Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery

• Sponsor: NRG Oncology (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03070886
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 612
• Locations: 314
• Arms: 2
• Anticipated Duration (Months): 171.4
• Patients Per Site: 1.9
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This randomized phase II/III trial studies docetaxel, antiandrogen therapy, and radiation therapy to see how well it works compared with antiandrogen therapy and radiation therapy alone in treating patients with prostate cancer that has been removed by surgery. Androgen can cause the growth of prostate cells. Antihormone therapy may lessen the amount of androgen made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving antiandrogen therapy and radiation therapy with or without docetaxel after surgery may kill any remaining tumor cells.

Condition or Disease	Intervention/Treatment	Phase
Stage I Prostate Adenocarcinoma; Stage II Prostate Adenocarcinoma; Stage III Prostate Adenocarcinoma	Drug: Bicalutamide; Drug: Docetaxel; Radiation: External Beam Radiation Therapy; Drug: Flutamide; Drug: Goserelin Acetate; Other: Laboratory Biomarker Analysis; Drug: Leuprolide Acetate; Drug: Nilutamide	Phase 2/Phase 3

Detailed Description

PRIMARY OBJECTIVES:

1. To assess the benefit of docetaxel as measured by improvement in freedom from progression (phase II) and subsequently metastasis free survival (phase III) when given in combination with radiation and androgen deprivation in treatment of high risk prostate cancer post-radical prostatectomy.

SECONDARY OBJECTIVES:

1. To assess overall survival. II. To assess local time to progression. III. To assess undetectable prostate-specific antigen (PSA) with a non-castrate testosterone at 2.5 years post treatment.

2. To assess the utility of genomic profiling in making adjuvant therapy decisions post-prostatectomy.

3. To assess toxicity of docetaxel in the post-operative setting when combined with radiation and androgen deprivation therapy.

4. To assess treatment response by genomically defined sub-groups of prostate cancer patients.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive androgen deprivation therapy comprising leuprolide acetate, goserelin acetate, bicalutamide, flutamide, or nilutamide for 6 months. Beginning 8 weeks after the start of androgen deprivation therapy, patients receive external beam radiation therapy (EBRT) for 7.5 weeks.

ARM II: Patients receive androgen deprivation therapy and EBRT as in Arm I. Within 4-6 weeks after completion of radiation therapy, patients receive docetaxel intravenously (IV) on day 1 of every 21 days for 6 courses in the absence of disease progression or unexpected toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years, then every 6 months for 3 years, and then yearly.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 612 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II-III Trial of Adjuvant Radiotherapy Following Radical Prostatectomy With or Without Adjuvant Docetaxel
• Actual Study Start Date: Jan 16, 2017
• Anticipated Primary Completion Date: May 1, 2026
• Anticipated Study Completion Date: May 1, 2031

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm I (androgen deprivation therapy, EBRT) Patients receive androgen deprivation therapy comprising leuprolide acetate, goserelin acetate, bicalutamide, flutamide, or nilutamide for 6 months. Beginning 8 weeks after the start of androgen deprivation therapy, patients receive EBRT for 7.5 weeks.	Drug: Bicalutamide; Given orally; Other Names: Casodex Cosudex ICI 176,334 ICI 176334 ; Radiation: External Beam Radiation Therapy; Undergo external beam radiation therapy; Other Names: Definitive Radiation Therapy EBRT External Beam Radiotherapy External Beam RT external radiation External Radiation Therapy external-beam radiation ; Drug: Flutamide; 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; Other Names: ZDX Zoladex ; Other: Laboratory Biomarker Analysis; Correlative studies; Drug: Leuprolide Acetate; 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; Other Names: Anandron Nilandron RU-23908
Experimental: Arm II (androgen deprivation therapy, EBRT, docetaxel) Patients receive androgen deprivation therapy and EBRT as in Arm I. Within 4-6 weeks after completion of radiation therapy, patients receive docetaxel IV on day 1 of every 21 days for 6 courses in the absence of disease progression or unexpected toxicity.	Drug: Bicalutamide; Given orally; Other Names: Casodex Cosudex ICI 176,334 ICI 176334 ; Drug: Docetaxel; Given IV; Other Names: Docecad RP56976 Taxotere Taxotere Injection Concentrate ; Radiation: External Beam Radiation Therapy; Undergo external beam radiation therapy; Other Names: Definitive Radiation Therapy EBRT External Beam Radiotherapy External Beam RT external radiation External Radiation Therapy external-beam radiation ; Drug: Flutamide; 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; Other Names: ZDX Zoladex ; Other: Laboratory Biomarker Analysis; Correlative studies; Drug: Leuprolide Acetate; 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; Other Names: Anandron Nilandron RU-23908

Outcome Measures

Primary Outcome Measures

1. Freedom from progression (FFP) (Phase II) [From time of randomization to first event, assessed up to 43 months]

   Will be determined with a one-sided stratified log-rank test when 89 FFP events have been observed. Both unadjusted and adjusted hazard ratios and the respective 95% confidence interval will be computed. Events for FFP will be the first occurrence of biochemical failure by PSA >= 0.4 ng/ml over the nadir PSA confirmed by a second PSA higher than the first by any amount, recurrence (local, regional or distant), institution of secondary androgen deprivation therapy and death from any cause.

