Cancer Center
Los Angeles, California 90033
Contact:
Site Public Contact
323-865-0451

Fremont - Rideout Cancer Center
Marysville, California 95901
Contact:
Site Public Contact
530-749-4400

Kaiser Permanente-Modesto
Modesto, California 95356
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente Oakland-Broadway
Oakland, California 94611
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Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-Oakland
Oakland, California 94611
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Desert Regional Medical Center
Palm Springs, California 92262
Contact:
Site Public Contact
760-416-4730

Stanford Cancer Institute Palo Alto
Palo Alto, California 94304
Contact:
Site Public Contact
650-498-7061
ccto-office@stanford.edu

Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California 95670
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877-642-4691
Kpoct@kp.org

Kaiser Permanente-Redwood City
Redwood City, California 94063
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877-642-4691
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Kaiser Permanente-Richmond
Richmond, California 94801
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877-642-4691
Kpoct@kp.org

Rohnert Park Cancer Center
Rohnert Park, California 94928
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877-642-4691
Kpoct@kp.org

Kaiser Permanente-Roseville
Roseville, California 95661
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877-642-4691
Kpoct@kp.org

The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California 95678
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877-642-4691
Kpoct@kp.org

Kaiser Permanente Downtown Commons
Sacramento, California 95814
Contact:
Site Public Contact
877-642-4691
kpoct@kp.org

Mercy Cancer Center - Sacramento
Sacramento, California 95816
Contact:
Site Public Contact
916-556-3301
OncologyResearch@DignityHealth.org

University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
Contact:
Site Public Contact
916-734-3089

Kaiser Permanente-South Sacramento
Sacramento, California 95823
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877-642-4691
Kpoct@kp.org

South Sacramento Cancer Center
Sacramento, California 95823
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877-642-4691
Kpoct@kp.org

Kaiser Permanente-San Francisco
San Francisco, California 94115
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877-642-4691
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Kaiser Permanente-Santa Teresa-San Jose
San Jose, California 95119
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877-642-4691
Kpoct@kp.org

Kaiser Permanente San Leandro
San Leandro, California 94577
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877-642-4691
Kpoct@kp.org

Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California 93401
Contact:
Site Public Contact
805-219-4673
ResearchInstituteInquiries@CommonSpirit.org

Kaiser San Rafael-Gallinas
San Rafael, California 94903
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877-642-4691
Kpoct@kp.org

Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California 95051
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877-642-4691
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Kaiser Permanente-Santa Rosa
Santa Rosa, California 95403
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877-642-4691
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Kaiser Permanente Cancer Treatment Center
South San Francisco, California 94080
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877-642-4691
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Kaiser Permanente-South San Francisco
South San Francisco, California 94080
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877-642-4691
Kpoct@kp.org

Kaiser Permanente-Stockton
Stockton, California 95210
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California 96161
Contact:
Site Public Contact
530-582-6450

Kaiser Permanente Medical Center-Vacaville
Vacaville, California 95688
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-Vallejo
Vallejo, California 94589
Contact:
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877-642-4691
Kpoct@kp.org

Kaiser Permanente-Walnut Creek
Walnut Creek, California 94596
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

University of Colorado Hospital
Aurora, Colorado 80045
Contact:
Site Public Contact
720-848-0650

Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado 80304
Contact:
Site Public Contact
303-777-2663
info@westernstatesncorp.org

UCHealth Memorial Hospital Central
Colorado Springs, Colorado 80909
Contact:
Site Public Contact
719-365-2406

Memorial Hospital North
Colorado Springs, Colorado 80920
Contact:
Site Public Contact
719-364-6700

Porter Adventist Hospital
Denver, Colorado 80210
Contact:
Site Public Contact
719-776-6550
ResearchTracking@Centura.Org

Shaw Cancer Center
Edwards, Colorado 81632
Contact:
Site Public Contact
970-569-7429

Poudre Valley Hospital
Fort Collins, Colorado 80524
Contact:
Site Public Contact
970-297-6150

North Colorado Medical Center
Greeley, Colorado 80631
Contact:
Site Public Contact
970-810-3046
BMDACCResearchCOMailbox@bannerhealth.com

Littleton Adventist Hospital
Littleton, Colorado 80122
Contact:
Site Public Contact
719-776-6550
ResearchTracking@Centura.Org

