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

RecruitingPhase 2

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

Who can join

Ages 18 and older · Men

Full 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

About the study

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.

What is being tested

Sponsor: SWOG Cancer Research Network · Participants: 44 · Started: Mar 1, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT05806515

Locations in the U.S.

AlaskaAlaska Breast Care and Surgery LLC, Anchorage
Alaska Oncology and Hematology LLC, Anchorage
Alaska Women's Cancer Care, Anchorage
Anchorage Associates in Radiation Medicine, Anchorage
Anchorage Oncology Centre, Anchorage
Anchorage Radiation Therapy Center, Anchorage
Katmai Oncology Group, Anchorage
Providence Alaska Medical Center, Anchorage
ArizonaCancer Center at Saint Joseph's, Phoenix
CaliforniaMission Hope Medical Oncology - Arroyo Grande, Arroyo Grande
Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank
Mercy Cancer Center �� Carmichael, Carmichael
Mercy San Juan Medical Center, Carmichael
City of Hope Comprehensive Cancer Center, Duarte
Mercy Cancer Center - Elk Grove, Elk Grove
City of Hope at Irvine Lennar, Irvine
Providence Queen of The Valley, Napa
Mercy Cancer Center - Rocklin, Rocklin
Mercy Cancer Center - Sacramento, Sacramento
Pacific Central Coast Health Center-San Luis Obispo, San Luis Obispo
Mission Hope Medical Oncology - Santa Maria, Santa Maria
Providence Medical Foundation - Santa Rosa, Santa Rosa
Providence Santa Rosa Memorial Hospital, Santa Rosa
Woodland Memorial Hospital, Woodland
ColoradoPenrose-Saint Francis Healthcare, Colorado Springs
Rocky Mountain Cancer Centers-Penrose, Colorado Springs
Saint Francis Cancer Center, Colorado Springs
Porter Adventist Hospital, Denver
Mercy Medical Center, Durango
Southwest Oncology PC, Durango
Saint Anthony Hospital, Lakewood
Littleton Adventist Hospital, Littleton
Longmont United Hospital, Longmont
Parker Adventist Hospital, Parker
Saint Mary Corwin Medical Center, Pueblo
ConnecticutSmilow Cancer Hospital-Derby Care Center, Derby
Smilow Cancer Hospital Care Center-Fairfield, Fairfield
Smilow Cancer Hospital Care Center at Glastonbury, Glastonbury
Smilow Cancer Hospital Care Center at Greenwich, Greenwich
Smilow Cancer Hospital Care Center - Guilford, Guilford
Smilow Cancer Hospital Care Center at Saint Francis, Hartford
Smilow Cancer Center/Yale-New Haven Hospital, New Haven
Yale University, New Haven
Yale-New Haven Hospital North Haven Medical Center, North Haven
Smilow Cancer Hospital Care Center at Long Ridge, Stamford
Smilow Cancer Hospital-Torrington Care Center, Torrington
Smilow Cancer Hospital Care Center-Trumbull, Trumbull
Smilow Cancer Hospital-Waterbury Care Center, Waterbury
Smilow Cancer Hospital Care Center - Waterford, Waterford
IdahoSaint Alphonsus Cancer Care Center-Boise, Boise
Saint Luke's Cancer Institute - Boise, Boise
Saint Alphonsus Cancer Care Center-Caldwell, Caldwell
Kootenai Health - Coeur d'Alene, Coeur d'Alene
Walter Knox Memorial Hospital, Emmett
Saint Luke's Cancer Institute - Fruitland, Fruitland
Idaho Urologic Institute-Meridian, Meridian
Saint Luke's Cancer Institute - Meridian, Meridian
Saint Alphonsus Cancer Care Center-Nampa, Nampa
Saint Luke's Cancer Institute - Nampa, Nampa
Kootenai Clinic Cancer Services - Post Falls, Post Falls
Kootenai Cancer Clinic, Sandpoint