2. Metastasis free survival (MFS) (Phase III) [From time of randomization to first occurrence of distant metastasis or death from any cause, assessed up to 9.5 years]

   Will be measured with a one-sided stratified log-rank test when 282 MFS events have been observed. Both unadjusted and adjusted hazard ratios and the respective 95% confidence interval will be computed.

Secondary Outcome Measures

1. Overall survival [Time to death from any cause assessed up to 9.5 years]

   Will be analyzed using log-rank methodology and Cox proportional models. Tests for violations of proportionality will performed for the survival models. Both unadjusted and adjusted hazard ratios and the respective 95% confidence interval will be computed.

2. Time to local progression [Baseline to local or regional recurrence ignoring biochemical failure and distant recurrence and censoring for death, assessed up to 2.5 years]

   Data will be summarized by cumulative incidence curves. Fine and Gray models will be used to adjust inference for competing risks. Both unadjusted and adjusted hazard ratios and the respective 95% confidence intervals will be computed.

3. Proportions of patients with Grade 3 through Grade 5 adverse events that are either related to study drug or not graded according to NCI CTCAE version 3.0 [Up to 30 days post radiation therapy]

   Frequencies, proportions and severity of acute adverse events by treatment arm will be presented. Specifically, Grade 3 - 5 adverse events will be tallied. Adverse events related to study drug will also be tallied.

4. Proportion of undetectable PSA with a non-castrate testosterone [At 2.5 years post treatment]

   Both unadjusted and adjusted odds ratios and the respective 95% confidence interval will be computed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients post-prostatectomy with baseline Gleason >= 7 (per prostatectomy pathology) and baseline PSA prior to the start of androgen deprivation therapy nadir >= 0.2 ng/ml (post-operative value is never undetectable) obtained prior to step 1 registration

• Baseline testosterone level obtained post prostatectomy prior to the start of androgen deprivation therapy and prior to step 1 registration

• Pathologically (histologically) proven diagnosis of adenocarcinoma of the prostate as confirmed at time of prostatectomy; prostatectomy must have been performed =< 365 days (1 year) prior to step 1 registration

• Primary treatment with radical prostatectomy

• Any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted

• Prior ablative treatment for treatment of benign prostatic hypertrophy or focal high-intensity focused ultrasound therapy (HIFU) prior to prostatectomy is allowed

• Prior androgen deprivation (luteinizing hormone-releasing hormone [LHRH] agonist and/or non-steroidal anti-androgen) is allowed if discontinued at least 90 days prior to study enrollment and given for =< 90 days duration prior to radical prostatectomy; finasteride or dutasteride must be stopped before treatment but should not determine eligibility; for patients on prior LHRH analogs, the discontinuation date should be calculated based the expected duration of the sustained release injection, not simply the injection date of the drug

• Pathologically proven to be lymph node negative by pelvic lymphadenectomy (pN0) or lymph node status pathologically unknown (undissected pelvic lymph nodes [pNx])

• Any pT-stage based on American Joint Committee on Cancer 7th edition is acceptable for study entry based on the following diagnostic workup:

• History/physical examination within 60 days prior to step 1 registration

• No distant metastases, based upon the following minimum diagnostic workup:

• A computed tomography (CT) scan of the abdomen and/or pelvis (with contrast if renal function is acceptable; a CT without contrast is permitted if the patient is not a candidate for contrast) or magnetic resonance imaging (MRI) of the pelvis within 120 days prior to step 1 registration; lymph nodes will be non-metastatic unless they measure more than 1.5 cm short axis;

• Bone scan within 120 days prior to step 1 registration (a sodium fluoride [NaF] positron emission tomography/computed tomography [PET/CT] is an acceptable substitute); if the bone scan is suspicious, a plain x-ray, CT scan, NaF PET/CT and/or MRI must be obtained to rule out metastasis

• Eastern Cooperative Oncology Group (ECOG) performance status of =< 1 within 90 days prior to step 1 registration

• Platelets >= 1 X 10^{6 cells/mm}3 (100,000) based upon complete blood count (CBC)

• Hemoglobin >= 10.0 g/dl based upon CBC (Note: The use of transfusion or other intervention to achieve Hgb >= 10.0 g/dl is not allowed)

• Absolute neutrophil count greater than 1.5 x 10^9/L (1500)

• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 1.5 x the upper limit of normal

• Total bilirubin normal unless history of Gilbert's syndrome

• The patient or a legally authorized representative must provide study-specific informed consent prior to step 1 registration

