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Search / Trial NCT03678025

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 01, 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.

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

0 patients applied

Trial Officials

Brian Chapin

Principal Investigator

SWOG Cancer Research Network

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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