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.
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
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Loveland, Colorado, United States
Ann Arbor, Michigan, United States
Kalamazoo, Michigan, United States
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Jackson, Mississippi, United States
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Kalispell, Montana, United States
Logan, Utah, United States
Ogden, Utah, United States
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Gresham, Oregon, United States
Coon Rapids, Minnesota, United States
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Effingham, Illinois, United States
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Philadelphia, Pennsylvania, United States
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Midlothian, Virginia, United States
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Deerfield Beach, Florida, United States
Charlotte, North Carolina, United States
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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
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Clarkston, Michigan, United States
Farmington Hills, Michigan, United States
Troy, Michigan, United States
New Bern, North Carolina, United States
West Haven, Connecticut, United States
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Long Beach, California, United States
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Bellevue, Nebraska, United States
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Richmond, Virginia, United States
Richardson, Texas, United States
Macomb, Michigan, United States
Gastonia, North Carolina, United States
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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
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