Carboplatin treatment before surgery for high-risk prostate cancer with BRCA mutations
Official title: S2210 A Phase II Study of Neoadjuvant Carboplatin for Localized, High Risk Prostate Cancer With Germline BRCA1/2 Mutations
Run by SWOG Cancer Research Network · NCT05806515 · Data updated 2026-11-12
This study is testing if giving carboplatin chemotherapy before surgery can help men with high-risk prostate cancer and BRCA mutations have better outcomes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 44 (estimated) |
| Sponsor | SWOG Cancer Research Network Research network |
| Drugs / interventions | radiation |
| Locations | 133 sites (Anchorage, Alaska and 132 other locations) |
| Status | Recruiting |
| Started | March 1, 2024 |
| Main results expected | July 2027 |
| Study ends | June 2031 |
| Registry record updated | January 29, 2026 |
| Trial ID | NCT05806515 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with a histologic diagnosis of high-risk prostate adenocarcinoma and documented BRCA1 or BRCA2 mutations.
✕Probably not a fit
Patients without BRCA1 or BRCA2 mutations or those with low-risk prostate cancer may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase II trial evaluates the effectiveness of carboplatin chemotherapy administered before surgery in patients with high-risk prostate cancer who have inherited BRCA1 or BRCA2 gene mutations. The primary goal is to assess the rate of complete pathological response at the time of prostatectomy. Secondary objectives include monitoring prostate-specific antigen (PSA) progression-free survival, metastasis-free survival, overall survival, and the safety profile of the treatment. Patients will receive carboplatin intravenously and undergo surgery, with follow-up imaging and blood sample collection throughout the trial.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and survival rates for patients with high-risk prostate cancer and BRCA mutations.
How similar studies have gone: Other studies have shown promising results with neoadjuvant chemotherapy in similar contexts, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant must have histologic diagnosis of prostate adenocarcinoma * Participant must have high or very high-risk disease defined by at least one of the following: * cT3a - cT4x * Grade group 4 or 5 (Gleason sum 8-10) * PSA \> 20 ng/mL prior to registration * Participant must have documented evidence of germline mutation (pathogenic/likely pathogenic variant) in BRCA2 or BRCA1 through testing in a Clinical Laboratory Improvement Act (CLIA)-certified lab * NOTE: Local lab report is sufficient for eligibility * Participant may have initiated gonadotrophin releasing hormone (gnRH) agonist, gnRH antagonist, oral anti-androgen (e.g. bicalutamide, nilutamide, flutamide), or other agent intended to treat prostate cancer prior to registration. The effectiveness of the current depot of such treatment must not extend beyond 1 month after study registration. Agents listed above cannot be started after participant registration * Participant must be \>= 18 years old * Participant must have Zubrod performance status of 0-2 * Participant must have a complete medical history and physical exam within 28 days prior to registration * Absolute neutrophil count \>= 1.5 x 10\^3/uL (within 28 days prior to registration) * Platelets \>= 100 x 10\^3/uL (within 28 days prior to registration) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 x institutional upper limit of normal (ULN) (within 28 days prior to registration) * Participant must have a serum creatinine =\< the institutional upper limit of normal (IULN) OR measured OR calculated creatinine clearance \>= 50 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration * Participant must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification within 28 days prior to registration. To be eligible for this trial, participants must be class 2B or better * Participant with known human immunodeficiency virus (HIV)-infection must be receiving anti-retroviral therapy and have an undetectable viral load test within 6 months prior to registration * Participant with history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within in 28 days prior to registration * Participant with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment must have an undetectable HCV viral load within in 28 days prior to registration * Participants who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including vasectomy with testing showing no sperm in the semen * Prior to registration, participant must have had a urologic consult and be deemed a surgical candidate with known sites of disease deemed by the urologist to be potentially resectable * Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System * NOTE: 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 * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations * As part of the 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 Exclusion Criteria: * Participant must not have evidence of distant metastatic disease by conventional imaging within 90 days prior to registration * NOTE: cN1 detected only by PSMA-PET is permitted if urologist deems sites of disease to be potentially completely resectable * Participant must not have received prior radiation therapy (RT) to the pelvic region * Participant must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of protocol treatment
Where it's running
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Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States Recruiting -
Anchorage Radiation Therapy Center
Anchorage, Alaska, United States Recruiting -
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States Recruiting -
Alaska Oncology and Hematology LLC
Anchorage, Alaska, United States Recruiting -
Alaska Women's Cancer Care
Anchorage, Alaska, United States Recruiting -
Anchorage Oncology Centre
Anchorage, Alaska, United States Recruiting
Show 44 more locations
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Katmai Oncology Group
Anchorage, Alaska, United States Recruiting -
Providence Alaska Medical Center
Anchorage, Alaska, United States Recruiting -
Cancer Center at Saint Joseph's
Phoenix, Arizona, United States Recruiting -
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, United States Recruiting -
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States Recruiting -
Mercy Cancer Center �� Carmichael
Carmichael, California, United States Recruiting -
Mercy San Juan Medical Center
Carmichael, California, United States Recruiting -
City of Hope Comprehensive Cancer Center
Duarte, California, United States Recruiting -
Mercy Cancer Center - Elk Grove
Elk Grove, California, United States Recruiting -
City of Hope at Irvine Lennar
Irvine, California, United States Recruiting -
Providence Queen of The Valley
Napa, California, United States Recruiting -
Mercy Cancer Center - Rocklin
Rocklin, California, United States Recruiting -
Mercy Cancer Center - Sacramento
Sacramento, California, United States Recruiting -
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California, United States Recruiting -
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California, United States Recruiting -
Providence Medical Foundation - Santa Rosa
Santa Rosa, California, United States Recruiting -
Providence Santa Rosa Memorial Hospital
Santa Rosa, California, United States Recruiting -
Woodland Memorial Hospital
Woodland, California, United States Recruiting -
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States Recruiting -
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, United States Recruiting -
Saint Francis Cancer Center
Colorado Springs, Colorado, United States Recruiting -
Porter Adventist Hospital
Denver, Colorado, United States Recruiting -
Mercy Medical Center
Durango, Colorado, United States Recruiting -
Southwest Oncology PC
Durango, Colorado, United States Recruiting -
Saint Anthony Hospital
Lakewood, Colorado, United States Recruiting -
Littleton Adventist Hospital
Littleton, Colorado, United States Recruiting -
Longmont United Hospital
Longmont, Colorado, United States Recruiting -
Parker Adventist Hospital
Parker, Colorado, United States Recruiting -
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States Recruiting -
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, United States Recruiting -
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, United States Recruiting -
Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut, United States Recruiting -
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, United States Recruiting -
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, United States Recruiting -
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States Recruiting -
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut, United States Recruiting -
Yale University
New Haven, Connecticut, United States Recruiting -
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, United States Recruiting -
Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut, United States Recruiting -
Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut, United States Recruiting -
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, United States Recruiting -
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut, United States Recruiting -
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, United States Recruiting -
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States Recruiting
+83 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Heather H Cheng — SWOG Cancer Research Network
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Combining high dose-rate brachytherapy and stereotactic body radiotherapy for prostate cancer treatment
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Hormone therapy and targeted radiation for prostate cancer treatment
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Androgen therapy with or without niraparib for high-risk prostate cancer after radiation
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Proton radiation therapy for high-risk prostate cancer
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PSMA-targeted therapy with hormone suppression for low-volume metastatic prostate cancer
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.