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Carboplatin Chemotherapy Before Surgery for People With High-Risk Prostate Cancer and an Inherited BRCA1 or BRCA2 Gene Mutation

NCT05806515 · SWOG Cancer Research Network
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Official title
S2210 A Phase II Study of Neoadjuvant Carboplatin for Localized, High Risk Prostate Cancer With Germline BRCA1/2 Mutations
About this study
PRIMARY OBJECTIVE: I. To evaluate the pathologic complete response rate at prostatectomy in patients with localized high-risk prostate cancer with germline BRCA2 or BRCA1 mutations who are treated with neoadjuvant carboplatin by central review of source documents. SECONDARY OBJECTIVES: I. To evaluate prostate specific antigen (PSA) progression-free survival post-prostatectomy over the duration of follow-up and specifically, at the 3-year landmark. II. To evaluate metastases free survival and overall survival. III. To evaluate the frequency and severity of toxicities of neoadjuvant carboplatin followed by radical prostatectomy. BANKING OBJECTIVE: I. To bank specimens for future correlative studies. OUTLINE: Patients receive carboplatin intravenously (IV) on study. Patients then undergo surgery on study. Patients who experience PSA progression after surgery undergo computed tomography (CT) or magnetic resonance imaging (MRI) of the abdomen and pelvis, CT of the chest or chest X-ray, or prostate-specific membrane antigen (PSMA)-positron emission tomography (PET) throughout the trial. Patients also undergo collection of blood samples throughout the trial.
Eligibility 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
Study design
Enrollment target: 44 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-03-01
Estimated completion: 2031-06
Last updated: 2026-01-29
Interventions
Procedure: Biospecimen CollectionDrug: CarboplatinProcedure: Chest RadiographyProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingProcedure: PSMA PET ScanProcedure: Surgical Procedure
Primary outcomes
  • Pathologic complete response after neoadjuvant carboplatin (Up to 5 years)
Sponsor
SWOG Cancer Research Network · network
With: National Cancer Institute (NCI)
Contacts & investigators
InvestigatorHeather H Cheng · principal_investigator, SWOG Cancer Research Network
All locations (133)
Anchorage Associates in Radiation MedicineRecruiting
Anchorage, Alaska, United States
Anchorage Radiation Therapy CenterRecruiting
Anchorage, Alaska, United States
Alaska Breast Care and Surgery LLCRecruiting
Anchorage, Alaska, United States
Alaska Oncology and Hematology LLCRecruiting
Anchorage, Alaska, United States
Alaska Women's Cancer CareRecruiting
Anchorage, Alaska, United States
Anchorage Oncology CentreRecruiting
Anchorage, Alaska, United States
Katmai Oncology GroupRecruiting
Anchorage, Alaska, United States
Providence Alaska Medical CenterRecruiting
Anchorage, Alaska, United States
Cancer Center at Saint Joseph'sRecruiting
Phoenix, Arizona, United States
Mission Hope Medical Oncology - Arroyo GrandeRecruiting
Arroyo Grande, California, United States
Providence Saint Joseph Medical Center/Disney Family Cancer CenterRecruiting
Burbank, California, United States
Mercy Cancer Center �� CarmichaelRecruiting
Carmichael, California, United States
Mercy San Juan Medical CenterRecruiting
Carmichael, California, United States
City of Hope Comprehensive Cancer CenterRecruiting
Duarte, California, United States
Mercy Cancer Center - Elk GroveRecruiting
Elk Grove, California, United States
City of Hope at Irvine LennarRecruiting
Irvine, California, United States
Providence Queen of The ValleyRecruiting
Napa, California, United States
Mercy Cancer Center - RocklinRecruiting
Rocklin, California, United States
Mercy Cancer Center - SacramentoRecruiting
Sacramento, California, United States
Pacific Central Coast Health Center-San Luis ObispoRecruiting
San Luis Obispo, California, United States
Mission Hope Medical Oncology - Santa MariaRecruiting
Santa Maria, California, United States
Providence Medical Foundation - Santa RosaRecruiting
Santa Rosa, California, United States
Providence Santa Rosa Memorial HospitalRecruiting
Santa Rosa, California, United States
Woodland Memorial HospitalRecruiting
Woodland, California, United States
Penrose-Saint Francis HealthcareRecruiting
Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers-PenroseRecruiting
Colorado Springs, Colorado, United States
Saint Francis Cancer CenterRecruiting
Colorado Springs, Colorado, United States
Porter Adventist HospitalRecruiting
Denver, Colorado, United States
Mercy Medical CenterRecruiting
Durango, Colorado, United States
Southwest Oncology PCRecruiting
Durango, Colorado, United States
Saint Anthony HospitalRecruiting
Lakewood, Colorado, United States
Littleton Adventist HospitalRecruiting
Littleton, Colorado, United States
Longmont United HospitalRecruiting
Longmont, Colorado, United States
Parker Adventist HospitalRecruiting
Parker, Colorado, United States
Saint Mary Corwin Medical CenterRecruiting
Pueblo, Colorado, United States
Smilow Cancer Hospital-Derby Care CenterRecruiting
Derby, Connecticut, United States
Smilow Cancer Hospital Care Center-FairfieldRecruiting
Fairfield, Connecticut, United States
Smilow Cancer Hospital Care Center at GlastonburyRecruiting
Glastonbury, Connecticut, United States
Smilow Cancer Hospital Care Center at GreenwichRecruiting
Greenwich, Connecticut, United States
Smilow Cancer Hospital Care Center - GuilfordRecruiting
Guilford, Connecticut, United States
Smilow Cancer Hospital Care Center at Saint FrancisRecruiting
Hartford, Connecticut, United States
Smilow Cancer Center/Yale-New Haven HospitalRecruiting
New Haven, Connecticut, United States
Yale UniversityRecruiting
New Haven, Connecticut, United States
Yale-New Haven Hospital North Haven Medical CenterRecruiting
North Haven, Connecticut, United States
Smilow Cancer Hospital Care Center at Long RidgeRecruiting
Stamford, Connecticut, United States
Smilow Cancer Hospital-Torrington Care CenterRecruiting
Torrington, Connecticut, United States
Smilow Cancer Hospital Care Center-TrumbullRecruiting
Trumbull, Connecticut, United States
Smilow Cancer Hospital-Waterbury Care CenterRecruiting
Waterbury, Connecticut, United States
Smilow Cancer Hospital Care Center - WaterfordRecruiting
Waterford, Connecticut, United States
Saint Alphonsus Cancer Care Center-BoiseRecruiting
Boise, Idaho, United States
Saint Luke's Cancer Institute - BoiseRecruiting
Boise, Idaho, United States
Saint Alphonsus Cancer Care Center-CaldwellRecruiting
Caldwell, Idaho, United States
Kootenai Health - Coeur d'AleneRecruiting
Coeur d'Alene, Idaho, United States
Walter Knox Memorial HospitalRecruiting
Emmett, Idaho, United States
Saint Luke's Cancer Institute - FruitlandRecruiting
Fruitland, Idaho, United States
Idaho Urologic Institute-MeridianRecruiting
Meridian, Idaho, United States
Saint Luke's Cancer Institute - MeridianRecruiting
Meridian, Idaho, United States
Saint Luke's Cancer Institute - NampaRecruiting
Nampa, Idaho, United States
Saint Alphonsus Cancer Care Center-NampaRecruiting
Nampa, Idaho, United States
Kootenai Clinic Cancer Services - Post FallsRecruiting
Post Falls, Idaho, United States
Kootenai Cancer ClinicRecruiting
Sandpoint, Idaho, United States
Saint Luke's Cancer Institute - Twin FallsRecruiting
Twin Falls, Idaho, United States
NorthShore University HealthSystem-Evanston HospitalRecruiting
Evanston, Illinois, United States
NorthShore University HealthSystem-Glenbrook HospitalRecruiting
Glenview, Illinois, United States
NorthShore University HealthSystem-Highland Park HospitalRecruiting
Highland Park, Illinois, United States
North Shore Medical CenterRecruiting
Skokie, Illinois, United States
Alegent Health Mercy HospitalRecruiting
Council Bluffs, Iowa, United States
Flaget Memorial HospitalRecruiting
Bardstown, Kentucky, United States
Commonwealth Cancer Center-CorbinRecruiting
Corbin, Kentucky, United States
Saint Joseph HospitalRecruiting
Lexington, Kentucky, United States
Saint Joseph Radiation Oncology Resource CenterRecruiting
Lexington, Kentucky, United States
Saint Joseph Hospital EastRecruiting
Lexington, Kentucky, United States
Saint Joseph LondonRecruiting
London, Kentucky, United States
Saint Joseph Mount SterlingRecruiting
Mount Sterling, Kentucky, United States
LSU Healthcare Network / Metairie Multi-Specialty ClinicRecruiting
Metairie, Louisiana, United States
Louisiana State University Health Science CenterRecruiting
New Orleans, Louisiana, United States
Community Hospital of AnacondaRecruiting
Anaconda, Montana, United States
Billings Clinic Cancer CenterRecruiting
Billings, Montana, United States
Bozeman Deaconess HospitalRecruiting
