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

Status: Recruiting
Location: See all (133) locations...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Alaska
Alaska Breast Care and Surgery LLC
RECRUITING
Anchorage
Alaska Oncology and Hematology LLC
RECRUITING
Anchorage
Alaska Women's Cancer Care
RECRUITING
Anchorage
Anchorage Associates in Radiation Medicine
RECRUITING
Anchorage
Anchorage Oncology Centre
RECRUITING
Anchorage
Anchorage Radiation Therapy Center
RECRUITING
Anchorage
Katmai Oncology Group
RECRUITING
Anchorage
Providence Alaska Medical Center
RECRUITING
Anchorage
Arizona
Cancer Center at Saint Joseph's
RECRUITING
Phoenix
California
Mission Hope Medical Oncology - Arroyo Grande
RECRUITING
Arroyo Grande
Providence Saint Joseph Medical Center/Disney Family Cancer Center
RECRUITING
Burbank
Mercy Cancer Center �� Carmichael
RECRUITING
Carmichael
Mercy San Juan Medical Center
RECRUITING
Carmichael
City of Hope Comprehensive Cancer Center
RECRUITING
Duarte
Mercy Cancer Center - Elk Grove
RECRUITING
Elk Grove
City of Hope at Irvine Lennar
RECRUITING
Irvine
Providence Queen of The Valley
RECRUITING
Napa
Mercy Cancer Center - Rocklin
RECRUITING
Rocklin
Mercy Cancer Center - Sacramento
RECRUITING
Sacramento
Pacific Central Coast Health Center-San Luis Obispo
RECRUITING
San Luis Obispo
Mission Hope Medical Oncology - Santa Maria
RECRUITING
Santa Maria
Providence Medical Foundation - Santa Rosa
RECRUITING
Santa Rosa
Providence Santa Rosa Memorial Hospital
RECRUITING
Santa Rosa
Woodland Memorial Hospital
RECRUITING
Woodland
Colorado
Penrose-Saint Francis Healthcare
RECRUITING
Colorado Springs
Rocky Mountain Cancer Centers-Penrose
RECRUITING
Colorado Springs
Saint Francis Cancer Center
RECRUITING
Colorado Springs
Porter Adventist Hospital
RECRUITING
Denver
Mercy Medical Center
RECRUITING
Durango
Southwest Oncology PC
RECRUITING
Durango
Saint Anthony Hospital
RECRUITING
Lakewood
Littleton Adventist Hospital
RECRUITING
Littleton
Longmont United Hospital
RECRUITING
Longmont
Parker Adventist Hospital
RECRUITING
Parker
Saint Mary Corwin Medical Center
RECRUITING
Pueblo
Connecticut
Smilow Cancer Hospital-Derby Care Center
RECRUITING
Derby
Smilow Cancer Hospital Care Center-Fairfield
RECRUITING
Fairfield
Smilow Cancer Hospital Care Center at Glastonbury
RECRUITING
Glastonbury
Smilow Cancer Hospital Care Center at Greenwich
RECRUITING
Greenwich
Smilow Cancer Hospital Care Center - Guilford
RECRUITING
Guilford
Smilow Cancer Hospital Care Center at Saint Francis
RECRUITING
Hartford
Smilow Cancer Center/Yale-New Haven Hospital
RECRUITING
New Haven
Yale University
RECRUITING
New Haven
Yale-New Haven Hospital North Haven Medical Center
RECRUITING
North Haven
Smilow Cancer Hospital Care Center at Long Ridge
RECRUITING
Stamford
Smilow Cancer Hospital-Torrington Care Center
RECRUITING
Torrington
Smilow Cancer Hospital Care Center-Trumbull
RECRUITING
Trumbull
Smilow Cancer Hospital-Waterbury Care Center
RECRUITING
Waterbury
Smilow Cancer Hospital Care Center - Waterford
RECRUITING
Waterford
Iowa
Alegent Health Mercy Hospital
RECRUITING
Council Bluffs
Idaho
Saint Alphonsus Cancer Care Center-Boise
RECRUITING
Boise
Saint Luke's Cancer Institute - Boise
RECRUITING
Boise
Saint Alphonsus Cancer Care Center-Caldwell
RECRUITING
Caldwell
Kootenai Health - Coeur d'Alene
RECRUITING
