Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score
Purpose
This phase III trial uses the Decipher risk score to guide intensification (for higher Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to better match therapies to an individual patient's cancer aggressiveness. The Decipher risk score evaluates a prostate cancer tumor for its potential for spreading. In patients with low risk scores, this trial compares radiation therapy alone to the usual treatment of radiation therapy and hormone therapy (androgen deprivation therapy). Radiation therapy uses high energy x-rays or particles to kill tumor cells and shrink tumors. Androgen deprivation therapy blocks the production or interferes with the action of male sex hormones such as testosterone, which plays a role in prostate cancer development. Giving radiation treatment alone may be the same as the usual approach in controlling the cancer and preventing it from spreading, while avoiding the side effects associated with hormonal therapy. In patients with higher Decipher gene risk, this trial compares the addition of darolutamide to usual treatment radiation therapy and hormone therapy, to usual treatment. Darolutamide blocks the actions of the androgens (e.g. testosterone) in the tumor cells and in the body. The addition of darolutamide to the usual treatment may better control the cancer and prevent it from spreading.
Condition
- Prostate Adenocarcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of the prostate within 270 days prior to registration - Unfavorable intermediate risk prostate cancer, defined as having ALL the following bulleted criteria: - Has at least one intermediate risk factor (IRF): - PSA 10-20 ng/mL - Clinical stage T2b-c (digital rectal examination [DRE] and/or imaging) by American Joint Committee on Cancer (AJCC) 8th edition - Gleason score 7 (Gleason 3+4 or 4+3 [ International Society of Urological Pathology (ISUP) Grade Group 2-3]) - Has ONE or more of the following 'unfavorable' intermediate-risk designators: - > 1 immature reticulocyte fraction (IRF) - Gleason 4+3=7 (ISUP Grade Group 3) - >= 50% of biopsy cores positive - Biopsies may include 'sextant' sampling of right/left regions of the prostate, often labeled base, mid-gland and apex. All such 'sextant' biopsy cores should be counted. Men may also undergo 'targeted' sampling of prostate lesions (guided by MRI, ultrasound or other approaches). A targeted lesion that is biopsied more than once and demonstrates cancer (regardless of number of targeted cores involved) should count as a single additional positive core sampled and positive. In cases of uncertainty, count the biopsy sampling as sextant core(s) - Absence of high-risk features - Appropriate stage for study entry based on the following diagnostic workup: - History/physical examination within 120 days prior to registration; - Negative bone imaging (M0) within 120 days prior to registration; Note: Tc-99m bone scan or sodium fluoride (NaF) positron emission tomography (PET) are allowed. Equivocal bone scan findings are allowed if plain films X-ray, computed tomography (CT) or magnetic resonance imaging (MRI) are negative for metastasis at the concerned site(s). While a negative fluciclovine, choline, or prostate specific membrane antigen (PSMA) PET may be counted as acceptable substitute for bone imaging, any suspicious findings must be confirmed and correlated with conventional imaging (Tc-99m bone scan, NaF PET, CT, X-ray, or MRI) to determine eligibility based on the latter modalities (e.g. M0 based on conventional imaging modalities) - Clinically negative lymph nodes (N0) as established by conventional imaging (pelvic +/- abdominal CT or MR), within 120 days prior to registration. Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are =< 1.0 cm in short axis and/or if biopsy is negative. Note: While a negative fluciclovine, choline, or prostate specific membrane antigen (PSMA) PET may be counted as acceptable substitute for pelvic imaging, any suspicious findings must be confirmed by conventional imaging (CT, MRI or biopsy). If the findings do not meet pathological criteria based on the latter modalities (e.g. node =< 10 mm in short axis, negative biopsy), the patient will still be eligible - Age >= 18 - Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 120 days prior to registration - Non-castrate testosterone level (> 50 ng/dL) within 120 days prior to registration - Absolute neutrophil >= 1,000 cells/mm^3 (within 120 days prior to registration) - Hemoglobin >= 8.0 g/dL, independent of transfusion and/or growth factors (within 120 days prior to registration) - Platelet count >= 100,000 cells/mm^3 independent of transfusion and/or growth factors (within 120 days prior to registration) - Creatinine clearance (CrCl) >= 30 mL/min estimated by Cockcroft-Gault equation (within 120 days prior to registration) - For African American patients specifically whose renal function is not considered adequate by the formula above, an alternative formula that takes race into account (Chronic Kidney Disease Epidemiology Collaboration CKD-EPI formula) should be used for calculating the related estimated glomerular filtration rate (GFR) with a correction factor for African American race creatinine clearance for trial eligibility, where GFR >= 30 mL/min/1.73m^2 will be considered adequate - Total bilirubin: 1.5 =< institutional upper limit of normal (ULN) (within 120 days prior to registration) (Note: In subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin. If direct bilirubin is less than or equal to 1.5 x ULN, subject is eligible) - Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]): =< 2.5 x institutional ULN (within 120 days prior to registration) - Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial; Note: HIV testing is not required for eligibility for this protocol - For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. - Note: Known positive test for hepatitis B virus surface antigen (HBV sAg) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy. Patients who are immune to hepatitis B (anti-Hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B) - For patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load - Note: Known positive test for hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy - The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information
Exclusion Criteria
- Previous radical surgery (prostatectomy) or any form of curative-intent ablation whether focal or whole-gland (e.g., cryosurgery, high intensity focused ultrasound [HIFU], laser thermal ablation, etc.) for prostate cancer - Definitive clinical or radiologic evidence of metastatic disease (M1) - Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years. History of or current diagnosis of hematologic malignancy is not allowed - Prior radiotherapy to the prostate/pelvis region that would result in overlap of radiation therapy fields - Previous bilateral orchiectomy - Previous hormonal therapy, such as luteinizing hormone-releasing hormone (LHRH) agonists (e.g., leuprolide, goserelin, buserelin, triptorelin) or LHRH antagonist (e.g. degarelix), anti-androgens (e.g., flutamide, bicalutamide, cyproterone acetate). ADT started prior to study registration is not allowed - Prior use of 5-alpha-reductase inhibitors is allowed, however, it must be stopped prior to enrollment on the study with at least a 30 day washout period before baseline study PSA measure and registration - Active testosterone replacement therapy; any replacement therapy must be stopped at least 30 days prior to registration - Severe, active co-morbidity defined as follows: - Current severe or unstable angina; - New York Heart Association Functional Classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification) - History of any condition that in the opinion of the investigator, would preclude participation in this study - Inability to swallow oral pills - High risk features, which includes any of the following: - Gleason 8-10 [ISUP Grade Group 4-5] - PSA > 20 - cT3-4 by digital exam OR gross extra-prostatic extension on imaging [indeterminate MRI evidence will not count and the patient will be eligible]
