Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer
Launched by SWOG CANCER RESEARCH NETWORK · Sep 18, 2018
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring how effective standard systemic therapy is when combined with additional treatments, like prostate removal surgery or radiation therapy, for men with metastatic prostate cancer. Metastatic prostate cancer means the cancer has spread to other parts of the body. The goal is to see if adding these treatments can help slow down or stop the cancer from growing or spreading further.
To participate in this trial, men need to be between the ages of 65 and 74 and must have a confirmed diagnosis of prostate adenocarcinoma, which is a specific type of prostate cancer. They should also have evidence that the cancer has spread, as shown through certain imaging tests. Participants should not have had surgery or radiation for prostate cancer before and should not have brain metastases. Throughout the trial, participants will receive regular check-ups and tests to monitor their health and the cancer's progress. This study is currently recruiting participants, and anyone considering joining will need to give their informed consent after learning about the trial.
Gender
MALE
Eligibility criteria
- Inclusion Criteria:
- • STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: All patients must have a histologically or cytologically proven diagnosis of adenocarcinoma of the prostate. Patients with pure small cell carcinoma\* (SCC), sarcomatoid, or squamous cell carcinoma are not eligible. (\*morphology must be consistent with SCC; synaptophysin or chromogranin positive by immunohistochemical staining is insufficient to diagnose SCC).
- • STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients must have an intact prostate. No prior local therapy for prostate adenocarcinoma is allowed (e.g., brachytherapy, high-intensity focused ultrasound \[HIFU\], cryotherapy, laser ablative therapies). Any prior therapy for benign conditions, such as obstruction, are acceptable (e.g., transurethral resection of the prostate, greenlight laser ablation, microwave ablation).
- • STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients must have evidence of metastatic disease on technetium bone scan and computed tomography (CT) or magnetic resonance imaging (MRI) within 42 days prior to starting standard systemic therapy. Metastatic disease that is detected by positron emission tomography (PET) scan only (sodium fluoride \[NaF\], prostate-specific membrane antigen \[PSMA\], anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic acid \[FACBC\], carbon \[C\]11) but not conventional imaging (technetium \[Tc\]99 bone scan, CT or MRI) or solitary metastases by conventional imaging, must be confirmed histologically or cytologically.
- • STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients with known brain metastases are not eligible. Brain imaging studies are not required for eligibility if the patient has no neurologic signs or symptoms suggestive of brain metastasis. If brain imaging studies are performed, they must be negative for disease.
- • STEP 1 REGISTRATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must have received no more than 28 weeks of standard systemic therapy (SST). SST is defined as current National Comprehensive Cancer Network (NCCN) guidelines for metastatic prostate cancer.
- • STEP 1 REGISTRATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must not have progressed while on SST.
- • STEP 1 REGISTRATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients with oligometastatic prostate cancer may receive metastasis directed therapy to up to four sites of disease prior to randomization.
- • STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: Patients must have a complete physical examination and medical history within 28 days prior to registration.
- • STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: Patients must have a PSA documented prior to initiation of SST and within 28 days prior to registration. Any additional PSAs measured while receiving SST should be recorded.
- • STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: Patients must have a testosterone lab documented within 28 days prior to randomization. Any additional testosterone labs measured while receiving SST should be recorded as well as pretreatment initiation if available.
- • STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated stage 0, I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years.
- • STEP 1 REGISTRATION: SPECIMEN SUBMISSION CRITERIA: Patients must be offered the opportunity to participate in translational medicine studies and specimen banking for future studies.
- • STEP 1 REGISTRATION: QUALITY OF LIFE CRITERIA: Patients who can complete Patient-Reported Outcome instruments in English, Spanish or French, must participate in the quality of life studies.
- • STEP 1 REGISTRATION: REGULATORY CRITERIA: Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
- • STEP 2 RANDOMIZATION: DISEASE-RELATED CRITERIA: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.
- • STEP 2 RANDOMIZATION: DISEASE-RELATED CRITERIA: Patients must have no evidence of disease progression during the 28 weeks of SST by PSA measure, bone scan and CT or MRI or symptomatic deterioration (as defined by physician discretion) within 28 days prior to randomization.
- • STEP 2 RANDOMIZATION: DISEASE-RELATED CRITERIA: Patients must have consultation with a urologist and have surgically resectable disease regardless of definitive treatment intent or randomization.
- • STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must have received between 22 and 28 weeks of SST as measured from the date of first hormonal therapy or surgical castration. SST is defined by current NCCN guidelines for metastatic prostate cancer.
- • STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must not be planning to receive docetaxel after randomization.
- • STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Any toxicities from SST must have resolved to =\< grade 1 (Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0) prior to randomization.
- • STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients may have received elective metastasis directed therapy to oligometastatic sites (=\< 4 sites). All treatment must be completed prior to randomization.
- • STEP 2 RANDOMIZATION: CLINICAL/LABORATORY CRITERIA: Patients must have a PSA performed within 28 days prior to randomization.
- • STEP 2 RANDOMIZATION: CLINICAL/LABORATORY CRITERIA: Patients must have a testosterone \< 50 ng/dL within 28 days prior to randomization.
- • STEP 2 RANDOMIZATION: CLINICAL/LABORATORY CRITERIA: Patients must have a Zubrod performance status of 0 ? 1 within 28 days prior to randomization.
About Swog Cancer Research Network
The SWOG Cancer Research Network is a leading cancer clinical trial organization dedicated to improving cancer treatment and outcomes through innovative research. Comprising a collaborative network of academic institutions, community hospitals, and cancer centers, SWOG conducts rigorous clinical trials that advance the understanding of cancer biology, prevention, and therapy. With a strong emphasis on inclusivity and diversity, SWOG aims to ensure that clinical research reflects the populations affected by cancer, ultimately striving to enhance patient care and quality of life. Through its commitment to scientific excellence and collaboration, SWOG plays a pivotal role in shaping the future of oncology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
New Haven, Connecticut, United States
Lebanon, New Hampshire, United States
Milwaukee, Wisconsin, United States
Charleston, South Carolina, United States
Buffalo, New York, United States
Washington, District Of Columbia, United States
Saint Louis, Missouri, United States
Denver, Colorado, United States
Edina, Minnesota, United States
Maywood, Illinois, United States
Peoria, Illinois, United States
Detroit, Michigan, United States
Salt Lake City, Utah, United States
Little Rock, Arkansas, United States
Hackensack, New Jersey, United States
Oklahoma City, Oklahoma, United States
Temple, Texas, United States
Duarte, California, United States
Des Moines, Iowa, United States
Cleveland, Ohio, United States
Greeley, Colorado, United States
Loveland, Colorado, United States
Ann Arbor, Michigan, United States
Kalamazoo, Michigan, United States
Traverse City, Michigan, United States
Jackson, Mississippi, United States
Bozeman, Montana, United States
Kalispell, Montana, United States
Logan, Utah, United States
Ogden, Utah, United States
Chicago, Illinois, United States
Houston, Texas, United States
Dallas, Texas, United States
Fort Collins, Colorado, United States
Gresham, Oregon, United States
Coon Rapids, Minnesota, United States
Urbana, Illinois, United States
Ann Arbor, Michigan, United States
Saint Paul, Minnesota, United States
Shakopee, Minnesota, United States
Effingham, Illinois, United States
Weston, Wisconsin, United States
Philadelphia, Pennsylvania, United States
Houston, Texas, United States
San Antonio, Texas, United States
Minneapolis, Minnesota, United States
Rochester, New York, United States
Toledo, Ohio, United States
Danville, Pennsylvania, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Scottsdale, Arizona, United States
Clovis, California, United States
Los Angeles, California, United States
Palo Alto, California, United States
Sacramento, California, United States
Aurora, Colorado, United States
Washington, District Of Columbia, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Iowa City, Iowa, United States
Baltimore, Maryland, United States
Detroit, Michigan, United States
Columbia, Missouri, United States
Saint Louis, Missouri, United States
Omaha, Nebraska, United States
New York, New York, United States
Syracuse, New York, United States
Columbus, Ohio, United States
Pittsburgh, Pennsylvania, United States
Nashville, Tennessee, United States
Newark, Delaware, United States
Aurora, Illinois, United States
Lexington, Kentucky, United States
Bronx, New York, United States
Charlotte, North Carolina, United States
Kettering, Ohio, United States
Morgantown, West Virginia, United States
