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

Sponsor
Southwest Oncology Group (Other)
Overall Status
Recruiting
CT.gov ID
NCT03678025
Collaborator
National Cancer Institute (NCI) (NIH)
1,273
Enrollment
302
Locations
3
Arms
156.5
Anticipated Duration (Months)
4.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

PRIMARY OBJECTIVES:
  1. 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:

  1. 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.

  2. To compare the rate of symptomatic local progression between the treatment arms.

  3. 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:
  1. 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:
  1. 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.

  1. 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.

  2. Participants receive degarelix via injection for 2 doses and then every 28 days.

  3. 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.

  4. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1273 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer
Actual Study Start Date :
Sep 17, 2018
Anticipated Primary Completion Date :
Apr 1, 2028
Anticipated Study Completion Date :
Oct 1, 2031

Arms and Interventions

Arm Intervention/Treatment
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival (OS) [From date of randomization to date of death due to any cause, assessed up to 8 years]

    Secondary Outcome Measures

    1. Media OS [From date of randomization to date of death due to any cause, assessed up to 8 years]

      Will compare OS in metastatic prostate cancer patients who received standard systemic therapy (SST) plus surgical excision of the primary tumor versus SST alone in the subset who specify the surgical intent stratification factor.

    2. Rate of symptomatic local progression [Up to 8 years]

      Defined as any of the following events post-randomization: Common Terminology Criteria for Adverse Events version 5 grade >= 2 hematuria, urinary retention, urinary tract obstruction, urinary tract pain, pelvic pain, renal and urinary disorders-other. Will be compared between the treatment arms. A proportional hazards model will be fit to each of these endpoints where the time interval starts at date of randomization to (i) time of first symptomatic local progression or ii) progression or death due to any cause, where those without the event are censored at their last contact date. Stratification factors will be adjusted for as covariates.

    3. Progression-free survival (PFS) [From date of randomization to date of first documentation of progression, or death due to any cause, assessed up to 8 years]

      Will be compared between for the subsets of patients with and without metastasis directed therapy (MDT) to oligometastatic sites. A proportional hazards model will be fit to each of these endpoints where the time interval starts at date of randomization to (i) time of first symptomatic local progression or ii) progression or death due to any cause, where those without the event are censored at their last contact date. Stratification factors will be adjusted for as covariates.

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Banner MD Anderson Cancer Center Gilbert Arizona United States 85234
    2 Mayo Clinic Hospital in Arizona Phoenix Arizona United States 85054
    3 Mayo Clinic in Arizona Scottsdale Arizona United States 85259
    4 University of Arizona Cancer Center-Orange Grove Campus Tucson Arizona United States 85704
    5 University of Arizona Cancer Center-North Campus Tucson Arizona United States 85719
    6 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    7 Kaiser Permanente-Deer Valley Medical Center Antioch California United States 94531
    8 Community Cancer Institute Clovis California United States 93611
    9 University Oncology Associates Clovis California United States 93611
    10 City of Hope Comprehensive Cancer Center Duarte California United States 91010
    11 Kaiser Permanente Dublin Dublin California United States 94568
    12 Kaiser Permanente-Fremont Fremont California United States 94538
    13 Fresno Cancer Center Fresno California United States 93720
    14 Kaiser Permanente-Fresno Fresno California United States 93720
    15 UC San Diego Moores Cancer Center La Jolla California United States 92093
    16 Tibor Rubin VA Medical Center Long Beach California United States 90822
    17 Los Angeles County-USC Medical Center Los Angeles California United States 90033
    18 USC / Norris Comprehensive Cancer Center Los Angeles California United States 90033
    19 Fremont - Rideout Cancer Center Marysville California United States 95901
    20 Kaiser Permanente-Modesto Modesto California United States 95356
    21 Kaiser Permanente Oakland-Broadway Oakland California United States 94611
    22 Kaiser Permanente-Oakland Oakland California United States 94611
    23 Desert Regional Medical Center Palm Springs California United States 92262
    24 Stanford Cancer Institute Palo Alto Palo Alto California United States 94304
    25 Kaiser Permanente-Rancho Cordova Cancer Center Rancho Cordova California United States 95670
    26 Kaiser Permanente-Redwood City Redwood City California United States 94063
    27 Kaiser Permanente-Richmond Richmond California United States 94801
    28 Rohnert Park Cancer Center Rohnert Park California United States 94928
    29 Kaiser Permanente-Roseville Roseville California United States 95661
    30 The Permanente Medical Group-Roseville Radiation Oncology Roseville California United States 95678
    31 Kaiser Permanente Downtown Commons Sacramento California United States 95814
    32 University of California Davis Comprehensive Cancer Center Sacramento California United States 95817
    33 Kaiser Permanente-South Sacramento Sacramento California United States 95823
    34 South Sacramento Cancer Center Sacramento California United States 95823
    35 Kaiser Permanente-San Francisco San Francisco California United States 94115
    36 Kaiser Permanente-Santa Teresa-San Jose San Jose California United States 95119
    37 Kaiser Permanente San Leandro San Leandro California United States 94577
    38 Kaiser San Rafael-Gallinas San Rafael California United States 94903
    39 Kaiser Permanente Medical Center - Santa Clara Santa Clara California United States 95051
    40 Kaiser Permanente-Santa Rosa Santa Rosa California United States 95403
    41 Kaiser Permanente Cancer Treatment Center South San Francisco California United States 94080
    42 Kaiser Permanente-South San Francisco South San Francisco California United States 94080
    43 Kaiser Permanente-Stockton Stockton California United States 95210
    44 Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee California United States 96161
    45 Kaiser Permanente Medical Center-Vacaville Vacaville California United States 95688
    46 Kaiser Permanente-Vallejo Vallejo California United States 94589
    47 Kaiser Permanente-Walnut Creek Walnut Creek California United States 94596
    48 University of Colorado Hospital Aurora Colorado United States 80045
    49 Rocky Mountain Cancer Centers-Boulder Boulder Colorado United States 80304
    50 UCHealth Memorial Hospital Central Colorado Springs Colorado United States 80909
    51 Memorial Hospital North Colorado Springs Colorado United States 80920
    52 Porter Adventist Hospital Denver Colorado United States 80210
    53 Shaw Cancer Center Edwards Colorado United States 81632
    54 Poudre Valley Hospital Fort Collins Colorado United States 80524
    55 Littleton Adventist Hospital Littleton Colorado United States 80122
    56 Parker Adventist Hospital Parker Colorado United States 80138
    57 Yale University New Haven Connecticut United States 06520
    58 Stamford Hospital/Bennett Cancer Center Stamford Connecticut United States 06904
    59 Veterans Affairs Connecticut Healthcare System-West Haven Campus West Haven Connecticut United States 06516
    60 Helen F Graham Cancer Center Newark Delaware United States 19713
    61 Christiana Care Health System-Christiana Hospital Newark Delaware United States 19718
    62 MedStar Georgetown University Hospital Washington District of Columbia United States 20007
