NCT05806515RecruitingPhase 2
Carboplatin Chemotherapy Before Surgery for People With High-Risk Prostate Cancer and an Inherited BRCA1 or BRCA2 Gene Mutation
S2210 A Phase II Study of Neoadjuvant Carboplatin for Localized, High Risk Prostate Cancer With Germline BRCA1/2 Mutations
Source: ClinicalTrials.gov · Last updated 29 Jan 2026
Brief summary (registry, in English)
This phase II trial tests how well carboplatin before surgery works in treating patients with high-risk prostate cancer and an inherited BRCA1 or BRCA2 gene mutation. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping, or slowing the growth of tumor cells. Giving carboplatin before surgery may shrink tumors in patients with high-risk prostate cancer with BRCA1 and BRCA2 gene mutations.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 44 (estimated)
- First submitted
- 28 Mar 2023
- Start date
- 1 Mar 2024
- Primary completion date
- Jul 2027
- Lead sponsor
- SWOG Cancer Research Network
- Diseases
- Prostate cancer
- NCT number
- NCT05806515
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 44
- From 1 Mar 2024 to the primary completion date, Jul 2027
- 133 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (133)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Providence Regional Cancer System-Aberdeen Coordinator of this site? Confirm its status | Aberdeen | United States | Recruiting |
| Community Hospital of Anaconda Coordinator of this site? Confirm its status | Anaconda | United States | Recruiting |
| Katmai Oncology Group Coordinator of this site? Confirm its status | Anchorage | United States | Recruiting |
| Alaska Breast Care and Surgery LLC Coordinator of this site? Confirm its status | Anchorage | United States | Recruiting |
| Anchorage Oncology Centre Coordinator of this site? Confirm its status | Anchorage | United States | Recruiting |
| Alaska Oncology and Hematology LLC Coordinator of this site? Confirm its status | Anchorage | United States | Recruiting |
| Anchorage Radiation Therapy Center Coordinator of this site? Confirm its status | Anchorage | United States | Recruiting |
| Providence Alaska Medical Center Coordinator of this site? Confirm its status | Anchorage | United States | Recruiting |
| Alaska Women's Cancer Care Coordinator of this site? Confirm its status | Anchorage | United States | Recruiting |
| Anchorage Associates in Radiation Medicine Coordinator of this site? Confirm its status | Anchorage | United States | Recruiting |
| Mission Hope Medical Oncology - Arroyo Grande Coordinator of this site? Confirm its status | Arroyo Grande | United States | Recruiting |
| Saint Alphonsus Medical Center-Baker City Coordinator of this site? Confirm its status | Baker City | United States | Recruiting |
| Flaget Memorial Hospital Coordinator of this site? Confirm its status | Bardstown | United States | Recruiting |
| PeaceHealth Saint Joseph Medical Center Coordinator of this site? Confirm its status | Bellingham | United States | Recruiting |
| Saint Charles Health System Coordinator of this site? Confirm its status | Bend | United States | Recruiting |
| Billings Clinic Cancer Center Coordinator of this site? Confirm its status | Billings | United States | Recruiting |
| Saint Luke's Cancer Institute - Boise Coordinator of this site? Confirm its status | Boise | United States | Recruiting |
| Saint Alphonsus Cancer Care Center-Boise Coordinator of this site? Confirm its status | Boise | United States | Recruiting |
| Bozeman Deaconess Hospital Coordinator of this site? Confirm its status | Bozeman | United States | Recruiting |
| Harrison Medical Center Coordinator of this site? Confirm its status | Bremerton | United States | Recruiting |
| Providence Saint Joseph Medical Center/Disney Family Cancer Center Coordinator of this site? Confirm its status | Burbank | United States | Recruiting |
| Saint Alphonsus Cancer Care Center-Caldwell Coordinator of this site? Confirm its status | Caldwell | United States | Recruiting |
| Mercy San Juan Medical Center Coordinator of this site? Confirm its status | Carmichael | United States | Recruiting |
| Mercy Cancer Center - Carmichael Coordinator of this site? Confirm its status | Carmichael | United States | Recruiting |
| Providence Regional Cancer System-Centralia Coordinator of this site? Confirm its status | Centralia | United States | Recruiting |
| TriHealth Cancer Institute-Anderson Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Bethesda North Hospital Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| TriHealth Cancer Institute-Westside Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Good Samaritan Hospital - Cincinnati Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Clackamas Radiation Oncology Center Coordinator of this site? Confirm its status | Clackamas | United States | Recruiting |
| Providence Cancer Institute Clackamas Clinic Coordinator of this site? Confirm its status | Clackamas | United States | Recruiting |
| Billings Clinic-Cody Coordinator of this site? Confirm its status | Cody | United States | Recruiting |
| Kootenai Health - Coeur d'Alene Coordinator of this site? Confirm its status | Coeur d'Alene | United States | Recruiting |
| Rocky Mountain Cancer Centers-Penrose Coordinator of this site? Confirm its status | Colorado Springs | United States | Recruiting |
| Saint Francis Cancer Center Coordinator of this site? Confirm its status | Colorado Springs | United States | Recruiting |
| Penrose-Saint Francis Healthcare Coordinator of this site? Confirm its status | Colorado Springs | United States | Recruiting |