Provo, Utah, United States
Cape Girardeau, Missouri, United States
Aventura, Florida, United States
Washington, District Of Columbia, United States
Fridley, Minnesota, United States
Robbinsdale, Minnesota, United States
Saint Louis Park, Minnesota, United States
Portland, Oregon, United States
Berlin, Vermont, United States
Omaha, Nebraska, United States
Glens Falls, New York, United States
Louisville, Kentucky, United States
Oakland, California, United States
Miami, Florida, United States
Albany, New York, United States
Stony Brook, New York, United States
Dallas, Texas, United States
Houston, Texas, United States
Richmond, Virginia, United States
Orlando, Florida, United States
Augusta, Georgia, United States
Rochester, Minnesota, United States
Saint Louis, Missouri, United States
Bronx, New York, United States
Asheville, North Carolina, United States
Toledo, Ohio, United States
Marshfield, Wisconsin, United States
Miami Beach, Florida, United States
Decatur, Illinois, United States
Decatur, Georgia, United States
Ottawa, Illinois, United States
Peoria, Illinois, United States
Peoria, Illinois, United States
Butte, Montana, United States
Lansing, Michigan, United States
Palm Springs, California, United States
Rochester, New York, United States
Cape Girardeau, Missouri, United States
Great Falls, Montana, United States
Wilkes Barre, Pennsylvania, United States
Rohnert Park, California, United States
Sacramento, California, United States
Fremont, California, United States
Redwood City, California, United States
Richmond, California, United States
Roseville, California, United States
Sacramento, California, United States
San Francisco, California, United States
San Jose, California, United States
San Leandro, California, United States
Santa Clara, California, United States
Santa Rosa, California, United States
South San Francisco, California, United States
Stockton, California, United States
Vallejo, California, United States
Walnut Creek, California, United States
Atlanta, Georgia, United States
Galesburg, Illinois, United States
Richmond, Indiana, United States
Ames, Iowa, United States
Kansas City, Kansas, United States
Portland, Maine, United States
Grand Rapids, Michigan, United States
Saginaw, Michigan, United States
Joplin, Missouri, United States
Springfield, Missouri, United States
Springfield, Missouri, United States
Billings, Montana, United States
Canton, Ohio, United States
Cincinnati, Ohio, United States
Dayton, Ohio, United States
Sylvania, Ohio, United States
Portland, Oregon, United States
Ephrata, Pennsylvania, United States
American Fork, Utah, United States
Cedar City, Utah, United States
Murray, Utah, United States
Saint George, Utah, United States
Salt Lake City, Utah, United States
Burlington, Vermont, United States
South Hill, Virginia, United States
Seattle, Washington, United States
Minocqua, Wisconsin, United States
Rice Lake, Wisconsin, United States
Stevens Point, Wisconsin, United States
Weston, Wisconsin, United States
Kettering, Ohio, United States
Stamford, Connecticut, United States
Jacksonville, Florida, United States
Burlington, Massachusetts, United States
Concord, New Hampshire, United States
Manchester, New Hampshire, United States
Antigo, Wisconsin, United States
Wausau, Wisconsin, United States
San Antonio, Texas, United States
Littleton, Colorado, United States
Marysville, California, United States
Hendersonville, North Carolina, United States
Tucson, Arizona, United States
Houston, Texas, United States
Canton, Illinois, United States
Carthage, Illinois, United States
Eureka, Illinois, United States
Kewanee, Illinois, United States
Macomb, Illinois, United States
Peru, Illinois, United States
Princeton, Illinois, United States
Parker, Colorado, United States
La Jolla, California, United States
Lake Success, New York, United States
Houston, Texas, United States
Greenville, South Carolina, United States
Atlanta, Georgia, United States
Truckee, California, United States
Colorado Springs, Colorado, United States
Edwards, Colorado, United States
Post Falls, Idaho, United States
Bloomington, Illinois, United States
Pekin, Illinois, United States
Scarborough, Maine, United States
Manchester, New Hampshire, United States
Concord, North Carolina, United States
Boiling Springs, South Carolina, United States
Greenville, South Carolina, United States
Greer, South Carolina, United States
Seneca, South Carolina, United States
Saint George, Utah, United States
La Crosse, Wisconsin, United States
Wisconsin Rapids, Wisconsin, United States
Teaneck, New Jersey, United States
York, Pennsylvania, United States