• Available surgical formalin-fixed paraffin-embedded (FFPE) specimen for genomic analysis on DECIPHER Genomic Resource Information Database (GRID) platform

Exclusion Criteria:

• Definitive clinical or radiologic evidence of metastatic disease

• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years) Ta bladder cancer is not considered invasive

• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields

• Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable if completed more than two years prior to step 1 registration; prior androgen deprivation is allowed

• Prior whole gland ablative therapy (i.e. cryoablation or high intensity focused ultrasound [HIFU]) for prostate cancer is allowed; prior focal HIFU or treatment for benign prostatic hypertrophy is allowed

• Prostatectomy performed greater than 365 days (1 year) prior to step 1 registration

• Severe and/or active co-morbidity defined as follows:

• History of inflammatory bowel disease

• History of active hepatitis B or C; blood tests are not required to determine if the patient has had hepatitis B or C, unless the patient reports a history of hepatitis

• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months

• Transmural myocardial infarction within the last 6 months

• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 1 registration

• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization within 15 days of step 1 registration or precluding study therapy at the time of step 1 registration

• Uncontrolled severe illness or medical condition (including uncontrolled diabetes), which in the judgment of the treating physician would make the administration of chemotherapy inadvisable

• Concurrent or planned treatment with strong inhibitors (e.g. ketoconazole, clarithromycin, etcetera [etc]) or strong inducers (e.g. carbamazepine, phenytoin, rifampin, phenobarbital, efavirenz, tipranavir, St. John's wort) of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments)

• Human immunodeficiency virus (HIV) positive with cluster of differentiation 4 (CD4) count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to step 1 registration; note also that HIV testing is not required for eligibility for this protocol