McKee Medical Center
Loveland, Colorado 80539
Contact:
Site Public Contact
970-810-3046
BMDACCResearchCOMailbox@bannerhealth.com

Parker Adventist Hospital
Parker, Colorado 80138
Contact:
Site Public Contact
719-776-6550
ResearchTracking@Centura.Org

Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut 06437
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Yale University
New Haven, Connecticut 06520
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Stamford Hospital/Bennett Cancer Center
Stamford, Connecticut 06904
Contact:
Site Public Contact
203-323-8944

Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut 06611
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut 06385
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Veterans Affairs Connecticut Healthcare System-West Haven Campus
West Haven, Connecticut 06516
Contact:
Site Public Contact
203-937-3421

Helen F Graham Cancer Center
Newark, Delaware 19713
Contact:
Site Public Contact
302-623-4450
lbarone@christianacare.org

Christiana Care Health System-Christiana Hospital
Newark, Delaware 19718
Contact:
Site Public Contact
302-623-4450
lbarone@christianacare.org

George Washington University Medical Center
Washington, District of Columbia 20037
Contact:
Site Public Contact
202-741-2981

Mount Sinai Comprehensive Cancer Center at Aventura
Aventura, Florida 33180
Contact:
Site Public Contact
305-674-2625
yenrique@msmc.com

UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida 33146
Contact:
Site Public Contact
305-243-2647

UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida 33442
Contact:
Site Public Contact
305-243-2647

Baptist MD Anderson Cancer Center
Jacksonville, Florida 32207
Contact:
Site Public Contact
904-202-7468

Mount Sinai Medical Center
Miami Beach, Florida 33140
Contact:
Site Public Contact
305-674-2625
yenrique@msmc.com

University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida 33136
Contact:
Site Public Contact
305-243-2647

UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida 33176
Contact:
Site Public Contact
305-243-2647

UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida 33324
Contact:
Site Public Contact
305-243-2647

Grady Health System
Atlanta, Georgia 30303
Contact:
Site Public Contact
404-489-9164

Emory University Hospital Midtown
Atlanta, Georgia 30308
Contact:
Site Public Contact
888-946-7447

Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
Contact:
Site Public Contact
404-778-1868

Emory Saint Joseph's Hospital
Atlanta, Georgia 30342
Contact:
Site Public Contact
404-851-7115

Augusta University Medical Center
Augusta, Georgia 30912
Contact:
Site Public Contact
706-721-2388
ga_cares@augusta.edu

Atlanta VA Medical Center
Decatur, Georgia 30033
Contact:
Site Public Contact
404-321-6111

Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho 83605
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho 83687
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Rush - Copley Medical Center
Aurora, Illinois 60504
Contact:
Site Public Contact
630-978-6212
Cancer.Research@rushcopley.com

Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Canton
Canton, Illinois 61520
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Carthage
Carthage, Illinois 62321
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Rush University Medical Center
Chicago, Illinois 60612
Contact:
Site Public Contact
312-942-5498
clinical_trials@rush.edu

University of Illinois
Chicago, Illinois 60612
Contact:
Site Public Contact
312-355-3046

Decatur Memorial Hospital
Decatur, Illinois 62526
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Crossroads Cancer Center
Effingham, Illinois 62401
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Illinois CancerCare-Eureka
Eureka, Illinois 61530
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Macomb
Macomb, Illinois 61455
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Loyola University Medical Center
Maywood, Illinois 60153
Contact:
Site Public Contact
708-226-4357

Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Pekin
Pekin, Illinois 61554
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Peoria
Peoria, Illinois 61615
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Methodist Medical Center of Illinois
Peoria, Illinois 61636
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

OSF Saint Francis Medical Center
Peoria, Illinois 61637
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Peru
Peru, Illinois 61354
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Princeton
Princeton, Illinois 61356
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Carle Cancer Center
Urbana, Illinois 61801
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Reid Health
Richmond, Indiana 47374
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

McFarland Clinic - Ames
Ames, Iowa 50010
Contact:
Site Public Contact
515-239-4734
ksoder@mcfarlandclinic.com

Iowa Methodist Medical Center
Des Moines, Iowa 50309
Contact:
Site Public Contact
515-241-6727

University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa 52242
Contact:
Site Public Contact
800-237-1225

University of Kansas Cancer Center
Kansas City, Kansas 66160
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