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Arm I (RT) |
Patients undergo RT using a recognized regimen (2-3 days a week or 5 days a week for 2-11 weeks) in the absence of disease progression or unacceptable toxicity. |
|
Experimental Arm II (RT, ADT) |
Patients undergo RT as Arm I. Patients also receive ADT consisting of leuprolide, goserelin, buserelin, histrelin, triptorelin, degarelix, or relugolix at the discretion of the treating physician, for 6 months in the absence of disease progression or unacceptable toxicity. Patients may also receive bicalutamide or flutamide for 0, 30 or 180 days. |
|
Experimental Arm III (RT, ADT) |
Patients receive treatment as in Arm II. |
|
Experimental Arm IV (RT, ADT, darolutamide) |
Patients receive RT and ADT as in Arm II. Patients also receive darolutamide PO BID on days 1-90. Treatment repeats every 90 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. |
|
Recruiting Locations
Birmingham, Alabama 35233
Gilbert, Arizona 85234
Site Public Contact
602-747-9738
Gilbert, Arizona 85297
Peoria, Arizona 85381
Site Public Contact
623-773-2873
Phoenix, Arizona 85027
Scottsdale, Arizona 85258
Surprise, Arizona 85374
Little Rock, Arkansas 72205
Site Public Contact
501-686-8274
Auburn, California 95603
Bakersfield, California 93301
Site Public Contact
661-323-4673
Beverly Hills, California 90211
Cameron Park, California 95682
Corona, California 92879
Duarte, California 91010
Dublin, California 94568
Site Public Contact
877-642-4691
Encinitas, California 92024
Site Public Contact
760-536-7700
Fremont, California 94538
Fremont, California 94538
Site Public Contact
510-745-6433
Fresno, California 93720
Greenbrae, California 94904
Site Public Contact
415-925-7325
Irvine, California 92612
Irvine, California 92618
Site Public Contact
877-467-3411
La Jolla, California 92093
Lancaster, California 93534
Los Angeles, California 90033
Los Angeles, California 90033
Site Public Contact
323-865-0451
Los Angeles, California 90048
Site Public Contact
310-423-8965
Marysville, California 95901
Site Public Contact
530-749-4400
Modesto, California 95355
Modesto, California 95356
Napa, California 94558
Site Public Contact
707-521-3830
Oakland, California 94611
Orange, California 92868
Site Public Contact
714-734-6220
Orange, California 92868
Palo Alto, California 94301
Roseville, California 95661
Roseville, California 95661
Sacramento, California 95814
Sacramento, California 95816
Sacramento, California 95817
Site Public Contact
916-734-3089
Sacramento, California 95823
San Diego, California 92121
Site Public Contact
858-299-5982
San Francisco, California 94115
San Francisco, California 94158
San Jose, California 95119
San Leandro, California 94577
Santa Barbara, California 93105
Santa Clara, California 95051
Santa Rosa, California 95403
South Pasadena, California 91030
South San Francisco, California 94080
Sunnyvale, California 94086
Tarzana, California 91356
Site Public Contact
818-981-3818
Torrance, California 90503
Site Public Contact
877-467-3411
Torrance, California 90505
Torrance, California 90509
Site Public Contact
310-517-4665
Truckee, California 96161
Site Public Contact
530-582-6450
Upland, California 91786
Vallejo, California 94589
Vallejo, California 94589
Walnut Creek, California 94596
Aurora, Colorado 80045
Site Public Contact
720-848-0650
Boulder, Colorado 80304
Colorado Springs, Colorado 80909
Site Public Contact
719-365-2406
Colorado Springs, Colorado 80920
Site Public Contact
719-364-6700
Edwards, Colorado 81632
Site Public Contact
970-569-7429
Fort Collins, Colorado 80524
Site Public Contact
970-297-6150
Fort Collins, Colorado 80528
Greeley, Colorado 80631
Greeley, Colorado 80631
Highlands Ranch, Colorado 80129
Site Public Contact
720-848-0650
Loveland, Colorado 80538
Site Public Contact
970-203-7083
Loveland, Colorado 80539
Bridgeport, Connecticut 06606
Site Public Contact
860-972-4700
Greenwich, Connecticut 06830
Guilford, Connecticut 06437
Hartford, Connecticut 06102
Site Public Contact
860-545-5363
Meriden, Connecticut 06451
Site Public Contact
866-662-5678
New Britain, Connecticut 06050