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mobile Infirmary Medical Center	Mobile	Alabama	United States	36607
2	Fairbanks Memorial Hospital	Fairbanks	Alaska	United States	99701
3	Cancer Center at Saint Joseph's	Phoenix	Arizona	United States	85004
4	University of Arizona Cancer Center-Orange Grove Campus	Tucson	Arizona	United States	85704
5	Banner University Medical Center - Tucson	Tucson	Arizona	United States	85719
6	University of Arizona Cancer Center-North Campus	Tucson	Arizona	United States	85719
7	NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro	Jonesboro	Arkansas	United States	72401
8	Kaiser Permanente-Deer Valley Medical Center	Antioch	California	United States	94531
9	Adventist Health Cancer Care Center Chico	Chico	California	United States	95973
10	Kaiser Permanente Dublin	Dublin	California	United States	94568
11	Kaiser Permanente-Fremont	Fremont	California	United States	94538
12	Fresno Cancer Center	Fresno	California	United States	93720
13	Kaiser Permanente-Fresno	Fresno	California	United States	93720
14	UC San Diego Moores Cancer Center	La Jolla	California	United States	92093
15	Kaiser Permanente-Modesto	Modesto	California	United States	95356
16	Kaiser Permanente Oakland-Broadway	Oakland	California	United States	94611
17	Kaiser Permanente-Oakland	Oakland	California	United States	94611
18	Kaiser Permanente-Rancho Cordova Cancer Center	Rancho Cordova	California	United States	95670
19	Kaiser Permanente-Redwood City	Redwood City	California	United States	94063
20	Kaiser Permanente-Richmond	Richmond	California	United States	94801
21	Rohnert Park Cancer Center	Rohnert Park	California	United States	94928
22	Kaiser Permanente-Roseville	Roseville	California	United States	95661
23	Sutter Cancer Centers Radiation Oncology Services-Roseville	Roseville	California	United States	95661
24	The Permanente Medical Group-Roseville Radiation Oncology	Roseville	California	United States	95678
25	Sutter Medical Center Sacramento	Sacramento	California	United States	95816
26	Kaiser Permanente-South Sacramento	Sacramento	California	United States	95823
27	South Sacramento Cancer Center	Sacramento	California	United States	95823
28	Kaiser Permanente - Sacramento	Sacramento	California	United States	95825
29	Naval Medical Center -San Diego	San Diego	California	United States	92134
30	Kaiser Permanente-San Francisco	San Francisco	California	United States	94115
31	Kaiser Permanente-Santa Teresa-San Jose	San Jose	California	United States	95119
32	Kaiser Permanente San Leandro	San Leandro	California	United States	94577
33	Kaiser Permanente-San Rafael	San Rafael	California	United States	94903
34	Kaiser San Rafael-Gallinas	San Rafael	California	United States	94903
35	Kaiser Permanente Medical Center - Santa Clara	Santa Clara	California	United States	95051
36	Kaiser Permanente-Santa Rosa	Santa Rosa	California	United States	95403
37	Kaiser Permanente Cancer Treatment Center	South San Francisco	California	United States	94080
38	Kaiser Permanente-South San Francisco	South San Francisco	California	United States	94080
39	Kaiser Permanente-Stockton	Stockton	California	United States	95210
40	Palo Alto Medical Foundation-Sunnyvale	Sunnyvale	California	United States	94086
41	Gene Upshaw Memorial Tahoe Forest Cancer Center	Truckee	California	United States	96161
42	Kaiser Permanente Medical Center-Vacaville	Vacaville	California	United States	95688
43	Kaiser Permanente-Vallejo	Vallejo	California	United States	94589
44	Sutter Solano Medical Center/Cancer Center	Vallejo	California	United States	94589
45	Kaiser Permanente-Walnut Creek	Walnut Creek	California	United States	94596
46	University of Colorado Hospital	Aurora	Colorado	United States	80045
47	Penrose-Saint Francis Healthcare	Colorado Springs	Colorado	United States	80907
48	UCHealth Memorial Hospital Central	Colorado Springs	Colorado	United States	80909
49	Poudre Valley Hospital	Fort Collins	Colorado	United States	80524
50	Beebe South Coastal Health Campus	Frankford	Delaware	United States	19945
51	Helen F Graham Cancer Center	Newark	Delaware	United States	19713
52	Christiana Care Health System-Christiana Hospital	Newark	Delaware	United States	19718
53	Beebe Health Campus	Rehoboth Beach	Delaware	United States	19971
54	GenesisCare USA - Aventura FP	Aventura	Florida	United States	33180
55	GenesisCare USA - Aventura	Aventura	Florida	United States	33180
56	Mount Sinai Comprehensive Cancer Center at Aventura	Aventura	Florida	United States	33180
57	AdventHealth Celebration	Celebration	Florida	United States	34747
58	UM Sylvester Comprehensive Cancer Center at Coral Gables	Coral Gables	Florida	United States	33146
59	UM Sylvester Comprehensive Cancer Center at Deerfield Beach	Deerfield Beach	Florida	United States	33442
60	GenesisCare USA - Key West	Key West	Florida	United States	33040
61	AdventHealth Kissimmee	Kissimmee	Florida	United States	34744
62	Lakeland Regional Health Hollis Cancer Center	Lakeland	Florida	United States	33805
63	GenesisCare USA - Lakewood Ranch	Lakewood Ranch	Florida	United States	34202