Olathe Health Cancer Center
Olathe, Kansas 66061
Contact:
Site Public Contact
913-355-8000
Jeni.wakefield@olathehealth.org

University of Kansas Cancer Center-Overland Park
Overland Park, Kansas 66210
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas 66205
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky 40504
Contact:
Site Public Contact
859-629-7169
ResearchInstituteInquiries@CommonSpirit.org

Saint Joseph Hospital East
Lexington, Kentucky 40509
Contact:
Site Public Contact
859-629-7169
ResearchInstituteInquiries@CommonSpirit.org

The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky 40202
Contact:
Site Public Contact
502-562-3429

East Jefferson General Hospital
Metairie, Louisiana 70006
Contact:
Site Public Contact
504-210-3539
emede1@lsuhsc.edu

LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie, Louisiana 70006
Contact:
Site Public Contact
504-210-3539
emede1@lsuhsc.edu

MaineHealth Coastal Cancer Treatment Center
Bath, Maine 04530
Contact:
Site Public Contact
888-823-5923
ctsucontact@westat.com

Lafayette Family Cancer Center-EMMC
Brewer, Maine 04412
Contact:
Site Public Contact
800-987-3005

Maine Medical Center-Bramhall Campus
Portland, Maine 04102
Contact:
Site Public Contact
207-885-7565

MaineHealth Cancer Care Center of York County
Sanford, Maine 04073
Contact:
Site Public Contact
207-459-1600

MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
Sanford, Maine 04073
Contact:
Site Public Contact
LLemire@mmc.org

Maine Medical Center- Scarborough Campus
Scarborough, Maine 04074
Contact:
Site Public Contact
207-396-8090
wrighd@mmc.org

Saint Joseph Mercy Hospital
Ann Arbor, Michigan 48106
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan 48109
Contact:
Site Public Contact
800-865-1125

Saint Joseph Mercy Brighton
Brighton, Michigan 48114
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Henry Ford Cancer Institute-Downriver
Brownstown, Michigan 48183
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

Saint Joseph Mercy Canton
Canton, Michigan 48188
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Saint Joseph Mercy Chelsea
Chelsea, Michigan 48118
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

GenesisCare USA - Clarkston
Clarkston, Michigan 48346
Contact:
Site Public Contact
941-833-5700
Rudi.Ross@usa.genesiscare.com

Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan 48038
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

Wayne State University/Karmanos Cancer Institute
Detroit, Michigan 48201
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

Henry Ford Hospital
Detroit, Michigan 48202
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

GenesisCare USA - Farmington Hills
Farmington Hills, Michigan 48334
Contact:
Site Public Contact
941-833-5700
Rudi.Ross@usa.genesiscare.com

Spectrum Health at Butterworth Campus
Grand Rapids, Michigan 49503
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

West Michigan Cancer Center
Kalamazoo, Michigan 49007
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Sparrow Hospital
Lansing, Michigan 48912
Contact:
Site Public Contact
517-364-9400

GenesisCare USA - Macomb
Macomb, Michigan 48044
Contact:
Site Public Contact
941-833-5700
Rudi.Ross@usa.genesiscare.com

GenesisCare USA - Madison Heights
Madison Heights, Michigan 48071
Contact:
Site Public Contact
941-833-5700
Rudi.Ross@usa.genesiscare.com

21st Century Oncology-Pontiac
Pontiac, Michigan 48341
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Ascension Saint Mary's Hospital
Saginaw, Michigan 48601
Contact:
Site Public Contact
989-907-8411
lori.srebinski@ascension.org

Munson Medical Center
Traverse City, Michigan 49684
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

GenesisCare USA - Troy
Troy, Michigan 48098
Contact:
Site Public Contact
941-833-5700
Rudi.Ross@usa.genesiscare.com

Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan 48322
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

Mercy Hospital
Coon Rapids, Minnesota 55433
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Fairview Southdale Hospital
Edina, Minnesota 55435
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Unity Hospital
Fridley, Minnesota 55432
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Hennepin County Medical Center
Minneapolis, Minnesota 55415
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Health Partners Inc
Minneapolis, Minnesota 55454
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