Site Public Contact
860-224-5660
New Haven, Connecticut 06520
Norwalk, Connecticut 06856
Trumbull, Connecticut 06611
Waterford, Connecticut 06385
Millville, Delaware 19967
Newark, Delaware 19713
Newark, Delaware 19713
Rehoboth Beach, Delaware 19971
Washington, District of Columbia 20037
Site Public Contact
202-741-2981
Bay Pines, Florida 33744
Boca Raton, Florida 33486
Site Public Contact
561-955-4800
Gainesville, Florida 32610
Jupiter, Florida 33458
Site Public Contact
561-745-5768
Plantation, Florida 33324
Weston, Florida 33331
Atlanta, Georgia 30303
Site Public Contact
404-489-9164
Atlanta, Georgia 30308
Atlanta, Georgia 30308
Site Public Contact
888-946-7447
Atlanta, Georgia 30322
Site Public Contact
404-778-1868
Atlanta, Georgia 30342
Site Public Contact
404-851-7115
Gainesville, Georgia 30501
Johns Creek, Georgia 30097
Savannah, Georgia 31405
Boise, Idaho 83712
Fruitland, Idaho 83619
Meridian, Idaho 83642
Nampa, Idaho 83687
Twin Falls, Idaho 83301
Aurora, Illinois 60504
Barrington, Illinois 60010
Site Public Contact
847-842-4847
Bloomington, Illinois 61704
Canton, Illinois 61520
Carthage, Illinois 62321
Chicago, Illinois 60611
Chicago, Illinois 60612
Chicago, Illinois 60612
Site Public Contact
312-355-3046
Chicago, Illinois 60657
Site Public Contact
773-296-5360
Crystal Lake, Illinois 60014
Danville, Illinois 61832
Decatur, Illinois 62526
DeKalb, Illinois 60115
Downers Grove, Illinois 60515
Effingham, Illinois 62401
Elgin, Illinois 60123
Site Public Contact
847-429-2907
Elmhurst, Illinois 60126
Eureka, Illinois 61530
Galesburg, Illinois 61401
Geneva, Illinois 60134
Hazel Crest, Illinois 60429
Site Public Contact
708-799-9995
Kewanee, Illinois 61443
Lake Forest, Illinois 60045
Libertyville, Illinois 60048
Libertyville, Illinois 60048
Macomb, Illinois 61455
Mattoon, Illinois 61938
Naperville, Illinois 60540
Site Public Contact
630-646-6075
O'Fallon, Illinois 62269
Oak Lawn, Illinois 60453-2699
Site Public Contact
800-323-8622
Orland Park, Illinois 60462
Ottawa, Illinois 61350
Palos Heights, Illinois 60463
Park Ridge, Illinois 60068
Site Public Contact
847-384-3621
Pekin, Illinois 61554
Peoria, Illinois 61615
Peoria, Illinois 61636
Peoria, Illinois 61637
Peru, Illinois 61354
Princeton, Illinois 61356
Rockford, Illinois 61114
Shiloh, Illinois 62269
Springfield, Illinois 62781
Urbana, Illinois 61801
Warrenville, Illinois 60555
Washington, Illinois 61571
Cedar Rapids, Iowa 52402
Des Moines, Iowa 50309
Site Public Contact
515-241-6727
Kansas City, Kansas 66160
Olathe, Kansas 66061
Overland Park, Kansas 66210
Overland Park, Kansas 66211
Salina, Kansas 67401
Topeka, Kansas 66606
Site Public Contact
785-270-4939
Topeka, Kansas 66606
Site Public Contact
785-295-8000
Westwood, Kansas 66205
Wichita, Kansas 67214
Lexington, Kentucky 40504
Metairie, Louisiana 70006
Metairie, Louisiana 70006
Portland, Maine 04102
Site Public Contact
207-885-7565
Scarborough, Maine 04074
South Portland, Maine 04106
Annapolis, Maryland 21401
Baltimore, Maryland 21201
Baltimore, Maryland 21201
Site Public Contact
800-888-8823
Bel Air, Maryland 21014
Site Public Contact
443-643-3010
Easton, Maryland 21601
Glen Burnie, Maryland 21061
Site Public Contact
410-553-8100
Ocean Pines, Maryland 21811
Salisbury, Maryland 21801
Beverly, Massachusetts 01915
Site Public Contact
978-922-3000
Burlington, Massachusetts 01805
Gloucester, Massachusetts 01930
Site Public Contact
978-283-4000
Peabody, Massachusetts 01960
Winchester, Massachusetts 01890
Ann Arbor, Michigan 48106
Ann Arbor, Michigan 48109
Site Public Contact
800-865-1125
Bay City, Michigan 48706
Brighton, Michigan 48114
Brighton, Michigan 48114
Brownstown, Michigan 48183
Canton, Michigan 48188
Canton, Michigan 48188
Chelsea, Michigan 48118
Chelsea, Michigan 48118
Clarkston, Michigan 48346
Clarkston, Michigan 48346
Clinton Township, Michigan 48038
Detroit, Michigan 48201
Detroit, Michigan 48202
Farmington Hills, Michigan 48334
Farmington Hills, Michigan 48334
Flint, Michigan 48503
Flint, Michigan 48532
Grand Rapids, Michigan 49503
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
Lansing, Michigan 48910
Lansing, Michigan 48912
