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NCT05806515PHASE2Recruiting

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

SWOG Cancer Research Network

Start Date

3/1/2024

Completion Date

6/1/2031

Summary

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.

Detailed Description

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

Age Range: 18 years to No maximum

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

Interventions

PROCEDURE

Biospecimen Collection

DRUG

Carboplatin

PROCEDURE

Chest Radiography

PROCEDURE

Computed Tomography

PROCEDURE

Magnetic Resonance Imaging

PROCEDURE

PSMA PET Scan

PROCEDURE

Surgical Procedure

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Conditions

Prostate AdenocarcinomaStage IIIB Prostate Cancer AJCC v8Stage IIIC Prostate Cancer AJCC v8

Locations

Anchorage Associates in Radiation Medicine

Anchorage, Alaska 98508

United States

Anchorage Radiation Therapy Center

Anchorage, Alaska 99504

United States

Alaska Breast Care and Surgery LLC

Anchorage, Alaska 99508

United States

Alaska Oncology and Hematology LLC

Anchorage, Alaska 99508

United States

Alaska Women's Cancer Care

Anchorage, Alaska 99508

United States

Anchorage Oncology Centre

Anchorage, Alaska 99508

United States

Katmai Oncology Group

Anchorage, Alaska 99508

United States

Providence Alaska Medical Center

Anchorage, Alaska 99508

United States

Cancer Center at Saint Joseph's

Phoenix, Arizona 85004

United States

Mission Hope Medical Oncology - Arroyo Grande

Arroyo Grande, California 93420

United States

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California 91505

United States

Mercy Cancer Center �� Carmichael

Carmichael, California 95608

United States

Mercy San Juan Medical Center

Carmichael, California 95608

United States

City of Hope Comprehensive Cancer Center

Duarte, California 91010

United States

Mercy Cancer Center - Elk Grove

Elk Grove, California 95758

United States

City of Hope at Irvine Lennar

Irvine, California 92618

United States

Providence Queen of The Valley

Napa, California 94558

United States

Mercy Cancer Center - Rocklin

Rocklin, California 95765

United States

Mercy Cancer Center - Sacramento

Sacramento, California 95816

United States

Pacific Central Coast Health Center-San Luis Obispo

San Luis Obispo, California 93401

United States

Mission Hope Medical Oncology - Santa Maria

Santa Maria, California 93444

United States

Providence Medical Foundation - Santa Rosa

Santa Rosa, California 95403

United States

Providence Santa Rosa Memorial Hospital

Santa Rosa, California 95405

United States

Woodland Memorial Hospital

Woodland, California 95695

United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado 80907

United States

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado 80907

United States

Saint Francis Cancer Center

Colorado Springs, Colorado 80923

United States

Porter Adventist Hospital

Denver, Colorado 80210

United States

Mercy Medical Center

Durango, Colorado 81301

United States

Southwest Oncology PC

Durango, Colorado 81301

United States

Saint Anthony Hospital

Lakewood, Colorado 80228

United States

Littleton Adventist Hospital

Littleton, Colorado 80122

United States

Longmont United Hospital

Longmont, Colorado 80501

United States

Parker Adventist Hospital

Parker, Colorado 80138

United States

Saint Mary Corwin Medical Center

Pueblo, Colorado 81004

United States

Smilow Cancer Hospital-Derby Care Center

Derby, Connecticut 06418

United States

Smilow Cancer Hospital Care Center-Fairfield

Fairfield, Connecticut 06824

United States

Smilow Cancer Hospital Care Center at Glastonbury

Glastonbury, Connecticut 06033

United States

Smilow Cancer Hospital Care Center at Greenwich

Greenwich, Connecticut 06830

United States

Smilow Cancer Hospital Care Center - Guilford

Guilford, Connecticut 06437

United States

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut 06105

United States

Smilow Cancer Center/Yale-New Haven Hospital

New Haven, Connecticut 06510

United States

Yale University

New Haven, Connecticut 06520

United States

Yale-New Haven Hospital North Haven Medical Center

North Haven, Connecticut 06473

United States

Smilow Cancer Hospital Care Center at Long Ridge

Stamford, Connecticut 06902

United States

Smilow Cancer Hospital-Torrington Care Center

Torrington, Connecticut 06790

United States

Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut 06611

United States

Smilow Cancer Hospital-Waterbury Care Center

Waterbury, Connecticut 06708

United States

Smilow Cancer Hospital Care Center - Waterford

Waterford, Connecticut 06385

United States

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho 83706

United States

Saint Luke's Cancer Institute - Boise

Boise, Idaho 83712

United States

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho 83605

United States

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho 83814

United States

Walter Knox Memorial Hospital

Emmett, Idaho 83617

United States

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho 83619

United States

Idaho Urologic Institute-Meridian

Meridian, Idaho 83642

United States

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho 83642

United States

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho 83686

United States

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho 83687

United States

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho 83854

United States

Kootenai Cancer Clinic

Sandpoint, Idaho 83864