64	Mount Sinai Medical Center	Miami Beach	Florida	United States	33140
65	University of Miami Miller School of Medicine-Sylvester Cancer Center	Miami	Florida	United States	33136
66	AdventHealth Orlando	Orlando	Florida	United States	32803
67	GenesisCare USA - Plantation	Plantation	Florida	United States	33324
68	Grady Health System	Atlanta	Georgia	United States	30303
69	Emory University Hospital Midtown	Atlanta	Georgia	United States	30308
70	Piedmont Hospital	Atlanta	Georgia	United States	30309
71	Emory University Hospital/Winship Cancer Institute	Atlanta	Georgia	United States	30322
72	Emory Saint Joseph's Hospital	Atlanta	Georgia	United States	30342
73	Piedmont Fayette Hospital	Fayetteville	Georgia	United States	30214
74	Lewis Cancer and Research Pavilion at Saint Joseph's/Candler	Savannah	Georgia	United States	31405
75	Saint Alphonsus Cancer Care Center-Boise	Boise	Idaho	United States	83706
76	Alton Memorial Hospital	Alton	Illinois	United States	62002
77	Illinois CancerCare-Bloomington	Bloomington	Illinois	United States	61704
78	Illinois CancerCare-Canton	Canton	Illinois	United States	61520
79	Illinois CancerCare-Carthage	Carthage	Illinois	United States	62321
80	Northwestern University	Chicago	Illinois	United States	60611
81	Rush University Medical Center	Chicago	Illinois	United States	60612
82	Decatur Memorial Hospital	Decatur	Illinois	United States	62526
83	Crossroads Cancer Center	Effingham	Illinois	United States	62401
84	Elmhurst Memorial Hospital	Elmhurst	Illinois	United States	60126
85	Illinois CancerCare-Eureka	Eureka	Illinois	United States	61530
86	Illinois CancerCare-Galesburg	Galesburg	Illinois	United States	61401
87	Ingalls Memorial Hospital	Harvey	Illinois	United States	60426
88	Illinois CancerCare-Kewanee Clinic	Kewanee	Illinois	United States	61443
89	Illinois CancerCare-Macomb	Macomb	Illinois	United States	61455
90	Loyola University Medical Center	Maywood	Illinois	United States	60153
91	Edward Hospital/Cancer Center	Naperville	Illinois	United States	60540
92	Illinois CancerCare-Ottawa Clinic	Ottawa	Illinois	United States	61350
93	Illinois CancerCare-Pekin	Pekin	Illinois	United States	61554
94	Illinois CancerCare-Peoria	Peoria	Illinois	United States	61615
95	OSF Saint Francis Radiation Oncology at Peoria Cancer Center	Peoria	Illinois	United States	61615
96	Methodist Medical Center of Illinois	Peoria	Illinois	United States	61636
97	OSF Saint Francis Medical Center	Peoria	Illinois	United States	61637
98	Illinois CancerCare-Peru	Peru	Illinois	United States	61354
99	Edward Hospital/Cancer Center?Plainfield	Plainfield	Illinois	United States	60585
100	Illinois CancerCare-Princeton	Princeton	Illinois	United States	61356
101	Parkview Hospital Randallia	Fort Wayne	Indiana	United States	46805
102	Parkview Regional Medical Center	Fort Wayne	Indiana	United States	46845
103	Goshen Center for Cancer Care	Goshen	Indiana	United States	46526
104	Indiana University/Melvin and Bren Simon Cancer Center	Indianapolis	Indiana	United States	46202
105	Reid Health	Richmond	Indiana	United States	47374
106	McFarland Clinic PC - Ames	Ames	Iowa	United States	50010
107	Mercy Hospital	Cedar Rapids	Iowa	United States	52403
108	University of Kansas Cancer Center	Kansas City	Kansas	United States	66160
109	Olathe Health Cancer Center	Olathe	Kansas	United States	66061
110	University of Kansas Cancer Center-Overland Park	Overland Park	Kansas	United States	66210
111	Cotton O'Neil Cancer Center / Stormont Vail Health	Topeka	Kansas	United States	66606
112	Ascension Via Christi Hospitals Wichita	Wichita	Kansas	United States	67214
113	East Jefferson General Hospital	Metairie	Louisiana	United States	70006
114	LSU Healthcare Network / Metairie Multi-Specialty Clinic	Metairie	Louisiana	United States	70006
115	Ochsner Medical Center Jefferson	New Orleans	Louisiana	United States	70121
116	University of Maryland/Greenebaum Cancer Center	Baltimore	Maryland	United States	21201
117	Central Maryland Radiation Oncology in Howard County	Columbia	Maryland	United States	21044
118	UM Baltimore Washington Medical Center/Tate Cancer Center	Glen Burnie	Maryland	United States	21061
119	TidalHealth Richard A Henson Cancer Institute	Ocean Pines	Maryland	United States	21811
120	TidalHealth Peninsula Regional	Salisbury	Maryland	United States	21801
121	Boston Medical Center	Boston	Massachusetts	United States	02118
122	Lahey Hospital and Medical Center	Burlington	Massachusetts	United States	01805
123	Lahey Medical Center-Peabody	Peabody	Massachusetts	United States	01960
124	Winchester Hospital	Winchester	Massachusetts	United States	01890
125	Saint Joseph Mercy Hospital	Ann Arbor	Michigan	United States	48106
126	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109
127	Henry Ford Cancer Institute-Downriver	Brownstown	Michigan	United States	48183
128	GenesisCare USA - Clarkston	Clarkston	Michigan	United States	48346
129	McLaren Cancer Institute-Clarkston	Clarkston	Michigan	United States	48346
130	Henry Ford Macomb Hospital-Clinton Township	Clinton Township	Michigan	United States	48038
