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

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

Mayo Clinic Hospital
Phoenix, Arizona 85054
Contact:
Site Public Contact
855-776-0015

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
800-327-2873

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

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

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

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

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

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

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

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

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

Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California 95051
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente Cancer Treatment Center
South San Francisco, California 94080
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

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

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

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

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

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

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

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

UF Cancer Center at Orlando Health
Orlando, Florida 32806
Contact:
Site Public Contact
321-841-7246
CancerClinicalTrials@orlandohealth.com

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

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

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

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

University of Chicago Comprehensive Cancer Center
Chicago, Illinois 60637
Contact:
Site Public Contact
773-702-8222
cancerclinicaltrials@bsd.uchicago.edu

Decatur Memorial Hospital
Decatur, Illinois 62526
Contact:
Site Public Contact
217-876-4740
rhamrick@dmhhs.org

Crossroads Cancer Center
Effingham, Illinois 62401
Contact:
Site Public Contact
217-876-4740
rhamrick@dmhhs.org

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

Southwest Illinois Health Services LLP
Swansea, Illinois 62226
Contact:
Site Public Contact
618-236-1000
lynns@thecancercenter.com

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

Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202
Contact:
Site Public Contact
317-278-5632
iutrials@iu.edu

McFarland Clinic PC - Ames
Ames, Iowa 50010
Contact:
Site Public Contact
515-956-4132

University of Kansas Cancer Center
Kansas City, Kansas 66160
Contact:
Site Public Contact
913-945-7552
ctnursenav@kumc.edu

University of Kansas Cancer Center-Overland Park
Overland Park, Kansas 66210
Contact:
Site Public Contact
913-945-7552
ctnursenav@kumc.edu

University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas 66205
Contact:
Site Public Contact
913-945-7552
ctnursenav@kumc.edu

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

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

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

Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland 21287
Contact:
Site Public Contact
410-955-8804
jhcccro@jhmi.edu

Lahey Hospital and Medical Center
Burlington, Massachusetts 01805
Contact:
Site Public Contact
781-744-8027

Saint Joseph Mercy Hospital
Ann Arbor, Michigan 48106
Contact:
Site Public Contact
734-712-3671
stephanie.couch@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
734-712-3671
stephanie.couch@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
734-712-3671
stephanie.couch@stjoeshealth.org

Saint Joseph Mercy Chelsea
Chelsea, Michigan 48118
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

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

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

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

Mayo Clinic
Rochester, Minnesota 55905
Contact:
Site Public Contact
855-776-0015

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

University of Mississippi Medical Center
Jackson, Mississippi 39216
Contact:
Site Public Contact
601-815-6700

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

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

The University of Kansas Cancer Center-North
Kansas City, Missouri 64154
Contact:
Site Public Contact
913-945-7552
ctnursenav@kumc.edu

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

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

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

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

New Hampshire Oncology Hematology PA-Hooksett
Hooksett, New Hampshire 03106
Contact:
Site Public Contact
800-339-6484

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

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

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

Mission Hospital Inc-Memorial Campus
Asheville, North Carolina 28801
Contact:
Site Public Contact
828-213-4150
leslie.verner@msj.org

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

Mercy Medical Center
Canton, Ohio 44708
Contact:
Site Public Contact
888-293-4673

University of Cincinnati/Barrett Cancer Center
Cincinnati, Ohio 45219
Contact:
Site Public Contact
513-558-4553
uchealthnews@uc.edu

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

Kettering Medical Center
Kettering, Ohio 45429
Contact:
Site Public Contact
937-775-1350
som_dcop@wright.edu

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

Legacy Mount Hood Medical Center
Gresham, Oregon 97030
Contact:
Site Public Contact
503-413-2150

Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon 97210
Contact:
Site Public Contact
800-220-4937
cancer@lhs.org

Oregon Health and Science University
Portland, Oregon 97239
Contact:
Site Public Contact
503-494-1080
trials@ohsu.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

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

Greenville Health System Cancer Institute-Faris
Greenville, South Carolina 29605
Contact:
Site Public Contact
864-241-6251
kwilliams8@ghs.org

Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina 29615
Contact:
Site Public Contact
864-241-6251
kwilliams8@ghs.org

Greenville Health System Cancer Institute-Greer
Greer, South Carolina 29650
Contact:
Site Public Contact
864-241-6251
kwilliams8@ghs.org

Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina 29672
Contact:
Site Public Contact
864-241-6251
kwilliams8@ghs.org

Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina 29307
Contact:
Site Public Contact
864-241-6251
kwilliams8@ghs.org

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

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

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

American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork, Utah 84003
Contact:
Site Public Contact
801-855-4100
officeofresearch@imail.org

Sandra L Maxwell Cancer Center
Cedar City, Utah 84720
Contact:
Site Public Contact
435-868-5680
officeofresearch@imail.org

Logan Regional Hospital
Logan, Utah 84321
Contact:
Site Public Contact
435-716-6400
officeofresearch@imail.org

Intermountain Medical Center
Murray, Utah 84107
Contact:
Site Public Contact
801-507-3950
officeofresearch@imail.org

McKay-Dee Hospital Center
Ogden, Utah 84403
Contact:
Site Public Contact
801-387-7426
officeofresearch@imail.org

Utah Valley Regional Medical Center
Provo, Utah 84604
Contact:
Site Public Contact
801-357-7965
officeofresearch@imail.org

Riverton Hospital
Riverton, Utah 84065
Contact:
Site Public Contact
801-507-3950
officeofresearch@imail.org

Dixie Medical Center Regional Cancer Center
Saint George, Utah 84770
Contact:
Site Public Contact
435-688-4167
officeofresearch@imail.org

Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah 84106
Contact:
Site Public Contact
801-933-6070
officeofresearch@imail.org

Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
Contact:
Site Public Contact
888-424-2100
cancerinfo@hci.utah.edu

LDS Hospital
Salt Lake City, Utah 84143
Contact:
Site Public Contact
801-408-1347
officeofresearch@imail.org

Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia 23298
Contact:
Site Public Contact
804-628-1939
mwellons@vcu.edu

University of Washington Medical Center
Seattle, Washington 98195
Contact:
Site Public Contact
800-804-8824

Legacy Salmon Creek Hospital
Vancouver, Washington 98686
Contact:
Site Public Contact
503-413-2150

Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin 54601
Contact:
Site Public Contact
855-776-0015

Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Community Memorial Hospital
Menomonee Falls, Wisconsin 53051
Contact:
Site Public Contact
262-257-5100

Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Contact:
Site Public Contact
414-805-4380

Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin 54548
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin 54868
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Marshfield Clinic Stevens Point Center
Stevens Point, Wisconsin 54482
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

The Alyce and Elmore Kraemer Cancer Care Center
West Bend, Wisconsin 53095
Contact:
Site Public Contact
866-680-0505

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

More Details

NCT ID
NCT03678025
Status
Recruiting
Sponsor
Southwest Oncology Group

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.