Los Angeles, California, United States
Gettysburg, Pennsylvania, United States
Vacaville, California, United States
Olathe, Kansas, United States
Saint Louis, Missouri, United States
Tucson, Arizona, United States
Antioch, California, United States
Fresno, California, United States
Modesto, California, United States
Oakland, California, United States
Rancho Cordova, California, United States
Roseville, California, United States
South San Francisco, California, United States
Atlanta, Georgia, United States
Overland Park, Kansas, United States
Kansas City, Missouri, United States
Rolla, Missouri, United States
Dover, New Hampshire, United States
Monroe, North Carolina, United States
Rock Hill, South Carolina, United States
Kirkland, Washington, United States
Vancouver, Washington, United States
New Richmond, Wisconsin, United States
Myrtle Beach, South Carolina, United States
Las Vegas, Nevada, United States
Aarau, , Switzerland
Saint Peters, Missouri, United States
Pittsburgh, Pennsylvania, United States
Sugar Land, Texas, United States
Newark, Delaware, United States
Caldwell, Idaho, United States
Nampa, Idaho, United States
Brighton, Michigan, United States
Canton, Michigan, United States
Chelsea, Michigan, United States
Pontiac, Michigan, United States
Minneapolis, Minnesota, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Centerville, Ohio, United States
West Chester, Ohio, United States
Lewisburg, Pennsylvania, United States
Lexington, Kentucky, United States
Lexington, Kentucky, United States
Boulder, Colorado, United States
Swansea, Illinois, United States
Brownstown, Michigan, United States
Clinton Township, Michigan, United States
West Bloomfield, Michigan, United States
Sainte Genevieve, Missouri, United States
Conroe, Texas, United States
Houston, Texas, United States
League City, Texas, United States
Richmond, Virginia, United States
Clovis, California, United States
Dublin, California, United States
Fresno, California, United States
Sacramento, California, United States
San Rafael, California, United States
Creve Coeur, Missouri, United States
Saint Louis, Missouri, United States
Lebanon, Pennsylvania, United States
Greenville, South Carolina, United States
Riverton, Utah, United States
Eau Claire, Wisconsin, United States
Milwaukee, Wisconsin, United States
Stevens Point, Wisconsin, United States
Bronx, New York, United States
Menomonee Falls, Wisconsin, United States
West Bend, Wisconsin, United States
Trumbull, Connecticut, United States
Westwood, Kansas, United States
Phoenix, Arizona, United States
Chambersburg, Pennsylvania, United States
Midlothian, Virginia, United States
Coral Gables, Florida, United States
Deerfield Beach, Florida, United States
Charlotte, North Carolina, United States
Bogota, , Colombia
Mexico City, Tlalpan, Mexico
Phoenix, Arizona, United States
Sacramento, California, United States
San Luis Obispo, California, United States
Bath, Maine, United States
Sanford, Maine, United States
Metairie, Louisiana, United States
Brewer, Maine, United States
Fort Worth, Texas, United States
Miami, Florida, United States
Rock Hill, South Carolina, United States
Gilbert, Arizona, United States
Guilford, Connecticut, United States
Waterford, Connecticut, United States
Albemarle, North Carolina, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Stevens Point, Wisconsin, United States
Clarkston, Michigan, United States
Farmington Hills, Michigan, United States
Troy, Michigan, United States
New Bern, North Carolina, United States
West Haven, Connecticut, United States
Colorado Springs, Colorado, United States
Long Beach, California, United States
Metairie, Louisiana, United States
Plantation, Florida, United States
Bellevue, Nebraska, United States
Omaha, Nebraska, United States
Sanford, Maine, United States
Oak Creek, Wisconsin, United States
Salt Lake City, Utah, United States
Richmond, Virginia, United States
Richardson, Texas, United States
Macomb, Michigan, United States
Gastonia, North Carolina, United States
Madison Heights, Michigan, United States
Salt Lake City, Utah, United States
Oneida, New York, United States
Oswego, New York, United States
Dansville, New York, United States
Seattle, Washington, United States
Independence, , Chile
Seattle, Washington, United States
Seattle, Washington, United States
Bellevue, Washington, United States
Dallas, Texas, United States
Lebanon, New Hampshire, United States
Nampa, Idaho, United States
Guilford, Connecticut, United States
Ames, Iowa, United States
Patients applied
Trial Officials
Brian Chapin
Principal Investigator
SWOG Cancer Research Network
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials