Standard Systemic Therapy with or without Definitive Treatment in Treating Participants with Metastatic Prostate Cancer
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.
- STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients must have at least one of the following scans performed, showing evidence of metastatic disease: * Technetium bone scan OR * Computed tomography (CT) of abdomen & pelvis OR * Magnetic resonance imaging (MRI) of pelvis. Scans must be performed between 42 days prior to start of first hormonal therapy and 14 days following start of first hormonal 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), as measured from the date of first hormonal therapy (gonadotrophin releasing hormone [LHRH] agonist or LHRH antagonist) or surgical castration. SST is defined as current National Comprehensive Cancer Network (NCCN) guidelines for metastatic prostate cancer.
- STEP 1 REGISTRATION: PRIOR/CONCURRENT THERAPY CRITERIA: No prior local therapy for prostate adenocarcinoma is allowed (e.g., brachytherapy, high-intensity focused ultrasound ablation [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: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must not have received any prior systemic therapy for prostate cancer, outside of line of SST to be used for duration of study.
- 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 be >= 18 years of age.
- 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 documented PSA: * Prior to initiation of SST * 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 registration. 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 1 REGISTRATION: REGULATORY 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 * Imaging (bone scan and one of the following: CT of abdomen & pelvis, MRI of abdomen & pelvis, CT of abdomen & MRI of pelvis) within 42 days prior to randomization.
- STEP 2 RANDOMIZATION: DISEASE-RELATED CRITERIA: Patients must have no evidence of 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 no more than 28 weeks of SST, as measured from the date of first hormonal therapy (LHRH agonist or LHRH antagonist) 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.
Arizona
Gilbert
Phoenix
Tucson
Arkansas
Little Rock
California
Antioch
Clovis
Duarte
Dublin
Fremont
Fresno
La Jolla
Los Angeles
Marysville
Modesto
Oakland
Palo Alto
Rancho Cordova
Redwood City
Richmond
Rohnert Park
Roseville
Sacramento
San Francisco
San Jose
San Leandro
San Rafael
Santa Clara
Santa Rosa
South San Francisco
Stockton
Truckee
Vacaville
Vallejo
Walnut Creek
Colorado
Aurora
Colorado Springs
Fort Collins
Connecticut
New Haven
Stamford
Delaware
Newark
District of Columbia
Washington
Florida
Coral Gables
Deerfield Beach
Jacksonville
Miami
Orlando
Plantation
Georgia
Atlanta
Augusta
Decatur
Idaho
Caldwell
Nampa
Post Falls
Illinois
Aurora
Bloomington
Canton
Carthage
Chicago
Decatur
Effingham
Eureka
Galesburg
Kewanee
Macomb
Maywood
Ottawa
Pekin
Peoria
Peru
Princeton
Swansea
Urbana
Indiana
Indianapolis
Iowa
Ames
Iowa City
Kansas
Kansas City
Olathe
Overland Park
Westwood
Kentucky
Louisville
Louisiana
Metairie
Maine
Bath
Brewer
Portland
Sanford
Scarborough
Maryland
Baltimore
Massachusetts
Burlington
Michigan
Ann Arbor
Brighton
Brownstown
Canton
Chelsea
Clarkston
Clinton Township
Detroit
Farmington Hills
Grand Rapids
Kalamazoo
Macomb
Madison Heights
Saginaw
Traverse City
Troy
West Bloomfield
Minnesota
Coon Rapids
Fridley
Minneapolis
Robbinsdale
Rochester
Saint Louis Park
Saint Paul
Shakopee
Mississippi
Jackson
Missouri
Cape Girardeau
Columbia
Creve Coeur
Joplin
Kansas City
Saint Louis
Saint Peters
Springfield
Montana
Great Falls
Kalispell
Nebraska
Omaha
Nevada
Henderson
Las Vegas
New Hampshire
Concord
Dover
Manchester
New Jersey
Teaneck
New York
Bronx
Buffalo
Glens Falls
Lake Success
New York
Rochester
Stony Brook
Syracuse
North Carolina
Asheville
Hendersonville
New Bern
Ohio
Canton
Centerville
Cincinnati
Cleveland
Columbus
Dayton
Kettering
West Chester
Oklahoma
Oklahoma City
Oregon
Gresham
Portland
Pennsylvania
Danville
Ephrata
Gettysburg
Lebanon
Lewisburg
Pittsburgh
Wilkes-Barre
York
South Carolina
Boiling Springs
Charleston
Greenville
Greer
Seneca
Tennessee
Nashville
Texas
Conroe
Dallas
Fort Worth
Houston
League City
Richardson
San Antonio
Sugar Land
Temple
Utah
American Fork
Cedar City
Logan
Murray
Ogden
Provo
Riverton
Saint George
Salt Lake City
Vermont
Berlin
Burlington
Virginia
Richmond
South Hill
Washington
Seattle
Vancouver
West Virginia
Morgantown
Wisconsin
Antigo
Eau Claire
La Crosse
Marshfield
Menomonee Falls
Milwaukee
Minocqua
New Richmond
Rice Lake
Stevens Point
Wausau
West Bend
Weston
PRIMARY OBJECTIVE:
I. To compare overall survival in metastatic prostate cancer patients who are randomized to standard systemic therapy (SST) plus definitive treatment of the primary tumor versus standard systemic therapy alone.