Lapeer, Michigan 48446
Livonia, Michigan 48154
Macomb, Michigan 48044
Madison Heights, Michigan 48071
Mount Clemens, Michigan 48043
Niles, Michigan 49120
Site Public Contact
616-391-1230
Novi, Michigan 48377
Petoskey, Michigan 49770
Pontiac, Michigan 48341
Port Huron, Michigan 48060
Royal Oak, Michigan 48073
Site Public Contact
248-551-7695
Saginaw, Michigan 48601
Saint Joseph, Michigan 49085
Saint Joseph, Michigan 49085
Tawas City, Michigan 48764
Traverse City, Michigan 49684
Troy, Michigan 48085
Site Public Contact
248-551-7695
Troy, Michigan 48098
West Bloomfield, Michigan 48322
Wyoming, Michigan 49519
Ypsilanti, Michigan 48197
Duluth, Minnesota 55805
Duluth, Minnesota 55805
Minneapolis, Minnesota 55415
Saint Louis Park, Minnesota 55416
Saint Paul, Minnesota 55101
Cape Girardeau, Missouri 63703
Columbia, Missouri 65212
Site Public Contact
573-882-7440
Creve Coeur, Missouri 63141
Farmington, Missouri 63640
Site Public Contact
314-996-5569
Kansas City, Missouri 64154
Lee's Summit, Missouri 64064
North Kansas City, Missouri 64116
Rolla, Missouri 65401
Saint Louis, Missouri 63104
Site Public Contact
314-977-4440
Saint Louis, Missouri 63110
Saint Louis, Missouri 63129
Saint Louis, Missouri 63131
Site Public Contact
314-996-5569
Saint Louis, Missouri 63136
Saint Peters, Missouri 63376
Sainte Genevieve, Missouri 63670
Site Public Contact
314-996-5569
Springfield, Missouri 65804
Site Public Contact
417-269-4520
Sullivan, Missouri 63080
Site Public Contact
314-996-5569
Sunset Hills, Missouri 63127
Site Public Contact
314-996-5569
Billings, Montana 59101
Butte, Montana 59701
Site Public Contact
406-723-2621
Great Falls, Montana 59405
Bellevue, Nebraska 68123
Omaha, Nebraska 68118
Site Public Contact
402-559-5600
Omaha, Nebraska 68198
Concord, New Hampshire 03301
Site Public Contact
603-224-2556
Lebanon, New Hampshire 03756
Manchester, New Hampshire 03103
Site Public Contact
800-339-6484
Basking Ridge, New Jersey 07920
Site Public Contact
212-639-7592
Camden, New Jersey 08103
Site Public Contact
856-325-6757
Egg Harbor Township, New Jersey 08234
Site Public Contact
609-748-7200
Hamilton, New Jersey 08690
Site Public Contact
609-631-6946
Jersey City, New Jersey 07302
Livingston, New Jersey 07039
Middletown, New Jersey 07748
Site Public Contact
212-639-7592
Montvale, New Jersey 07645
Site Public Contact
212-639-7592
Mount Laurel, New Jersey 08054
New Brunswick, New Jersey 08903
Site Public Contact
732-235-7356
Newark, New Jersey 07101
Site Public Contact
732-235-7356
Newark, New Jersey 07112
Paramus, New Jersey 07652
Sewell, New Jersey 08080
Somerville, New Jersey 08876
Toms River, New Jersey 08755
Voorhees, New Jersey 08043
Site Public Contact
856-325-6757
Albuquerque, New Mexico 87106
Albuquerque, New Mexico 87110
Rio Rancho, New Mexico 87124
Bay Shore, New York 11706
Site Public Contact
516-734-8896
Bronx, New York 10461
Bronx, New York 10467
Brooklyn, New York 11215
Buffalo, New York 14263
Commack, New York 11725
Site Public Contact
212-639-7592
Dansville, New York 14437
Flushing, New York 11355
Forest Hills, New York 11375
Site Public Contact
718-520-6620
Glens Falls, New York 12801
Site Public Contact
518-926-6700
Greenlawn, New York 11740
Site Public Contact
516-734-8896
Harrison, New York 10604
Site Public Contact
212-639-7592
Lake Success, New York 11042
Site Public Contact
516-734-8896
New York, New York 10032
New York, New York 10065
Site Public Contact
212-434-4460
New York, New York 10065
Site Public Contact
212-639-7592
New York, New York 10075
Site Public Contact
516-734-8896
Rego Park, New York 11374
Site Public Contact
718-312-3446
Rochester, New York 14620
Site Public Contact
585-341-8113
Rochester, New York 14642
Site Public Contact
585-275-5830
Sleepy Hollow, New York 10591
Site Public Contact
914-366-1600
Staten Island, New York 10305
Site Public Contact
718-226-8888
Stony Brook, New York 11794
Site Public Contact
800-862-2215
Syracuse, New York 13210
Site Public Contact
315-464-5476
Uniondale, New York 11553
Site Public Contact
212-639-7592
Valhalla, New York 10595
Webster, New York 14580
Asheville, North Carolina 28801