North Memorial Medical Health Center
Robbinsdale, Minnesota 55422
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota 55416
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Regions Hospital
Saint Paul, Minnesota 55101
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Saint Francis Regional Medical Center
Shakopee, Minnesota 55379
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Saint Francis Medical Center
Cape Girardeau, Missouri 63703
Contact:
Site Public Contact
573-334-2230
sfmc@sfmc.net

Southeast Cancer Center
Cape Girardeau, Missouri 63703
Contact:
Site Public Contact
573-651-5550

University of Missouri - Ellis Fischel
Columbia, Missouri 65212
Contact:
Site Public Contact
573-882-7440

Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri 63141
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Freeman Health System
Joplin, Missouri 64804
Contact:
Site Public Contact
417-347-4030
LJCrockett@freemanhealth.com

University of Kansas Cancer Center - North
Kansas City, Missouri 64154
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

Delbert Day Cancer Institute at PCRMC
Rolla, Missouri 65401
Contact:
Site Public Contact
573-458-7504
research@phelpshealth.org

Washington University School of Medicine
Saint Louis, Missouri 63110
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Siteman Cancer Center-South County
Saint Louis, Missouri 63129
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Missouri Baptist Medical Center
Saint Louis, Missouri 63131
Contact:
Site Public Contact
314-996-5569

Siteman Cancer Center at Christian Hospital
Saint Louis, Missouri 63136
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
Contact:
Site Public Contact
314-251-7066

Siteman Cancer Center at Saint Peters Hospital
Saint Peters, Missouri 63376
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri 63670
Contact:
Site Public Contact
314-996-5569

Mercy Hospital Springfield
Springfield, Missouri 65804
Contact:
Site Public Contact
417-269-4520

CoxHealth South Hospital
Springfield, Missouri 65807
Contact:
Site Public Contact
417-269-4520

Billings Clinic Cancer Center
Billings, Montana 59101
Contact:
Site Public Contact
800-996-2663
research@billingsclinic.org

Bozeman Deaconess Hospital
Bozeman, Montana 59715
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Saint James Community Hospital and Cancer Treatment Center
Butte, Montana 59701
Contact:
Site Public Contact
406-723-2621

Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana 59405
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Kalispell Regional Medical Center
Kalispell, Montana 59901
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Nebraska Medicine-Bellevue
Bellevue, Nebraska 68123
Contact:
Site Public Contact
402-559-6941
unmcrsa@unmc.edu

Nebraska Methodist Hospital
Omaha, Nebraska 68114
Contact:
Site Public Contact
402-354-5144

Nebraska Medicine-Village Pointe
Omaha, Nebraska 68118
Contact:
Site Public Contact
402-559-5600

University of Nebraska Medical Center
Omaha, Nebraska 68198
Contact:
Site Public Contact
402-559-6941
unmcrsa@unmc.edu

Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada 89052
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada 89106
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada 89128
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada 89144
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89148
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada 89169
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire 03301
Contact:
Site Public Contact
603-224-2556

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire 03756
Contact:
Site Public Contact
800-639-6918
cancer.research.nurse@dartmouth.edu

Solinsky Center for Cancer Care
Manchester, New Hampshire 03103
Contact:
Site Public Contact
800-339-6484

Hackensack University Medical Center
Hackensack, New Jersey 07601
Contact:
Site Public Contact
201-996-2879

Albany Medical Center
Albany, New York 12208
Contact:
Site Public Contact
518-262-5513

Montefiore Medical Center-Einstein Campus
Bronx, New York 10461
Contact:
Site Public Contact
718-379-6866
eskwak@montefiore.org

Montefiore Medical Center - Moses Campus
Bronx, New York 10467
Contact:
Site Public Contact
718-379-6866
eskwak@montefiore.org

Roswell Park Cancer Institute
Buffalo, New York 14263
Contact:
Site Public Contact
800-767-9355
askroswell@roswellpark.org

Noyes Memorial Hospital/Myers Cancer Center
Dansville, New York 14437
Contact:
Site Public Contact
WCICTOresearch@urmc.rochester.edu

Glens Falls Hospital
Glens Falls, New York 12801
Contact:
Site Public Contact
518-926-6700

NYP/Weill Cornell Medical Center
New York, New York 10065
Contact:
Site Public Contact
212-746-1848

Upstate Cancer Center Radiation Oncology at Oneida
Oneida, New York 13421
Contact:
Site Public Contact
315-464-3603
BinghamE@upstate.edu