United States

Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho 83301

United States

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois 60201

United States

NorthShore University HealthSystem-Glenbrook Hospital

Glenview, Illinois 60026

United States

NorthShore University HealthSystem-Highland Park Hospital

Highland Park, Illinois 60035

United States

North Shore Medical Center

Skokie, Illinois 60076

United States

Alegent Health Mercy Hospital

Council Bluffs, Iowa 51503

United States

Flaget Memorial Hospital

Bardstown, Kentucky 40004

United States

Commonwealth Cancer Center-Corbin

Corbin, Kentucky 40701

United States

Saint Joseph Hospital

Lexington, Kentucky 40504

United States

Saint Joseph Radiation Oncology Resource Center

Lexington, Kentucky 40504

United States

Saint Joseph Hospital East

Lexington, Kentucky 40509

United States

Saint Joseph London

London, Kentucky 40741

United States

Saint Joseph Mount Sterling

Mount Sterling, Kentucky 40353

United States

LSU Healthcare Network / Metairie Multi-Specialty Clinic

Metairie, Louisiana 70006

United States

Louisiana State University Health Science Center

New Orleans, Louisiana 70112

United States

Community Hospital of Anaconda

Anaconda, Montana 59711

United States

Billings Clinic Cancer Center

Billings, Montana 59101

United States

Bozeman Deaconess Hospital

Bozeman, Montana 59715

United States

Benefis Healthcare- Sletten Cancer Institute

Great Falls, Montana 59405

United States

Great Falls Clinic

Great Falls, Montana 59405

United States

Kalispell Regional Medical Center

Kalispell, Montana 59901

United States

Saint Patrick Hospital - Community Hospital

Missoula, Montana 59802

United States

Community Medical Hospital

Missoula, Montana 59804

United States

CHI Health Good Samaritan

Kearney, Nebraska 68847

United States

Saint Elizabeth Regional Medical Center

Lincoln, Nebraska 68510

United States

Alegent Health Immanuel Medical Center

Omaha, Nebraska 68122

United States

Alegent Health Bergan Mercy Medical Center

Omaha, Nebraska 68124

United States

Alegent Health Lakeside Hospital

Omaha, Nebraska 68130

United States

Creighton University Medical Center

Omaha, Nebraska 68131

United States

Midlands Community Hospital

Papillion, Nebraska 68046

United States

Garnet Health Medical Center

Middletown, New York 10940

United States

Good Samaritan Hospital - Cincinnati

Cincinnati, Ohio 45220

United States

Bethesda North Hospital

Cincinnati, Ohio 45242

United States

TriHealth Cancer Institute-Westside

Cincinnati, Ohio 45247

United States

TriHealth Cancer Institute-Anderson

Cincinnati, Ohio 45255

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma 73104

United States

Saint Alphonsus Medical Center-Baker City

Baker City, Oregon 97814

United States

Saint Charles Health System

Bend, Oregon 97701

United States

Clackamas Radiation Oncology Center

Clackamas, Oregon 97015

United States

Providence Cancer Institute Clackamas Clinic

Clackamas, Oregon 97015

United States

Bay Area Hospital

Coos Bay, Oregon 97420

United States

Providence Newberg Medical Center

Newberg, Oregon 97132

United States

Saint Alphonsus Medical Center-Ontario

Ontario, Oregon 97914

United States

Providence Willamette Falls Medical Center

Oregon City, Oregon 97045

United States

Providence Portland Medical Center

Portland, Oregon 97213

United States

Providence Saint Vincent Medical Center

Portland, Oregon 97225

United States

Oregon Health and Science University

Portland, Oregon 97239

United States

Saint Charles Health System-Redmond

Redmond, Oregon 97756

United States

Smilow Cancer Hospital Care Center - Westerly

Westerly, Rhode Island 02891

United States

Providence Regional Cancer System-Aberdeen

Aberdeen, Washington 98520

United States

PeaceHealth Saint Joseph Medical Center

Bellingham, Washington 98225

United States

Harrison Medical Center

Bremerton, Washington 98310

United States

Providence Regional Cancer System-Centralia

Centralia, Washington 98531

United States

Swedish Cancer Institute-Edmonds

Edmonds, Washington 98026

United States

Providence Regional Cancer Partnership

Everett, Washington 98201

United States

Swedish Cancer Institute-Issaquah

Issaquah, Washington 98029

United States

Kadlec Clinic Hematology and Oncology

Kennewick, Washington 99336

United States

Providence Regional Cancer System-Lacey

Lacey, Washington 98503

United States

PeaceHealth Saint John Medical Center

Longview, Washington 98632

United States

Swedish Medical Center-Ballard Campus

Seattle, Washington 98107

United States

FHCC South Lake Union

Seattle, Washington 98109

United States

Fred Hutchinson Cancer Research Center

Seattle, Washington 98109

United States

Swedish Medical Center-Cherry Hill

Seattle, Washington 98122-5711

United States

Swedish Medical Center-First Hill

Seattle, Washington 98122

United States

University of Washington Medical Center - Montlake

Seattle, Washington 98195

United States

PeaceHealth United General Medical Center

Sedro-Woolley, Washington 98284

United States

Providence Regional Cancer System-Shelton

Shelton, Washington 98584

United States

PeaceHealth Southwest Medical Center

Vancouver, Washington 98664

United States

Providence Saint Mary Regional Cancer Center

Walla Walla, Washington 99362

United States

Providence Regional Cancer System-Yelm

Yelm, Washington 98597

United States

Billings Clinic-Cody

Cody, Wyoming 82414

United States

Welch Cancer Center

Sheridan, Wyoming 82801

United States