131	Beaumont Hospital - Dearborn	Dearborn	Michigan	United States	48124
132	Wayne State University/Karmanos Cancer Institute	Detroit	Michigan	United States	48201
133	Henry Ford Hospital	Detroit	Michigan	United States	48202
134	Ascension Saint John Hospital	Detroit	Michigan	United States	48236
135	GenesisCare USA - Farmington Hills	Farmington Hills	Michigan	United States	48334
136	Weisberg Cancer Treatment Center	Farmington Hills	Michigan	United States	48334
137	McLaren Cancer Institute-Flint	Flint	Michigan	United States	48532
138	Spectrum Health at Butterworth Campus	Grand Rapids	Michigan	United States	49503
139	Allegiance Health	Jackson	Michigan	United States	49201
140	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007
141	Karmanos Cancer Institute at McLaren Greater Lansing	Lansing	Michigan	United States	48910
142	Mid-Michigan Physicians-Lansing	Lansing	Michigan	United States	48912
143	Sparrow Hospital	Lansing	Michigan	United States	48912
144	McLaren Cancer Institute-Lapeer Region	Lapeer	Michigan	United States	48446
145	Trinity Health Saint Mary Mercy Livonia Hospital	Livonia	Michigan	United States	48154
146	GenesisCare USA - Macomb	Macomb	Michigan	United States	48044
147	GenesisCare USA - Madison Heights	Madison Heights	Michigan	United States	48071
148	McLaren Cancer Institute-Macomb	Mount Clemens	Michigan	United States	48043
149	McLaren Cancer Institute-Central Michigan	Mount Pleasant	Michigan	United States	48858
150	McLaren Cancer Institute-Northern Michigan	Petoskey	Michigan	United States	49770
151	21st Century Oncology-Pontiac	Pontiac	Michigan	United States	48341
152	Saint Joseph Mercy Oakland	Pontiac	Michigan	United States	48341
153	McLaren-Port Huron	Port Huron	Michigan	United States	48060
154	William Beaumont Hospital-Royal Oak	Royal Oak	Michigan	United States	48073
155	Ascension Saint Mary's Hospital	Saginaw	Michigan	United States	48601
156	William Beaumont Hospital - Troy	Troy	Michigan	United States	48085
157	GenesisCare USA - Troy	Troy	Michigan	United States	48098
158	Saint John Macomb-Oakland Hospital	Warren	Michigan	United States	48093
159	Henry Ford West Bloomfield Hospital	West Bloomfield	Michigan	United States	48322
160	Metro Health Hospital	Wyoming	Michigan	United States	49519
161	Mayo Clinic Health System in Albert Lea	Albert Lea	Minnesota	United States	56007
162	Sanford Joe Lueken Cancer Center	Bemidji	Minnesota	United States	56601
163	Saint Luke's Hospital of Duluth	Duluth	Minnesota	United States	55805
164	Fairview Southdale Hospital	Edina	Minnesota	United States	55435
165	Mayo Clinic Health Systems-Mankato	Mankato	Minnesota	United States	56001
166	Hennepin County Medical Center	Minneapolis	Minnesota	United States	55415
167	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905
168	Coborn Cancer Center at Saint Cloud Hospital	Saint Cloud	Minnesota	United States	56303
169	Park Nicollet Clinic - Saint Louis Park	Saint Louis Park	Minnesota	United States	55416
170	Regions Hospital	Saint Paul	Minnesota	United States	55101
171	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
172	Saint Francis Medical Center	Cape Girardeau	Missouri	United States	63703
173	The University of Kansas Cancer Center-South	Kansas City	Missouri	United States	64131
174	University of Kansas Cancer Center - North	Kansas City	Missouri	United States	64154
175	University of Kansas Cancer Center - Lee's Summit	Lee's Summit	Missouri	United States	64064
176	Delbert Day Cancer Institute at PCRMC	Rolla	Missouri	United States	65401
177	Heartland Regional Medical Center	Saint Joseph	Missouri	United States	64506
178	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
179	Siteman Cancer Center-South County	Saint Louis	Missouri	United States	63129
180	Siteman Cancer Center at Christian Hospital	Saint Louis	Missouri	United States	63136
181	Mercy Hospital Saint Louis	Saint Louis	Missouri	United States	63141
182	Siteman Cancer Center at Saint Peters Hospital	Saint Peters	Missouri	United States	63376
183	Mercy Hospital Springfield	Springfield	Missouri	United States	65804
184	Billings Clinic Cancer Center	Billings	Montana	United States	59101
185	Bozeman Deaconess Hospital	Bozeman	Montana	United States	59715
186	Benefis Healthcare- Sletten Cancer Institute	Great Falls	Montana	United States	59405
187	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
188	Nebraska Methodist Hospital	Omaha	Nebraska	United States	68114
189	Radiation Oncology Centers of Nevada Central	Las Vegas	Nevada	United States	89106
190	Radiation Oncology Centers of Nevada Southeast	Las Vegas	Nevada	United States	89119
191	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
192	AtlantiCare Health Park-Cape May Court House	Cape May Court House	New Jersey	United States	08210
193	AtlantiCare Surgery Center	Egg Harbor Township	New Jersey	United States	08234
194	Robert Wood Johnson University Hospital Somerset	Somerville	New Jersey	United States	08876
195	New York-Presbyterian/Brooklyn Methodist Hospital	Brooklyn	New York	United States	11215