Saint Luke's Cancer Institute - Twin Falls, Twin Falls
IllinoisNorthShore University HealthSystem-Evanston Hospital, Evanston
NorthShore University HealthSystem-Glenbrook Hospital, Glenview
NorthShore University HealthSystem-Highland Park Hospital, Highland Park
North Shore Medical Center, Skokie
IowaAlegent Health Mercy Hospital, Council Bluffs
KentuckyFlaget Memorial Hospital, Bardstown
Commonwealth Cancer Center-Corbin, Corbin
Saint Joseph Hospital, Lexington
Saint Joseph Hospital East, Lexington
Saint Joseph Radiation Oncology Resource Center, Lexington
Saint Joseph London, London
Saint Joseph Mount Sterling, Mount Sterling
LouisianaLSU Healthcare Network / Metairie Multi-Specialty Clinic, Metairie
Louisiana State University Health Science Center, New Orleans
MontanaCommunity Hospital of Anaconda, Anaconda
Billings Clinic Cancer Center, Billings
Bozeman Deaconess Hospital, Bozeman
Benefis Healthcare- Sletten Cancer Institute, Great Falls
Great Falls Clinic, Great Falls
Kalispell Regional Medical Center, Kalispell
Saint Patrick Hospital - Community Hospital, Missoula
NebraskaCHI Health Good Samaritan, Kearney
Saint Elizabeth Regional Medical Center, Lincoln
Alegent Health Bergan Mercy Medical Center, Omaha
Alegent Health Immanuel Medical Center, Omaha
Alegent Health Lakeside Hospital, Omaha
Creighton University Medical Center, Omaha
Midlands Community Hospital, Papillion
New YorkGarnet Health Medical Center, Middletown
OhioBethesda North Hospital, Cincinnati
Good Samaritan Hospital - Cincinnati, Cincinnati
TriHealth Cancer Institute-Anderson, Cincinnati
TriHealth Cancer Institute-Westside, Cincinnati
OklahomaUniversity of Oklahoma Health Sciences Center, Oklahoma City
OregonSaint Alphonsus Medical Center-Baker City, Baker City
Saint Charles Health System, Bend
Clackamas Radiation Oncology Center, Clackamas
Providence Cancer Institute Clackamas Clinic, Clackamas
Bay Area Hospital, Coos Bay
Providence Newberg Medical Center, Newberg
Saint Alphonsus Medical Center-Ontario, Ontario
Providence Willamette Falls Medical Center, Oregon City
Oregon Health and Science University, Portland
Providence Portland Medical Center, Portland
Providence Saint Vincent Medical Center, Portland
Saint Charles Health System-Redmond, Redmond
Rhode IslandSmilow Cancer Hospital Care Center - Westerly, Westerly
WashingtonProvidence Regional Cancer System-Aberdeen, Aberdeen
PeaceHealth Saint Joseph Medical Center, Bellingham
Harrison Medical Center, Bremerton
Providence Regional Cancer System-Centralia, Centralia
Swedish Cancer Institute-Edmonds, Edmonds
Providence Regional Cancer Partnership, Everett
Swedish Cancer Institute-Issaquah, Issaquah
Kadlec Clinic Hematology and Oncology, Kennewick
Providence Regional Cancer System-Lacey, Lacey
PeaceHealth Saint John Medical Center, Longview
FHCC South Lake Union, Seattle
Fred Hutchinson Cancer Research Center, Seattle
Swedish Medical Center-Ballard Campus, Seattle
Swedish Medical Center-Cherry Hill, Seattle
Swedish Medical Center-First Hill, Seattle
University of Washington Medical Center - Montlake, Seattle
PeaceHealth United General Medical Center, Sedro-Woolley
Providence Regional Cancer System-Shelton, Shelton
PeaceHealth Southwest Medical Center, Vancouver
Providence Saint Mary Regional Cancer Center, Walla Walla
Providence Regional Cancer System-Yelm, Yelm
WyomingBillings Clinic-Cody, Cody
Welch Cancer Center, Sheridan

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.