    63 MedStar Washington Hospital Center Washington District of Columbia United States 20010
    64 George Washington University Medical Center Washington District of Columbia United States 20037
    65 UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables Florida United States 33146
    66 UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach Florida United States 33442
    67 Baptist MD Anderson Cancer Center Jacksonville Florida United States 32207
    68 University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida United States 33136
    69 UM Sylvester Comprehensive Cancer Center at Kendall Miami Florida United States 33176
    70 Orlando Health Cancer Institute Orlando Florida United States 32806
    71 UM Sylvester Comprehensive Cancer Center at Plantation Plantation Florida United States 33324
    72 Grady Health System Atlanta Georgia United States 30303
    73 Emory University Hospital Midtown Atlanta Georgia United States 30308
    74 Emory University Hospital/Winship Cancer Institute Atlanta Georgia United States 30322
    75 Emory Saint Joseph's Hospital Atlanta Georgia United States 30342
    76 Augusta University Medical Center Augusta Georgia United States 30912
    77 Atlanta VA Medical Center Decatur Georgia United States 30033
    78 Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho United States 83605
    79 Saint Alphonsus Medical Center-Nampa Nampa Idaho United States 83686
    80 Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho United States 83854
    81 Rush - Copley Medical Center Aurora Illinois United States 60504
    82 Illinois CancerCare-Bloomington Bloomington Illinois United States 61704
    83 Illinois CancerCare-Canton Canton Illinois United States 61520
    84 Illinois CancerCare-Carthage Carthage Illinois United States 62321
    85 Northwestern University Chicago Illinois United States 60611
    86 Rush University Medical Center Chicago Illinois United States 60612
    87 University of Illinois Chicago Illinois United States 60612
    88 University of Chicago Comprehensive Cancer Center Chicago Illinois United States 60637
    89 Decatur Memorial Hospital Decatur Illinois United States 62526
    90 Crossroads Cancer Center Effingham Illinois United States 62401
    91 Illinois CancerCare-Eureka Eureka Illinois United States 61530
    92 Illinois CancerCare-Galesburg Galesburg Illinois United States 61401
    93 Illinois CancerCare-Kewanee Clinic Kewanee Illinois United States 61443
    94 Illinois CancerCare-Macomb Macomb Illinois United States 61455
    95 Loyola University Medical Center Maywood Illinois United States 60153
    96 Illinois CancerCare-Ottawa Clinic Ottawa Illinois United States 61350
    97 Illinois CancerCare-Pekin Pekin Illinois United States 61554
    98 Illinois CancerCare-Peoria Peoria Illinois United States 61615
    99 Methodist Medical Center of Illinois Peoria Illinois United States 61636
    100 OSF Saint Francis Medical Center Peoria Illinois United States 61637
    101 Illinois CancerCare-Peru Peru Illinois United States 61354
    102 Illinois CancerCare-Princeton Princeton Illinois United States 61356
    103 Southwest Illinois Health Services LLP Swansea Illinois United States 62226
    104 Carle Cancer Center Urbana Illinois United States 61801
    105 Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana United States 46202
    106 Reid Health Richmond Indiana United States 47374
    107 McFarland Clinic PC - Ames Ames Iowa United States 50010
    108 University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa United States 52242
    109 University of Kansas Cancer Center Kansas City Kansas United States 66160
    110 Olathe Health Cancer Center Olathe Kansas United States 66061
    111 University of Kansas Cancer Center-Overland Park Overland Park Kansas United States 66210
    112 University of Kansas Hospital-Westwood Cancer Center Westwood Kansas United States 66205
    113 Saint Joseph Radiation Oncology Resource Center Lexington Kentucky United States 40504
    114 Saint Joseph Hospital East Lexington Kentucky United States 40509
    115 The James Graham Brown Cancer Center at University of Louisville Louisville Kentucky United States 40202
    116 East Jefferson General Hospital Metairie Louisiana United States 70006
    117 LSU Healthcare Network / Metairie Multi-Specialty Clinic Metairie Louisiana United States 70006
    118 MaineHealth Coastal Cancer Treatment Center Bath Maine United States 04530
    119 Lafayette Family Cancer Center-EMMC Brewer Maine United States 04412
    120 Maine Medical Center-Bramhall Campus Portland Maine United States 04102
    121 MaineHealth Cancer Care Center of York County Sanford Maine United States 04073
    122 MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford Sanford Maine United States 04073
    123 Maine Medical Center- Scarborough Campus Scarborough Maine United States 04074
    124 Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland United States 21287