196	Roswell Park Cancer Institute	Buffalo	New York	United States	14263
197	Highland Hospital	Rochester	New York	United States	14620
198	University of Rochester	Rochester	New York	United States	14642
199	Stony Brook University Medical Center	Stony Brook	New York	United States	11794
200	Dickstein Cancer Treatment Center	White Plains	New York	United States	10601
201	Duke University Medical Center	Durham	North Carolina	United States	27710
202	Cone Health Cancer Center	Greensboro	North Carolina	United States	27403
203	Margaret R Pardee Memorial Hospital	Hendersonville	North Carolina	United States	28791
204	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157
205	Sanford Bismarck Medical Center	Bismarck	North Dakota	United States	58501
206	Sanford Roger Maris Cancer Center	Fargo	North Dakota	United States	58122
207	UHHS-Chagrin Highlands Medical Center	Beachwood	Ohio	United States	44122
208	Geauga Hospital	Chardon	Ohio	United States	44024
209	Case Western Reserve University	Cleveland	Ohio	United States	44106
210	Ohio State University Comprehensive Cancer Center	Columbus	Ohio	United States	43210
211	Miami Valley Hospital North	Dayton	Ohio	United States	45415
212	Mercy Cancer Center-Elyria	Elyria	Ohio	United States	44035
213	Atrium Medical Center-Middletown Regional Hospital	Franklin	Ohio	United States	45005-1066
214	UH Seidman Cancer Center at Lake Health Mentor Campus	Mentor	Ohio	United States	44060
215	UH Seidman Cancer Center at Southwest General Hospital	Middleburg Heights	Ohio	United States	44130
216	University Hospitals Parma Medical Center	Parma	Ohio	United States	44129
217	University Hospitals Portage Medical Center	Ravenna	Ohio	United States	44266
218	UH Seidman Cancer Center at Firelands Regional Medical Center	Sandusky	Ohio	United States	44870
219	Springfield Regional Cancer Center	Springfield	Ohio	United States	45504
220	ProMedica Flower Hospital	Sylvania	Ohio	United States	43560
221	University of Toledo	Toledo	Ohio	United States	43614
222	UHHS-Westlake Medical Center	Westlake	Ohio	United States	44145
223	Cancer Centers of Southwest Oklahoma Research	Lawton	Oklahoma	United States	73505
224	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104
225	Clackamas Radiation Oncology Center	Clackamas	Oregon	United States	97015
226	Providence Portland Medical Center	Portland	Oregon	United States	97213
227	Providence Saint Vincent Medical Center	Portland	Oregon	United States	97225
228	Jefferson Abington Hospital	Abington	Pennsylvania	United States	19001
229	Crozer-Keystone Regional Cancer Center at Broomall	Broomall	Pennsylvania	United States	19008
230	Christiana Care Health System-Concord Health Center	Chadds Ford	Pennsylvania	United States	19317
231	Geisinger Medical Center	Danville	Pennsylvania	United States	17822
232	Northeast Radiation Oncology Center	Dunmore	Pennsylvania	United States	18512
233	Saint Vincent Hospital	Erie	Pennsylvania	United States	16544
234	Crozer Regional Cancer Center at Brinton Lake	Glen Mills	Pennsylvania	United States	19342
235	UPMC Pinnacle Cancer Center/Community Osteopathic Campus	Harrisburg	Pennsylvania	United States	17109
236	Jefferson Hospital	Jefferson Hills	Pennsylvania	United States	15025
237	Saint Mary Medical and Regional Cancer Center	Langhorne	Pennsylvania	United States	19047
238	Geisinger Medical Oncology-Lewisburg	Lewisburg	Pennsylvania	United States	17837
239	Lewistown Hospital	Lewistown	Pennsylvania	United States	17044
240	Forbes Hospital	Monroeville	Pennsylvania	United States	15146
241	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	United States	19107
242	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
243	Jefferson Torresdale Hospital	Philadelphia	Pennsylvania	United States	19114
244	Temple University Hospital	Philadelphia	Pennsylvania	United States	19140
245	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212
246	Penn State Health Saint Joseph Medical Center	Reading	Pennsylvania	United States	19605
247	Reading Hospital	West Reading	Pennsylvania	United States	19611
248	Wexford Health and Wellness Pavilion	Wexford	Pennsylvania	United States	15090
249	Geisinger Wyoming Valley/Henry Cancer Center	Wilkes-Barre	Pennsylvania	United States	18711
250	Asplundh Cancer Pavilion	Willow Grove	Pennsylvania	United States	19090
251	Prisma Health Cancer Institute - Spartanburg	Boiling Springs	South Carolina	United States	29316
252	Medical University of South Carolina	Charleston	South Carolina	United States	29425
253	Prisma Health Cancer Institute - Faris	Greenville	South Carolina	United States	29605
254	Saint Francis Cancer Center	Greenville	South Carolina	United States	29607
255	Prisma Health Cancer Institute - Eastside	Greenville	South Carolina	United States	29615
256	Self Regional Healthcare	Greenwood	South Carolina	United States	29646
257	Prisma Health Cancer Institute - Greer	Greer	South Carolina	United States	29650
258	Gibbs Cancer Center-Pelham	Greer	South Carolina	United States	29651