Cary, North Carolina 27518
Site Public Contact
919-781-7070
Chapel Hill, North Carolina 27599
Durham, North Carolina 27705
Durham, North Carolina 27710
Site Public Contact
888-275-3853
Raleigh, North Carolina 27607
Raleigh, North Carolina 27609
Site Public Contact
919-862-5400
Raleigh, North Carolina 27614
Supply, North Carolina 28462
Site Public Contact
910-754-4716
Wilmington, North Carolina 28401
Site Public Contact
910-251-1839
Wilmington, North Carolina 28401
Site Public Contact
910-342-3000
Bismarck, North Dakota 58501
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Grand Forks, North Dakota 58201
Site Public Contact
701-780-6520
Akron, Ohio 44304
Akron, Ohio 44307
Avon, Ohio 44011
Site Public Contact
800-641-2422
Barberton, Ohio 44203
Beachwood, Ohio 44122
Cleveland, Ohio 44106
Cleveland, Ohio 44109
Cleveland, Ohio 44111
Cleveland, Ohio 44195
Columbus, Ohio 43210
Columbus, Ohio 43214
Columbus, Ohio 43215
Columbus, Ohio 43228
Delaware, Ohio 43015
Dublin, Ohio 43016
Mansfield, Ohio 44903
Mansfield, Ohio 44906
Marion, Ohio 43302
Mayfield Heights, Ohio 44124
Medina, Ohio 44256
Mentor, Ohio 44060
Parma, Ohio 44129
Ravenna, Ohio 44266
Sandusky, Ohio 44870
Strongsville, Ohio 44136
Sylvania, Ohio 43560
Warrensville Heights, Ohio 44122
Wooster, Ohio 44691
Oklahoma City, Oklahoma 73104
Bend, Oregon 97701
Gresham, Oregon 97030
Site Public Contact
503-413-2150
Portland, Oregon 97210
Portland, Oregon 97213
Portland, Oregon 97239
Tualatin, Oregon 97062
Site Public Contact
503-413-1742
Allentown, Pennsylvania 18104
Site Public Contact
610-776-4714
Altoona, Pennsylvania 16601
Beaver, Pennsylvania 15009
Bethlehem, Pennsylvania 18015
Site Public Contact
484-503-4151
Broomall, Pennsylvania 19008
Carlisle, Pennsylvania 17015
Chadds Ford, Pennsylvania 19317
Chambersburg, Pennsylvania 17201
Danville, Pennsylvania 17822
Dunmore, Pennsylvania 18512
Site Public Contact
888-808-6762
Easton, Pennsylvania 18045
Ephrata, Pennsylvania 17522
Site Public Contact
717-721-4840
Erie, Pennsylvania 16505
Erie, Pennsylvania 16544
Site Public Contact
814-452-5000
Farrell, Pennsylvania 16121
Gettysburg, Pennsylvania 17325
Site Public Contact
877-441-7957
Glen Mills, Pennsylvania 19342
Site Public Contact
610-284-8237
Greensburg, Pennsylvania 15601
Site Public Contact
724-838-1900
Harrisburg, Pennsylvania 17109
Hershey, Pennsylvania 17033-0850
Indiana, Pennsylvania 15701
Jefferson Hills, Pennsylvania 15025
Johnstown, Pennsylvania 15901
Site Public Contact
814-534-4724
Lebanon, Pennsylvania 17042
Lewisburg, Pennsylvania 17837
Meadville, Pennsylvania 16335
Mechanicsburg, Pennsylvania 17050
Monroeville, Pennsylvania 15146
Site Public Contact
412-858-7746
Monroeville, Pennsylvania 15146
Monroeville, Pennsylvania 15146
Moon, Pennsylvania 15108
Natrona Heights, Pennsylvania 15065
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19114
Pittsburgh, Pennsylvania 15212
Site Public Contact
877-284-2000
Pittsburgh, Pennsylvania 15215
Site Public Contact
412-784-4900
Pittsburgh, Pennsylvania 15224
Site Public Contact
412-578-5000
Pittsburgh, Pennsylvania 15232
Site Public Contact
412-647-8073
Pittsburgh, Pennsylvania 15232
Site Public Contact
412-621-2334
Pittsburgh, Pennsylvania 15237
Site Public Contact
412-367-6454
Pittsburgh, Pennsylvania 15243
Site Public Contact
412-502-3920
Pottsville, Pennsylvania 17901
Quakertown, Pennsylvania 18951
Site Public Contact
610-776-4714
Seneca, Pennsylvania 16346
Site Public Contact
814-676-7900
Stroudsburg, Pennsylvania 18360
West Chester, Pennsylvania 19380
West Reading, Pennsylvania 19611
Site Public Contact
610-988-9323
Wexford, Pennsylvania 15090
Wilkes-Barre, Pennsylvania 18711
Williamsport, Pennsylvania 17754
Willow Grove, Pennsylvania 19090
York, Pennsylvania 17403
Site Public Contact
877-441-7957
York, Pennsylvania 17408
Site Public Contact
717-724-6760
Bluffton, South Carolina 29910
Charleston, South Carolina 29425
Greenville, South Carolina 29601
Greenville, South Carolina 29607
Greenwood, South Carolina 29646
Greer, South Carolina 29651
Hilton Head Island, South Carolina 29926
Okatie, South Carolina 29909
Site Public Contact