Upstate Cancer Center Radiation Oncology at Oswego
Oswego, New York 13126
Contact:
Site Public Contact
315-464-3603
BinghamE@upstate.edu

Highland Hospital
Rochester, New York 14620
Contact:
Site Public Contact
585-341-8113

University of Rochester
Rochester, New York 14642
Contact:
Site Public Contact
585-275-5830

Stony Brook University Medical Center
Stony Brook, New York 11794
Contact:
Site Public Contact
800-862-2215

State University of New York Upstate Medical University
Syracuse, New York 13210
Contact:
Site Public Contact
315-464-5476

Atrium Health Stanly/LCI-Albemarle
Albemarle, North Carolina 28002
Contact:
Site Public Contact
800-804-9376

Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina 28203
Contact:
Site Public Contact
800-804-9376

Atrium Health Pineville/LCI-Pineville
Charlotte, North Carolina 28210
Contact:
Site Public Contact
980-442-2000

Atrium Health University City/LCI-University
Charlotte, North Carolina 28262
Contact:
Site Public Contact
800-804-9376

Levine Cancer Institute-Ballantyne
Charlotte, North Carolina 28277
Contact:
Site Public Contact
800-804-9376

Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina 28025
Contact:
Site Public Contact
800-804-9376

Levine Cancer Institute-Gaston
Gastonia, North Carolina 28054
Contact:
Site Public Contact
800-804-9376

Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina 28791
Contact:
Site Public Contact
828-696-4716
pardeecancerresearch@unchealth.unc.edu

Atrium Health Union/LCI-Union
Monroe, North Carolina 28112
Contact:
Site Public Contact
980-442-2000

CarolinaEast Medical Center
New Bern, North Carolina 28561
Contact:
Site Public Contact
252-634-6589
lharrison@carolinaeasthealth.com

Cleveland Clinic Mercy Hospital
Canton, Ohio 44708
Contact:
Site Public Contact
888-293-4673

Miami Valley Hospital South
Centerville, Ohio 45459
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio 45219
Contact:
Site Public Contact
513-584-7698
cancer@uchealth.com

MetroHealth Medical Center
Cleveland, Ohio 44109
Contact:
Site Public Contact
216-778-8526
dstrater@metrohealth.org

Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
Contact:
Site Public Contact
800-293-5066
Jamesline@osumc.edu

Miami Valley Hospital North
Dayton, Ohio 45415
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Greater Dayton Cancer Center
Kettering, Ohio 45409
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Kettering Medical Center
Kettering, Ohio 45429
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

ProMedica Flower Hospital
Sylvania, Ohio 43560
Contact:
Site Public Contact
419-824-1842
PCIOncResearch@promedica.org

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio 43606
Contact:
Site Public Contact
419-824-1842
PCIOncResearch@promedica.org

University of Cincinnati Cancer Center-West Chester
West Chester, Ohio 45069
Contact:
Site Public Contact
513-584-7698
cancer@uchealth.com

University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Contact:
Site Public Contact
405-271-8777
ou-clinical-trials@ouhsc.edu

Chambersburg Hospital
Chambersburg, Pennsylvania 17201
Contact:
Site Public Contact
888-823-5923
ctsucontact@westat.com

Geisinger Medical Center
Danville, Pennsylvania 17822
Contact:
Site Public Contact
570-271-5251
HemonCCTrials@geisinger.edu

Ephrata Cancer Center
Ephrata, Pennsylvania 17522
Contact:
Site Public Contact
717-721-4840

Adams Cancer Center
Gettysburg, Pennsylvania 17325
Contact:
Site Public Contact
877-441-7957

Sechler Family Cancer Center
Lebanon, Pennsylvania 17042
Contact:
Site Public Contact
717-741-8303
doxenberg@wellspan.org

Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania 17837
Contact:
Site Public Contact
570-374-8555
HemonCCTrials@geisinger.edu

University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania 15232
Contact:
Site Public Contact
412-647-8073

UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania 15232
Contact:
Site Public Contact
412-621-2334

Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania 18711
Contact:
Site Public Contact
570-271-5251
HemonCCTrials@geisinger.edu

WellSpan Health-York Cancer Center
York, Pennsylvania 17403
Contact:
Site Public Contact
877-441-7957

Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina 29316
Contact:
Site Public Contact
864-241-6251

