RECRUITING

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

Conditions

Prostate Adenocarcinoma Stage IIIB Prostate Cancer AJCC v8 Stage IIIC Prostate Cancer AJCC v8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

S2210 A Phase II Study of Neoadjuvant Carboplatin for Localized, High Risk Prostate Cancer With Germline BRCA1/2 Mutations

Quick Facts

Study Start:2024-03-01

Study Completion:2028-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05806515

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Heather H Cheng

PRINCIPAL_INVESTIGATOR

SWOG Cancer Research Network

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: SWOG Cancer Research Network

Heather H Cheng, PRINCIPAL_INVESTIGATOR, SWOG Cancer Research Network

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-01

Study Completion Date2028-06

Study Record Updates

Study Start Date2024-03-01

Study Completion Date2028-06

Terms related to this study

Additional Relevant MeSH Terms

Prostate Adenocarcinoma
Stage IIIB Prostate Cancer AJCC v8
Stage IIIC Prostate Cancer AJCC v8