259	The Radiation Oncology Center-Hilton Head/Bluffton	Hilton Head Island	South Carolina	United States	29926
260	Carolina Regional Cancer Center	Myrtle Beach	South Carolina	United States	29577
261	Prisma Health Cancer Institute - Seneca	Seneca	South Carolina	United States	29672
262	Spartanburg Medical Center	Spartanburg	South Carolina	United States	29303
263	Avera Cancer Institute	Sioux Falls	South Dakota	United States	57105
264	Sanford USD Medical Center - Sioux Falls	Sioux Falls	South Dakota	United States	57117-5134
265	UT Southwestern/Simmons Cancer Center-Dallas	Dallas	Texas	United States	75390
266	University of Texas Medical Branch	Galveston	Texas	United States	77555-0565
267	UTMB Cancer Center at Victory Lakes	League City	Texas	United States	77573
268	Sandra L Maxwell Cancer Center	Cedar City	Utah	United States	84720
269	Logan Regional Hospital	Logan	Utah	United States	84321
270	Intermountain Medical Center	Murray	Utah	United States	84107
271	McKay-Dee Hospital Center	Ogden	Utah	United States	84403
272	Saint George Regional Medical Center	Saint George	Utah	United States	84770
273	Utah Cancer Specialists-Salt Lake City	Salt Lake City	Utah	United States	84106
274	LDS Hospital	Salt Lake City	Utah	United States	84143
275	Southwestern Vermont Medical Center	Bennington	Vermont	United States	05201
276	Norris Cotton Cancer Center-North	Saint Johnsbury	Vermont	United States	05819
277	University of Virginia Cancer Center	Charlottesville	Virginia	United States	22908
278	MultiCare Auburn Medical Center	Auburn	Washington	United States	98001
279	West Virginia University Charleston Division	Charleston	West Virginia	United States	25304
280	West Virginia University Healthcare	Morgantown	West Virginia	United States	26506
281	Camden Clark Medical Center	Parkersburg	West Virginia	United States	26101
282	Langlade Hospital and Cancer Center	Antigo	Wisconsin	United States	54409
283	ThedaCare Regional Cancer Center	Appleton	Wisconsin	United States	54911
284	Marshfield Medical Center-EC Cancer Center	Eau Claire	Wisconsin	United States	54701
285	Aurora Cancer Care-Grafton	Grafton	Wisconsin	United States	53024
286	Aurora BayCare Medical Center	Green Bay	Wisconsin	United States	54311
287	UW Cancer Center Johnson Creek	Johnson Creek	Wisconsin	United States	53038
288	Aurora Cancer Care-Kenosha South	Kenosha	Wisconsin	United States	53142
289	Aurora Bay Area Medical Group-Marinette	Marinette	Wisconsin	United States	54143
290	Marshfield Medical Center-Marshfield	Marshfield	Wisconsin	United States	54449
291	Froedtert Menomonee Falls Hospital	Menomonee Falls	Wisconsin	United States	53051
292	Ascension Columbia Saint Mary's Hospital Ozaukee	Mequon	Wisconsin	United States	53097
293	Ascension Columbia Saint Mary's Hospital - Milwaukee	Milwaukee	Wisconsin	United States	53211
294	Aurora Saint Luke's Medical Center	Milwaukee	Wisconsin	United States	53215
295	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
296	Aurora Sinai Medical Center	Milwaukee	Wisconsin	United States	53233
297	Zablocki Veterans Administration Medical Center	Milwaukee	Wisconsin	United States	53295
298	Marshfield Clinic-Minocqua Center	Minocqua	Wisconsin	United States	54548
299	Drexel Town Square Health Center	Oak Creek	Wisconsin	United States	53154
300	Vince Lombardi Cancer Clinic - Oshkosh	Oshkosh	Wisconsin	United States	54904
301	Marshfield Medical Center-Rice Lake	Rice Lake	Wisconsin	United States	54868
302	Vince Lombardi Cancer Clinic-Sheboygan	Sheboygan	Wisconsin	United States	53081
303	Marshfield Medical Center-River Region at Stevens Point	Stevens Point	Wisconsin	United States	54482
304	Aurora Medical Center in Summit	Summit	Wisconsin	United States	53066
305	Vince Lombardi Cancer Clinic-Two Rivers	Two Rivers	Wisconsin	United States	54241
306	Aspirus Regional Cancer Center	Wausau	Wisconsin	United States	54401
307	Aurora Cancer Care-Milwaukee West	Wauwatosa	Wisconsin	United States	53226
308	Aurora West Allis Medical Center	West Allis	Wisconsin	United States	53227
309	Froedtert West Bend Hospital/Kraemer Cancer Center	West Bend	Wisconsin	United States	53095
310	Diagnostic and Treatment Center	Weston	Wisconsin	United States	54476
311	Marshfield Medical Center - Weston	Weston	Wisconsin	United States	54476
312	Aspirus Cancer Care - Wisconsin Rapids	Wisconsin Rapids	Wisconsin	United States	54494
313	Tom Baker Cancer Centre	Calgary	Alberta	Canada	T2N 4N2
314	Centro Comprensivo de Cancer de UPR	San Juan		Puerto Rico	00927

Sponsors and Collaborators

• NRG Oncology
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Mark Hurwitz, MD, NRG Oncology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NRG Oncology
• ClinicalTrials.gov Identifier: NCT03070886
• Other Study ID Numbers: NRG-GU002; NCI-2016-00963; NRG-GU002; NRG-GU002; U10CA180868
• First Posted: Mar 6, 2017
• Last Update Posted: Aug 12, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Adenocarcinoma; Prostatic Neoplasms; Docetaxel; Leuprolide; Goserelin; Bicalutamide; Flutamide; Nilutamide

Study Results

No Results Posted as of Aug 12, 2022