Medical University of South Carolina
Charleston, South Carolina 29425
Contact:
Site Public Contact
843-792-9321
hcc-clinical-trials@musc.edu

Prisma Health Cancer Institute - Faris
Greenville, South Carolina 29605
Contact:
Site Public Contact
864-241-6251

Saint Francis Cancer Center
Greenville, South Carolina 29607
Contact:
Site Public Contact
864-603-6213
melissa_beckman@bshsi.org

Prisma Health Cancer Institute - Eastside
Greenville, South Carolina 29615
Contact:
Site Public Contact
864-241-6251

Prisma Health Cancer Institute - Greer
Greer, South Carolina 29650
Contact:
Site Public Contact
864-241-6251

Carolina Regional Cancer Center
Myrtle Beach, South Carolina 29577
Contact:
Site Public Contact
877-460-2657

Rock Hill Radiation Therapy Center
Rock Hill, South Carolina 29730
Contact:
Site Public Contact
800-804-9376

Levine Cancer Institute-Rock Hill
Rock Hill, South Carolina 29732
Contact:
Site Public Contact
800-804-9376

Prisma Health Cancer Institute - Seneca
Seneca, South Carolina 29672
Contact:
Site Public Contact
864-241-6251

Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
Contact:
Site Public Contact
800-811-8480

MD Anderson in The Woodlands
Conroe, Texas 77384
Contact:
Site Public Contact
866-632-6789
askmdanderson@mdanderson.org

Parkland Memorial Hospital
Dallas, Texas 75235
Contact:
Site Public Contact
214-590-5582
canceranswerline@UTSouthwestern.edu

UT Southwestern Simmons Cancer Center - RedBird
Dallas, Texas 75237
Contact:
Site Public Contact
214-648-7097
canceranswerline@utsouthwestern.edu

UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
Contact:
Site Public Contact
214-648-7097
canceranswerline@UTSouthwestern.edu

UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas 76104
Contact:
Site Public Contact
214-648-7097
canceranswerline@UTSouthwestern.edu

Lyndon Baines Johnson General Hospital
Houston, Texas 77026-1967
Contact:
Site Public Contact
713-566-5000

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas 77030
Contact:
Site Public Contact
713-798-1354
burton@bcm.edu

Ben Taub General Hospital
Houston, Texas 77030
Contact:
Site Public Contact
713-873-2000

M D Anderson Cancer Center
Houston, Texas 77030
Contact:
Site Public Contact
877-632-6789
askmdanderson@mdanderson.org

Michael E DeBakey VA Medical Center
Houston, Texas 77030
Contact:
Site Public Contact
800-553-2278

MD Anderson West Houston
Houston, Texas 77079
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877-632-6789
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MD Anderson League City
League City, Texas 77573
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877-632-6789
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UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas 75080
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972-669-7044
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Audie L Murphy VA Hospital
San Antonio, Texas 78229
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877-469-5300

MD Anderson in Sugar Land
Sugar Land, Texas 77478
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877-632-6789
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University of Utah Sugarhouse Health Center
Salt Lake City, Utah 84106
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888-424-2100
cancerinfo@hci.utah.edu

Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
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888-424-2100
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George E Wahlen Department of Veterans Affairs Medical Center
Salt Lake City, Utah 84148
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801-582-1565

Central Vermont Medical Center/National Life Cancer Treatment
Berlin, Vermont 05602
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802-225-5400

University of Vermont Medical Center
Burlington, Vermont 05401
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802-656-4101
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Bon Secours Saint Francis Medical Center
Midlothian, Virginia 23114
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804-893-8978
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Bon Secours Cancer Institute at Reynolds Crossing
Richmond, Virginia 23230
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804-893-8978
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VCU Massey Cancer Center at Stony Point
Richmond, Virginia 23235
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Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia 23298
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CTOclinops@vcu.edu

VCU Community Memorial Health Center
South Hill, Virginia 23970
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nemer.elmouallem@vcuhealth.org

FHCC Overlake
Bellevue, Washington 98004
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425-454-2148

Seattle Cancer Care Alliance at EvergreenHealth
Kirkland, Washington 98034
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425-899-6000

FHCC South Lake Union
Seattle, Washington 98109
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800-804-8824

FHCC at Northwest Hospital
Seattle, Washington 98133
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206-606-5800

University of Washington Medical Center - Montlake
Seattle, Washington 98195
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800-804-8824