    125 Lahey Hospital and Medical Center Burlington Massachusetts United States 01805
    126 Saint Joseph Mercy Hospital Ann Arbor Michigan United States 48106
    127 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109
    128 Saint Joseph Mercy Brighton Brighton Michigan United States 48114
    129 Henry Ford Cancer Institute-Downriver Brownstown Michigan United States 48183
    130 Saint Joseph Mercy Canton Canton Michigan United States 48188
    131 Saint Joseph Mercy Chelsea Chelsea Michigan United States 48118
    132 GenesisCare USA - Clarkston Clarkston Michigan United States 48346
    133 Henry Ford Macomb Hospital-Clinton Township Clinton Township Michigan United States 48038
    134 Wayne State University/Karmanos Cancer Institute Detroit Michigan United States 48201
    135 Henry Ford Hospital Detroit Michigan United States 48202
    136 GenesisCare USA - Farmington Hills Farmington Hills Michigan United States 48334
    137 Spectrum Health at Butterworth Campus Grand Rapids Michigan United States 49503
    138 West Michigan Cancer Center Kalamazoo Michigan United States 49007
    139 Sparrow Hospital Lansing Michigan United States 48912
    140 GenesisCare USA - Macomb Macomb Michigan United States 48044
    141 GenesisCare USA - Madison Heights Madison Heights Michigan United States 48071
    142 Ascension Saint Mary's Hospital Saginaw Michigan United States 48601
    143 Munson Medical Center Traverse City Michigan United States 49684
    144 GenesisCare USA - Troy Troy Michigan United States 48098
    145 Henry Ford West Bloomfield Hospital West Bloomfield Michigan United States 48322
    146 Mercy Hospital Coon Rapids Minnesota United States 55433
    147 Fairview Southdale Hospital Edina Minnesota United States 55435
    148 Unity Hospital Fridley Minnesota United States 55432
    149 Hennepin County Medical Center Minneapolis Minnesota United States 55415
    150 Health Partners Inc Minneapolis Minnesota United States 55454
    151 North Memorial Medical Health Center Robbinsdale Minnesota United States 55422
    152 Mayo Clinic in Rochester Rochester Minnesota United States 55905
    153 Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota United States 55416
    154 Regions Hospital Saint Paul Minnesota United States 55101
    155 Saint Francis Regional Medical Center Shakopee Minnesota United States 55379
    156 University of Mississippi Medical Center Jackson Mississippi United States 39216
    157 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
    158 Southeast Cancer Center Cape Girardeau Missouri United States 63703
    159 University of Missouri - Ellis Fischel Columbia Missouri United States 65212
    160 Siteman Cancer Center at West County Hospital Creve Coeur Missouri United States 63141
    161 Freeman Health System Joplin Missouri United States 64804
    162 University of Kansas Cancer Center - North Kansas City Missouri United States 64154
    163 Washington University School of Medicine Saint Louis Missouri United States 63110
    164 Siteman Cancer Center-South County Saint Louis Missouri United States 63129
    165 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
    166 Siteman Cancer Center at Christian Hospital Saint Louis Missouri United States 63136
    167 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
    168 Siteman Cancer Center at Saint Peters Hospital Saint Peters Missouri United States 63376
    169 Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri United States 63670
    170 Mercy Hospital Springfield Springfield Missouri United States 65804
    171 Billings Clinic Cancer Center Billings Montana United States 59101
    172 Bozeman Deaconess Hospital Bozeman Montana United States 59715
    173 Saint James Community Hospital and Cancer Treatment Center Butte Montana United States 59701
    174 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
    175 Kalispell Regional Medical Center Kalispell Montana United States 59901
    176 Nebraska Methodist Hospital Omaha Nebraska United States 68114
    177 University of Nebraska Medical Center Omaha Nebraska United States 68198
    178 Comprehensive Cancer Centers of Nevada - Henderson Henderson Nevada United States 89052
    179 Radiation Oncology Centers of Nevada Central Las Vegas Nevada United States 89106
    180 Comprehensive Cancer Centers of Nevada - Northwest Las Vegas Nevada United States 89128
    181 Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas Nevada United States 89144
    182 Comprehensive Cancer Centers of Nevada Las Vegas Nevada United States 89148
    183 Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas Nevada United States 89169
    184 New Hampshire Oncology Hematology PA-Concord Concord New Hampshire United States 03301
    185 Wentworth-Douglass Hospital Dover New Hampshire United States 03820
    186 Elliot Hospital Manchester New Hampshire United States 03103
    187 Solinsky Center for Cancer Care Manchester New Hampshire United States 03103
    188 Hackensack University Medical Center Hackensack New Jersey United States 07601