| Bay Area Hospital Coordinator of this site? Confirm its status | Coos Bay | United States | Recruiting |
| Commonwealth Cancer Center-Corbin Coordinator of this site? Confirm its status | Corbin | United States | Recruiting |
| Alegent Health Mercy Hospital Coordinator of this site? Confirm its status | Council Bluffs | United States | Recruiting |
| Porter Adventist Hospital Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
| Smilow Cancer Hospital-Derby Care Center Coordinator of this site? Confirm its status | Derby | United States | Recruiting |
| City of Hope Comprehensive Cancer Center Coordinator of this site? Confirm its status | Duarte | United States | Recruiting |
| Southwest Oncology PC Coordinator of this site? Confirm its status | Durango | United States | Recruiting |
| Mercy Medical Center Coordinator of this site? Confirm its status | Durango | United States | Recruiting |
| Swedish Cancer Institute-Edmonds Coordinator of this site? Confirm its status | Edmonds | United States | Recruiting |
| Mercy Cancer Center - Elk Grove Coordinator of this site? Confirm its status | Elk Grove | United States | Recruiting |
| Walter Knox Memorial Hospital Coordinator of this site? Confirm its status | Emmett | United States | Recruiting |
| NorthShore University HealthSystem-Evanston Hospital Coordinator of this site? Confirm its status | Evanston | United States | Recruiting |
| Providence Regional Cancer Partnership Coordinator of this site? Confirm its status | Everett | United States | Recruiting |
| Smilow Cancer Hospital Care Center-Fairfield Coordinator of this site? Confirm its status | Fairfield | United States | Recruiting |
| Saint Luke's Cancer Institute - Fruitland Coordinator of this site? Confirm its status | Fruitland | United States | Recruiting |
| Smilow Cancer Hospital Care Center at Glastonbury Coordinator of this site? Confirm its status | Glastonbury | United States | Recruiting |
| NorthShore University HealthSystem-Glenbrook Hospital Coordinator of this site? Confirm its status | Glenview | United States | Recruiting |
| Benefis Healthcare- Sletten Cancer Institute Coordinator of this site? Confirm its status | Great Falls | United States | Recruiting |
| Great Falls Clinic Coordinator of this site? Confirm its status | Great Falls | United States | Recruiting |
| Smilow Cancer Hospital Care Center at Greenwich Coordinator of this site? Confirm its status | Greenwich | United States | Recruiting |
| Smilow Cancer Hospital Care Center - Guilford Coordinator of this site? Confirm its status | Guilford | United States | Recruiting |
| Smilow Cancer Hospital Care Center at Saint Francis Coordinator of this site? Confirm its status | Hartford | United States | Recruiting |
| NorthShore University HealthSystem-Highland Park Hospital Coordinator of this site? Confirm its status | Highland Park | United States | Recruiting |
| City of Hope at Irvine Lennar Coordinator of this site? Confirm its status | Irvine | United States | Recruiting |
| Swedish Cancer Institute-Issaquah Coordinator of this site? Confirm its status | Issaquah | United States | Recruiting |
| Kalispell Regional Medical Center Coordinator of this site? Confirm its status | Kalispell | United States | Recruiting |
| CHI Health Good Samaritan Coordinator of this site? Confirm its status | Kearney | United States | Recruiting |
| Kadlec Clinic Hematology and Oncology Coordinator of this site? Confirm its status | Kennewick | United States | Recruiting |
| Providence Regional Cancer System-Lacey Coordinator of this site? Confirm its status | Lacey | United States | Recruiting |
| Saint Anthony Hospital Coordinator of this site? Confirm its status | Lakewood | United States | Recruiting |
| Saint Joseph Radiation Oncology Resource Center Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
| Saint Joseph Hospital Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
| Saint Joseph Hospital East Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
| Saint Elizabeth Regional Medical Center Coordinator of this site? Confirm its status | Lincoln | United States | Recruiting |
| Littleton Adventist Hospital Coordinator of this site? Confirm its status | Littleton | United States | Recruiting |
| Saint Joseph London Coordinator of this site? Confirm its status | London | United States | Recruiting |
| Longmont United Hospital Coordinator of this site? Confirm its status | Longmont | United States | Recruiting |
| PeaceHealth Saint John Medical Center Coordinator of this site? Confirm its status | Longview | United States | Recruiting |
| Saint Luke's Cancer Institute - Meridian Coordinator of this site? Confirm its status | Meridian | United States | Recruiting |
| Idaho Urologic Institute-Meridian Coordinator of this site? Confirm its status | Meridian | United States | Recruiting |
| LSU Healthcare Network / Metairie Multi-Specialty Clinic Coordinator of this site? Confirm its status | Metairie | United States | Recruiting |
| Garnet Health Medical Center Coordinator of this site? Confirm its status | Middletown | United States | Recruiting |
| Saint Patrick Hospital - Community Hospital Coordinator of this site? Confirm its status | Missoula | United States | Recruiting |
| Community Medical Hospital Coordinator of this site? Confirm its status | Missoula | United States | Suspended |
| Saint Joseph Mount Sterling Coordinator of this site? Confirm its status | Mount Sterling | United States | Recruiting |
| Saint Luke's Cancer Institute - Nampa Coordinator of this site? Confirm its status | Nampa | United States | Recruiting |
| Saint Alphonsus Cancer Care Center-Nampa Coordinator of this site? Confirm its status | Nampa | United States | Recruiting |