843-273-7980
Spartanburg, South Carolina 29303
Sioux Falls, South Dakota 57104
Sioux Falls, South Dakota 57117-5134
Nashville, Tennessee 37203
Site Public Contact
615-342-1919
Nashville, Tennessee 37232
Site Public Contact
800-811-8480
Conroe, Texas 77384
Dallas, Texas 75237
Dallas, Texas 75390
Fort Sam Houston, Texas 78234
Site Public Contact
210-916-4837
Fort Worth, Texas 76104
Houston, Texas 77030
Houston, Texas 77079
League City, Texas 77573
Richardson, Texas 75080
San Antonio, Texas 78229
Sugar Land, Texas 77478
American Fork, Utah 84003
Cedar City, Utah 84720
Farmington, Utah 84025
Logan, Utah 84321
Murray, Utah 84107
Ogden, Utah 84403
Provo, Utah 84604
Riverton, Utah 84065
Saint George, Utah 84770
Salt Lake City, Utah 84106
Salt Lake City, Utah 84112
Salt Lake City, Utah 84143
Berlin, Vermont 05602
Site Public Contact
802-225-5400
Burlington, Vermont 05401
Saint Johnsbury, Vermont 05819
Charlottesville, Virginia 22908
Fairfax, Virginia 22031
Fairfax, Virginia 22033
Midlothian, Virginia 23114
Richmond, Virginia 23230
Richmond, Virginia 23298
Seattle, Washington 98101
Vancouver, Washington 98684
Vancouver, Washington 98686
Site Public Contact
503-413-2150
Walla Walla, Washington 99362
Antigo, Wisconsin 54409
Appleton, Wisconsin 54911
Appleton, Wisconsin 54915
Ashland, Wisconsin 54806
Brookfield, Wisconsin 53045
Burlington, Wisconsin 53105
Chilton, Wisconsin 53014
Eau Claire, Wisconsin 54701
Franklin, Wisconsin 53132
Germantown, Wisconsin 53022
Grafton, Wisconsin 53024
Green Bay, Wisconsin 54301
Site Public Contact
920-435-8326
Green Bay, Wisconsin 54301
Green Bay, Wisconsin 54303
Green Bay, Wisconsin 54311
Johnson Creek, Wisconsin 53038
Kenosha, Wisconsin 53142
Madison, Wisconsin 53718
Madison, Wisconsin 53792
Marinette, Wisconsin 54143
Menomonee Falls, Wisconsin 53051
Site Public Contact
262-257-5100
Mequon, Wisconsin 53097
Milwaukee, Wisconsin 53209
Milwaukee, Wisconsin 53211
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 53226
Site Public Contact
414-805-3666
Milwaukee, Wisconsin 53233
Milwaukee, Wisconsin 53295
Site Public Contact
888-469-6614
Minocqua, Wisconsin 54548
Mukwonago, Wisconsin 53149
Oak Creek, Wisconsin 53154
Site Public Contact
414-805-0505
Oconomowoc, Wisconsin 53066
Site Public Contact
262-928-7878
Oshkosh, Wisconsin 54904
Oshkosh, Wisconsin 54904
Racine, Wisconsin 53405
Racine, Wisconsin 53406
Rhinelander, Wisconsin 54501
Rice Lake, Wisconsin 54868
Sheboygan, Wisconsin 53081
Sheboygan, Wisconsin 53081
Stevens Point, Wisconsin 54481
Stevens Point, Wisconsin 54482
Sturgeon Bay, Wisconsin 54235-1495
Summit, Wisconsin 53066
Two Rivers, Wisconsin 54241
Waukesha, Wisconsin 53188
Wausau, Wisconsin 54401
Site Public Contact
877-405-6866
Wauwatosa, Wisconsin 53226
Wauwatosa, Wisconsin 53226
West Allis, Wisconsin 53227
West Bend, Wisconsin 53095
Site Public Contact
414-805-0505
Weston, Wisconsin 54476
Wisconsin Rapids, Wisconsin 54494
Site Public Contact
715-422-7718
More Details
- NCT ID
- NCT05050084
- Status
- Recruiting
- Sponsor
- NRG Oncology
Detailed Description
PRIMARY OBJECTIVES: I. To determine whether men with National Comprehensive Cancer Network (NCCN) unfavorable intermediate risk (UIR) prostate cancer and lower Decipher genomic risk (Decipher score < 0.40) treated with radiation therapy (RT) alone instead of 6 months androgen deprivation therapy (ADT) + RT experience non-inferior rate of distant metastasis. (De-intensification study) II. To determine whether men with NCCN UIR prostate cancer who are in the higher genomic risk (Decipher score >= 0.40) will have a superior metastasis-free survival through treatment intensification with darolutamide added to the standard of RT plus 6 months ADT. (Intensification study) SECONDARY OBJECTIVES: I. To compare overall survival (OS) between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions. II. To compare time to prostate specific antigen (PSA) failure between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions. III. To compare metastasis free survival (MFS) based on conventional imaging between the standard of care (RT plus 6 months of ADT) and