SECONDARY OBJECTIVES:
I. To compare overall survival in metastatic prostate cancer patients who received SST plus surgical excision of the primary tumor versus SST alone in the subset who specify the surgical intent stratification factor.
II. To compare the rate of symptomatic local progression between the treatment arms.
III. To compare progression-free survival (PFS) between the two treatment arms.
IV. To compare rates of progression-free survival between arms for the subsets of patients with and without metastasis directed therapy (MDT) to oligometastatic sites.
QUALITY OF LIFE OBJECTIVE:
I. To compare between arms patient-reported urinary function and urinary bother over time (after initiation of SST at 6 months, 1, 2, and 3 years) using the Expanded Prostate Cancer Index Composite (EPIC) and patient-reported pain and physical functioning using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) between patients receiving standard systemic therapy and those receiving systemic therapy and definitive management of the primary prostate cancer.
OTHER OBJECTIVE:
I. To bank tissue and whole blood specimens for future use.
OUTLINE:
INDUCTION: Participants receive 1 of 6 acceptable forms of SST for 22-28 weeks.
I. Participants undergo a bilateral orchiectomy.
II. Participants receive goserelin acetate subcutaneously (SC) every 28 days or 12 weeks, histrelin acetate SC every 12 months, leuprolide acetate SC or intramuscularly (IM) every 1, 3, 4, or 6 months, and triptorelin every 1, 3, or 6 months.
III. Participants receive goserelin acetate SC every 28 days or 12 weeks, histrelin acetate SC every 12 months, leuprolide acetate SC or IM every 1, 3, 4, or 6 months, and triptorelin every 1, 3, or 6 months. Participants also receive nilutamide orally (PO) daily, flutamide PO every 8 hours, and bicalutamide PO daily.
IV. Participants receive degarelix via injection for 2 doses and then every 28 days.
V. Participants receive nilutamide PO daily, flutamide PO every 8 hours, and bicalutamide PO daily. Participants also receive docetaxel over 1 hour every 3 weeks with or without prednisone PO every 12 hours.
VI. Participants receive nilutamide PO daily, flutamide PO every 8 hours, and bicalutamide PO daily. Participants also receive abiraterone PO daily or prednisone PO every 12 hours.
After completion of 22-28 weeks of SST, participants are then randomized to 1 of 2 arms.
ARM I: Participants receive 1 acceptable form of SST as in Induction except for treatment with docetaxel and prednisone.
ARM II: Participants receive 1 acceptable form of SST as in Induction except for treatment with docetaxel and prednisone. Participants undergo prostatectomy within 8 weeks after randomization or radiation therapy within 4 weeks of randomization.
After completion of study treatment, participants are followed up for 8 years.
Trial Phase Phase III
Trial Type Treatment
Lead Organization
SWOG
Principal Investigator
Brian Francis Chapin
- Primary ID S1802
- Secondary IDs NCI-2018-01738
- Clinicaltrials.gov ID NCT03678025