Bozeman, Montana, United States
Benefis Healthcare- Sletten Cancer InstituteRecruiting
Great Falls, Montana, United States
Great Falls ClinicRecruiting
Great Falls, Montana, United States
Kalispell Regional Medical CenterRecruiting
Kalispell, Montana, United States
Saint Patrick Hospital - Community HospitalRecruiting
Missoula, Montana, United States
Community Medical HospitalSuspended
Missoula, Montana, United States
CHI Health Good SamaritanRecruiting
Kearney, Nebraska, United States
Saint Elizabeth Regional Medical CenterRecruiting
Lincoln, Nebraska, United States
Alegent Health Immanuel Medical CenterRecruiting
Omaha, Nebraska, United States
Alegent Health Bergan Mercy Medical CenterRecruiting
Omaha, Nebraska, United States
Alegent Health Lakeside HospitalRecruiting
Omaha, Nebraska, United States
Creighton University Medical CenterRecruiting
Omaha, Nebraska, United States
Midlands Community HospitalRecruiting
Papillion, Nebraska, United States
Garnet Health Medical CenterRecruiting
Middletown, New York, United States
Good Samaritan Hospital - CincinnatiRecruiting
Cincinnati, Ohio, United States
Bethesda North HospitalRecruiting
Cincinnati, Ohio, United States
TriHealth Cancer Institute-WestsideRecruiting
Cincinnati, Ohio, United States
TriHealth Cancer Institute-AndersonRecruiting
Cincinnati, Ohio, United States
University of Oklahoma Health Sciences CenterRecruiting
Oklahoma City, Oklahoma, United States
Saint Alphonsus Medical Center-Baker CityRecruiting
Baker City, Oregon, United States
Saint Charles Health SystemRecruiting
Bend, Oregon, United States
Clackamas Radiation Oncology CenterRecruiting
Clackamas, Oregon, United States
Providence Cancer Institute Clackamas ClinicRecruiting
Clackamas, Oregon, United States
Bay Area HospitalRecruiting
Coos Bay, Oregon, United States
Providence Newberg Medical CenterRecruiting
Newberg, Oregon, United States
Saint Alphonsus Medical Center-OntarioRecruiting
Ontario, Oregon, United States
Providence Willamette Falls Medical CenterRecruiting
Oregon City, Oregon, United States
Providence Portland Medical CenterRecruiting
Portland, Oregon, United States
Providence Saint Vincent Medical CenterRecruiting
Portland, Oregon, United States
Oregon Health and Science UniversityRecruiting
Portland, Oregon, United States
Saint Charles Health System-RedmondRecruiting
Redmond, Oregon, United States
Smilow Cancer Hospital Care Center - WesterlyRecruiting
Westerly, Rhode Island, United States
Providence Regional Cancer System-AberdeenRecruiting
Aberdeen, Washington, United States
PeaceHealth Saint Joseph Medical CenterRecruiting
Bellingham, Washington, United States
Harrison Medical CenterRecruiting
Bremerton, Washington, United States
Providence Regional Cancer System-CentraliaRecruiting
Centralia, Washington, United States
Swedish Cancer Institute-EdmondsRecruiting
Edmonds, Washington, United States
Providence Regional Cancer PartnershipRecruiting
Everett, Washington, United States
Swedish Cancer Institute-IssaquahRecruiting
Issaquah, Washington, United States
Kadlec Clinic Hematology and OncologyRecruiting
Kennewick, Washington, United States
Providence Regional Cancer System-LaceyRecruiting
Lacey, Washington, United States
PeaceHealth Saint John Medical CenterRecruiting
Longview, Washington, United States
Swedish Medical Center-Ballard CampusRecruiting
Seattle, Washington, United States
FHCC South Lake UnionRecruiting
Seattle, Washington, United States
Fred Hutchinson Cancer Research CenterRecruiting
Seattle, Washington, United States
Swedish Medical Center-Cherry HillRecruiting
Seattle, Washington, United States
Swedish Medical Center-First HillRecruiting
Seattle, Washington, United States
University of Washington Medical Center - MontlakeRecruiting
Seattle, Washington, United States
PeaceHealth United General Medical CenterRecruiting
Sedro-Woolley, Washington, United States
Providence Regional Cancer System-SheltonRecruiting
Shelton, Washington, United States
PeaceHealth Southwest Medical CenterRecruiting
Vancouver, Washington, United States
Providence Saint Mary Regional Cancer CenterRecruiting
Walla Walla, Washington, United States
Providence Regional Cancer System-YelmRecruiting
Yelm, Washington, United States
Billings Clinic-CodyRecruiting
Cody, Wyoming, United States
Welch Cancer CenterRecruiting
Sheridan, Wyoming, United States