| Providence Queen of The Valley Coordinator of this site? Confirm its status | Napa | United States | Recruiting |
| Providence Newberg Medical Center Coordinator of this site? Confirm its status | Newberg | United States | Recruiting |
| Smilow Cancer Center/Yale-New Haven Hospital Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| Louisiana State University Health Science Center Coordinator of this site? Confirm its status | New Orleans | United States | Recruiting |
| Yale-New Haven Hospital North Haven Medical Center Coordinator of this site? Confirm its status | North Haven | United States | Recruiting |
| University of Oklahoma Health Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
| Creighton University Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| Alegent Health Lakeside Hospital Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| Alegent Health Immanuel Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| Alegent Health Bergan Mercy Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| Saint Alphonsus Medical Center-Ontario Coordinator of this site? Confirm its status | Ontario | United States | Recruiting |
| Providence Willamette Falls Medical Center Coordinator of this site? Confirm its status | Oregon City | United States | Recruiting |
| Midlands Community Hospital Coordinator of this site? Confirm its status | Papillion | United States | Recruiting |
| Parker Adventist Hospital Coordinator of this site? Confirm its status | Parker | United States | Recruiting |
| Cancer Center at Saint Joseph's Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
| Providence Portland Medical Center Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Oregon Health and Science University Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Providence Saint Vincent Medical Center Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Kootenai Clinic Cancer Services - Post Falls Coordinator of this site? Confirm its status | Post Falls | United States | Recruiting |
| Saint Mary Corwin Medical Center Coordinator of this site? Confirm its status | Pueblo | United States | Recruiting |
| Saint Charles Health System-Redmond Coordinator of this site? Confirm its status | Redmond | United States | Recruiting |
| Mercy Cancer Center - Rocklin Coordinator of this site? Confirm its status | Rocklin | United States | Recruiting |
| Mercy Cancer Center - Sacramento Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
| Kootenai Cancer Clinic Coordinator of this site? Confirm its status | Sandpoint | United States | Recruiting |
| Pacific Central Coast Health Center-San Luis Obispo Coordinator of this site? Confirm its status | San Luis Obispo | United States | Recruiting |
| Mission Hope Medical Oncology - Santa Maria Coordinator of this site? Confirm its status | Santa Maria | United States | Recruiting |
| Providence Medical Foundation - Santa Rosa Coordinator of this site? Confirm its status | Santa Rosa | United States | Recruiting |
| Providence Santa Rosa Memorial Hospital Coordinator of this site? Confirm its status | Santa Rosa | United States | Recruiting |
| Swedish Medical Center-First Hill Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Swedish Medical Center-Ballard Campus Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Swedish Medical Center-Cherry Hill Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| FHCC South Lake Union Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Fred Hutchinson Cancer Research Center Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| University of Washington Medical Center - Montlake Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| PeaceHealth United General Medical Center Coordinator of this site? Confirm its status | Sedro-Woolley | United States | Recruiting |
| Providence Regional Cancer System-Shelton Coordinator of this site? Confirm its status | Shelton | United States | Recruiting |
| Welch Cancer Center Coordinator of this site? Confirm its status | Sheridan | United States | Recruiting |
| North Shore Medical Center Coordinator of this site? Confirm its status | Skokie | United States | Recruiting |
| Smilow Cancer Hospital Care Center at Long Ridge Coordinator of this site? Confirm its status | Stamford | United States | Recruiting |
| Smilow Cancer Hospital-Torrington Care Center Coordinator of this site? Confirm its status | Torrington | United States | Recruiting |
| Smilow Cancer Hospital Care Center-Trumbull Coordinator of this site? Confirm its status | Trumbull | United States | Recruiting |
| Saint Luke's Cancer Institute - Twin Falls Coordinator of this site? Confirm its status | Twin Falls | United States | Recruiting |
| PeaceHealth Southwest Medical Center Coordinator of this site? Confirm its status | Vancouver | United States | Recruiting |
| Providence Saint Mary Regional Cancer Center Coordinator of this site? Confirm its status | Walla Walla | United States | Recruiting |
| Smilow Cancer Hospital-Waterbury Care Center Coordinator of this site? Confirm its status | Waterbury | United States | Recruiting |
| Smilow Cancer Hospital Care Center - Waterford Coordinator of this site? Confirm its status | Waterford | United States | Recruiting |
| Smilow Cancer Hospital Care Center - Westerly Coordinator of this site? Confirm its status | Westerly | United States | Recruiting |
| Woodland Memorial Hospital Coordinator of this site? Confirm its status | Woodland | United States | Recruiting |
| Providence Regional Cancer System-Yelm Coordinator of this site? Confirm its status | Yelm | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.