de-intensification intervention (RT alone). IV. To compare MFS based on either conventional and/or molecular imaging between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions. V. To compare cumulative incidence of locoregional failure based upon conventional imaging and/ or biopsy between standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months ADT plus darolutamide) interventions. VI. To compare cumulative incidence of distant metastasis based upon conventional imaging between standard of care (RT plus 6 months of ADT) and intensification intervention (RT plus 6 months ADT plus darolutamide). VII. To compare cumulative incidence of distant metastasis based upon either conventional and/or molecular imaging between standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions. VIII. To compare prostate cancer-specific mortality between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions. IX. To compare sexual and hormonal related quality of life, as measured by the Expanded Prostate Cancer Index Composite-26 (EPIC), between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions. X. To compare fatigue, as measured by the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue instrument, between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions. XI. To compare cognition, as measured by the Functional Assessment of Chronic Illness Therapy-Cognitive (FACT-Cog) perceived cognitive abilities subscale, between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions. EXPLORATORY OBJECTIVES: I. To compare changes in cardio-metabolic markers, including body mass index, lipids, blood glucose, complete blood count (CBC), comprehensive metabolic panel (CMP), and hemoglobin (Hgb) A1c, between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions. II. To compare PSA failure-free survival with non-castrate testosterone and no additional therapies between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions. III. To compare cumulative incidence of locoregional failure based upon either conventional and/or molecular imaging between standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions. IV. To compare castrate-resistant prostate cancer (CRPC) between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions. V. To compare bowel and urinary function related quality of life, as measured by the Expanded Prostate Cancer Index Composite-26 (EPIC), between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions. VI. To compare time to testosterone recovery (defined as a T > 200ng/dL) between the standard of care (RT plus 6 months of ADT) and intensification (RT plus 6 months of ADT plus darolutamide) interventions. VII. To compare health utilities, as measured by the European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L), between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions. VIII. To develop and assess a machine learning/artificial intelligence algorithm for radiotherapy planning and/or quality assurance. IX. To perform future translational correlative studies using biological data, Decipher results, and clinical outcomes. OUTLINE: DE-INTENSIFICATION STUDY: Patients with Decipher score < 0.40 are randomized to 1 of 2 arms. ARM I: Patients undergo RT using a recognized regimen (2-3 days a week or 5 days a week for 2-11 weeks) in the absence of disease progression or unacceptable toxicity. ARM II: Patients undergo RT as Arm I. Patients also receive ADT consisting of leuprolide, goserelin, buserelin, histrelin, triptorelin, degarelix, or relugolix at the discretion of the treating physician, for 6 months in the absence of disease progression or unacceptable toxicity. Patients may also receive bicalutamide or flutamide for 0, 30 or 180 days. INTENSIFICATION STUDY: Patients with Decipher score >= 0.40 are randomized to 1 of 2 arms. ARM III: Patients receive treatment as in Arm II. ARM IV: Patients receive RT and ADT as in Arm II. Patients also receive darolutamide orally (PO) twice daily (BID). Treatment repeats every 90 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 3, 6, 12, 24, 36, 48 and 60 months.