    189 Holy Name Hospital Teaneck New Jersey United States 07666
    190 Montefiore Medical Center-Einstein Campus Bronx New York United States 10461
    191 Montefiore Medical Center - Moses Campus Bronx New York United States 10467
    192 James J Peters VA Medical Center Bronx New York United States 10468
    193 Roswell Park Cancer Institute Buffalo New York United States 14263
    194 Noyes Memorial Hospital/Myers Cancer Center Dansville New York United States 14437
    195 Glens Falls Hospital Glens Falls New York United States 12801
    196 Northwell Health/Center for Advanced Medicine Lake Success New York United States 11042
    197 NYP/Weill Cornell Medical Center New York New York United States 10065
    198 Upstate Cancer Center Radiation Oncology at Oneida Oneida New York United States 13421
    199 Upstate Cancer Center Radiation Oncology at Oswego Oswego New York United States 13126
    200 Highland Hospital Rochester New York United States 14620
    201 University of Rochester Rochester New York United States 14642
    202 Stony Brook University Medical Center Stony Brook New York United States 11794
    203 State University of New York Upstate Medical University Syracuse New York United States 13210
    204 Atrium Health Stanly/LCI-Albemarle Albemarle North Carolina United States 28002
    205 Mission Hospital Asheville North Carolina United States 28801
    206 Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina United States 28203
    207 Atrium Health Pineville/LCI-Pineville Charlotte North Carolina United States 28210
    208 Atrium Health Cabarrus/LCI-Concord Concord North Carolina United States 28025
    209 Margaret R Pardee Memorial Hospital Hendersonville North Carolina United States 28791
    210 Atrium Health Union/LCI-Union Monroe North Carolina United States 28112
    211 CarolinaEast Medical Center New Bern North Carolina United States 28561
    212 Cleveland Clinic Mercy Hospital Canton Ohio United States 44708
    213 Miami Valley Hospital South Centerville Ohio United States 45459
    214 University of Cincinnati Cancer Center-UC Medical Center Cincinnati Ohio United States 45219
    215 MetroHealth Medical Center Cleveland Ohio United States 44109
    216 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210
    217 Miami Valley Hospital North Dayton Ohio United States 45415
    218 Greater Dayton Cancer Center Kettering Ohio United States 45409
    219 Kettering Medical Center Kettering Ohio United States 45429
    220 University of Cincinnati Cancer Center-West Chester West Chester Ohio United States 45069
    221 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    222 Legacy Mount Hood Medical Center Gresham Oregon United States 97030
    223 Legacy Good Samaritan Hospital and Medical Center Portland Oregon United States 97210
    224 Oregon Health and Science University Portland Oregon United States 97239
    225 Geisinger Medical Center Danville Pennsylvania United States 17822
    226 Ephrata Cancer Center Ephrata Pennsylvania United States 17522
    227 Adams Cancer Center Gettysburg Pennsylvania United States 17325
    228 Sechler Family Cancer Center Lebanon Pennsylvania United States 17042
    229 Geisinger Medical Oncology-Lewisburg Lewisburg Pennsylvania United States 17837
    230 Temple University Hospital Philadelphia Pennsylvania United States 19140
    231 University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania United States 15232
    232 UPMC-Shadyside Hospital Pittsburgh Pennsylvania United States 15232
    233 Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania United States 18711
    234 WellSpan Health-York Cancer Center York Pennsylvania United States 17403
    235 Prisma Health Cancer Institute - Spartanburg Boiling Springs South Carolina United States 29316
    236 Medical University of South Carolina Charleston South Carolina United States 29425
    237 Prisma Health Cancer Institute - Faris Greenville South Carolina United States 29605
    238 Saint Francis Cancer Center Greenville South Carolina United States 29607
    239 Prisma Health Cancer Institute - Eastside Greenville South Carolina United States 29615
    240 Prisma Health Cancer Institute - Greer Greer South Carolina United States 29650
    241 Rock Hill Radiation Therapy Center Rock Hill South Carolina United States 29730
    242 Prisma Health Cancer Institute - Seneca Seneca South Carolina United States 29672
    243 Vanderbilt University/Ingram Cancer Center Nashville Tennessee United States 37232
    244 MD Anderson in The Woodlands Conroe Texas United States 77384
    245 Parkland Memorial Hospital Dallas Texas United States 75235
    246 UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas United States 75390
    247 UT Southwestern/Simmons Cancer Center-Fort Worth Fort Worth Texas United States 76104
    248 Lyndon Baines Johnson General Hospital Houston Texas United States 77026-1967
    249 Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas United States 77030