West Virginia University Healthcare
Morgantown, West Virginia 26506
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304-293-7374
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Langlade Hospital and Cancer Center
Antigo, Wisconsin 54409
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715-623-9869
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Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
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800-782-8581
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Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
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Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin 53051
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262-257-5100

Medical College of Wisconsin
Milwaukee, Wisconsin 53226
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414-805-3666

Zablocki Veterans Administration Medical Center
Milwaukee, Wisconsin 53295
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888-469-6614

Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin 54548
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800-782-8581
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Cancer Center of Western Wisconsin
New Richmond, Wisconsin 54017
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952-993-1517
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Drexel Town Square Health Center
Oak Creek, Wisconsin 53154
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Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin 54868
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Ascension Saint Michael's Hospital
Stevens Point, Wisconsin 54481
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715-847-2353
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Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin 54482
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Aspirus Regional Cancer Center
Wausau, Wisconsin 54401
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877-405-6866

Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin 53095
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414-805-0505

Diagnostic and Treatment Center
Weston, Wisconsin 54476
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888-799-3989
oncology.clinical.trials@marshfieldresearch.org

Marshfield Medical Center - Weston
Weston, Wisconsin 54476
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800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin 54494
Contact:
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715-422-7718

More Details

NCT ID
NCT03678025
Status
Recruiting
Sponsor
SWOG Cancer Research Network

Study Contact

Dana Sparks, MAT
2106148808
dsparks@swog.org

Detailed Description

PRIMARY OBJECTIVES: I. To compare overall survival in metastatic prostate cancer patients who are randomized to standard systemic therapy (SST) plus definitive treatment of the primary tumor versus standard systemic therapy alone. SECONDARY OBJECTIVES: I. To compare overall survival in metastatic prostate cancer patients who received SST plus surgical excision of the primary tumor versus SST alone in the subset who specify the surgical intent stratification factor. II. To compare the rate of symptomatic local progression between the treatment arms. III. To compare progression-free survival (PFS) between the two treatment arms. IV. To compare rates of progression-free survival between arms for the subsets of patients with and without metastasis directed therapy (MDT) to oligometastatic sites. QUALITY OF LIFE OBJECTIVES: I. To compare between arms patient-reported urinary function and urinary bother over time (after initiation of SST at 6 months, 1, 2, and 3 years) using the Expanded Prostate Cancer Index Composite (EPIC) and patient-reported pain and physical functioning using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) between patients receiving standard systemic therapy and those receiving systemic therapy and definitive management of the primary prostate cancer. OTHER OBJECTIVES: I. To bank tissue and whole blood specimens for future use. OUTLINE: INDUCTION: Participants receive 1 of 6 acceptable forms of SST for 22-28 weeks. I. Participants undergo a bilateral orchiectomy. II. Participants receive goserelin acetate subcutaneously (SC) every 28 days or 12 weeks, histrelin acetate SC every 12 months, leuprolide acetate SC or intramuscularly (IM) every 1, 3, 4, or 6 months, and triptorelin every 1, 3, or 6 months. III. Participants receive goserelin acetate SC every 28 days or 12 weeks, histrelin acetate SC every 12 months, leuprolide acetate SC or IM every 1, 3, 4, or 6 months, and triptorelin every 1, 3, or 6 months. Participants also receive nilutamide orally (PO) daily, flutamide PO every 8 hours, and bicalutamide PO daily. IV. Participants receive degarelix via injection for 2 doses and then every 28 days. V. Participants receive nilutamide PO daily, flutamide PO every 8 hours, and bicalutamide PO daily. Participants also receive docetaxel over 1 hour every 3 weeks with or without prednisone PO every 12 hours. VI. Participants receive nilutamide PO daily, flutamide PO every 8 hours, and bicalutamide PO daily. Participants also receive abiraterone PO daily or prednisone PO every 12 hours. After completion of 22-28 weeks of SST, participants are then randomized to 1 of 2 arms. ARM I: Participants receive 1 acceptable form of SST as in Induction except for treatment with docetaxel and prednisone. ARM II: Participants receive 1 acceptable form of SST as in Induction except for treatment with docetaxel and prednisone. Participants undergo prostatectomy within 8 weeks after randomization or radiation therapy within 4 weeks of randomization. After completion of study treatment, participants are followed up for 8 years.