    250 Ben Taub General Hospital Houston Texas United States 77030
    251 Houston Methodist Hospital Houston Texas United States 77030
    252 M D Anderson Cancer Center Houston Texas United States 77030
    253 Michael E DeBakey VA Medical Center Houston Texas United States 77030
    254 MD Anderson West Houston Houston Texas United States 77079
    255 MD Anderson League City League City Texas United States 77573
    256 UT Southwestern Clinical Center at Richardson/Plano Richardson Texas United States 75080
    257 Audie L Murphy VA Hospital San Antonio Texas United States 78229
    258 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229
    259 MD Anderson in Sugar Land Sugar Land Texas United States 77478
    260 Scott and White Memorial Hospital Temple Texas United States 76508
    261 American Fork Hospital / Huntsman Intermountain Cancer Center American Fork Utah United States 84003
    262 Sandra L Maxwell Cancer Center Cedar City Utah United States 84720
    263 Logan Regional Hospital Logan Utah United States 84321
    264 Intermountain Medical Center Murray Utah United States 84107
    265 McKay-Dee Hospital Center Ogden Utah United States 84403
    266 Utah Valley Regional Medical Center Provo Utah United States 84604
    267 Riverton Hospital Riverton Utah United States 84065
    268 Dixie Medical Center Regional Cancer Center Saint George Utah United States 84770
    269 University of Utah Sugarhouse Health Center Salt Lake City Utah United States 84106
    270 Utah Cancer Specialists-Salt Lake City Salt Lake City Utah United States 84106
    271 Huntsman Cancer Institute/University of Utah Salt Lake City Utah United States 84112
    272 LDS Hospital Salt Lake City Utah United States 84143
    273 George E Wahlen Department of Veterans Affairs Medical Center Salt Lake City Utah United States 84148
    274 Central Vermont Medical Center/National Life Cancer Treatment Berlin Vermont United States 05602
    275 University of Vermont Medical Center Burlington Vermont United States 05401
    276 Bon Secours Saint Francis Medical Center Midlothian Virginia United States 23114
    277 Bon Secours Cancer Institute at Reynolds Crossing Richmond Virginia United States 23230
    278 VCU Massey Cancer Center at Stony Point Richmond Virginia United States 23235
    279 Virginia Commonwealth University/Massey Cancer Center Richmond Virginia United States 23298
    280 VCU Community Memorial Health Center South Hill Virginia United States 23970
    281 Seattle Cancer Care Alliance at EvergreenHealth Kirkland Washington United States 98034
    282 Seattle Cancer Care Alliance Seattle Washington United States 98109
    283 University of Washington Medical Center - Montlake Seattle Washington United States 98195
    284 Legacy Salmon Creek Hospital Vancouver Washington United States 98686
    285 West Virginia University Healthcare Morgantown West Virginia United States 26506
    286 Langlade Hospital and Cancer Center Antigo Wisconsin United States 54409
    287 Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin United States 54701
    288 Mayo Clinic Health System-Franciscan Healthcare La Crosse Wisconsin United States 54601
    289 Marshfield Medical Center-Marshfield Marshfield Wisconsin United States 54449
    290 Froedtert Menomonee Falls Hospital Menomonee Falls Wisconsin United States 53051
    291 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    292 Zablocki Veterans Administration Medical Center Milwaukee Wisconsin United States 53295
    293 Marshfield Clinic-Minocqua Center Minocqua Wisconsin United States 54548
    294 Cancer Center of Western Wisconsin New Richmond Wisconsin United States 54017
    295 Marshfield Medical Center-Rice Lake Rice Lake Wisconsin United States 54868
    296 Marshfield Clinic Stevens Point Center Stevens Point Wisconsin United States 54482
    297 Aspirus Regional Cancer Center Wausau Wisconsin United States 54401
    298 Froedtert West Bend Hospital/Kraemer Cancer Center West Bend Wisconsin United States 53095
    299 Diagnostic and Treatment Center Weston Wisconsin United States 54476
    300 Marshfield Medical Center - Weston Weston Wisconsin United States 54476
    301 Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids Wisconsin United States 54494
    302 Instituto Nacional De Cancerologia de Mexico Mexico City Tlalpan Mexico 14080

    Sponsors and Collaborators

    • Southwest Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Brian Chapin, Southwest Oncology Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Southwest Oncology Group
    ClinicalTrials.gov Identifier:
    NCT03678025
    Other Study ID Numbers:
    • S1802
    • NCI-2018-01738
    • S1802
    • S1802
    • U10CA180888
    First Posted:
    Sep 19, 2018
    Last Update Posted:
    Nov 9, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Prednisone
    Cortisone
    Docetaxel
    Leuprolide
    Goserelin
    Bicalutamide
    Triptorelin Pamoate
    Flutamide
    Nilutamide
    Tryptophan

    Study Results

    No Results Posted as of Nov 9, 2021