Coeur D'alene
Walter Knox Memorial Hospital
RECRUITING
Emmett
Saint Luke's Cancer Institute - Fruitland
RECRUITING
Fruitland
Idaho Urologic Institute-Meridian
RECRUITING
Meridian
Saint Luke's Cancer Institute - Meridian
RECRUITING
Meridian
Saint Alphonsus Cancer Care Center-Nampa
RECRUITING
Nampa
Saint Luke's Cancer Institute - Nampa
RECRUITING
Nampa
Kootenai Clinic Cancer Services - Post Falls
RECRUITING
Post Falls
Kootenai Cancer Clinic
RECRUITING
Sandpoint
Saint Luke's Cancer Institute - Twin Falls
RECRUITING
Twin Falls
Illinois
NorthShore University HealthSystem-Evanston Hospital
RECRUITING
Evanston
NorthShore University HealthSystem-Glenbrook Hospital
RECRUITING
Glenview
NorthShore University HealthSystem-Highland Park Hospital
RECRUITING
Highland Park
North Shore Medical Center
RECRUITING
Skokie
Kentucky
Flaget Memorial Hospital
RECRUITING
Bardstown
Commonwealth Cancer Center-Corbin
RECRUITING
Corbin
Saint Joseph Hospital
RECRUITING
Lexington
Saint Joseph Hospital East
RECRUITING
Lexington
Saint Joseph Radiation Oncology Resource Center
RECRUITING
Lexington
Saint Joseph London
RECRUITING
London
Saint Joseph Mount Sterling
RECRUITING
Mount Sterling
Louisiana
LSU Healthcare Network / Metairie Multi-Specialty Clinic
RECRUITING
Metairie
Louisiana State University Health Science Center
RECRUITING
New Orleans
Montana
Community Hospital of Anaconda
RECRUITING
Anaconda
Billings Clinic Cancer Center
RECRUITING
Billings
Bozeman Deaconess Hospital
RECRUITING
Bozeman
Benefis Healthcare- Sletten Cancer Institute
RECRUITING
Great Falls
Great Falls Clinic
RECRUITING
Great Falls
Kalispell Regional Medical Center
RECRUITING
Kalispell
Community Medical Hospital
SUSPENDED
Missoula
Saint Patrick Hospital - Community Hospital
RECRUITING
Missoula
Nebraska
CHI Health Good Samaritan
RECRUITING
Kearney
Saint Elizabeth Regional Medical Center
RECRUITING
Lincoln
Alegent Health Bergan Mercy Medical Center
RECRUITING
Omaha
Alegent Health Immanuel Medical Center
RECRUITING
Omaha
Alegent Health Lakeside Hospital
RECRUITING
Omaha
Creighton University Medical Center
RECRUITING
Omaha
Midlands Community Hospital
RECRUITING
Papillion
New York
Garnet Health Medical Center
RECRUITING
Middletown
Ohio
Bethesda North Hospital
RECRUITING
Cincinnati
Good Samaritan Hospital - Cincinnati
RECRUITING
Cincinnati
TriHealth Cancer Institute-Anderson
RECRUITING
Cincinnati
TriHealth Cancer Institute-Westside
RECRUITING
Cincinnati
Oklahoma
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Oregon
Saint Alphonsus Medical Center-Baker City
RECRUITING
Baker City
Saint Charles Health System
RECRUITING
Bend
Clackamas Radiation Oncology Center
RECRUITING
Clackamas
Providence Cancer Institute Clackamas Clinic
RECRUITING
Clackamas
Bay Area Hospital
RECRUITING
Coos Bay
Providence Newberg Medical Center
RECRUITING
Newberg
Saint Alphonsus Medical Center-Ontario
RECRUITING
Ontario
Providence Willamette Falls Medical Center
RECRUITING
Oregon City
Oregon Health and Science University
RECRUITING
Portland
Providence Portland Medical Center
RECRUITING
Portland
Providence Saint Vincent Medical Center
RECRUITING
Portland
Saint Charles Health System-Redmond
RECRUITING
Redmond
Rhode Island
Smilow Cancer Hospital Care Center - Westerly
RECRUITING
Westerly
Washington
Providence Regional Cancer System-Aberdeen
RECRUITING
Aberdeen
PeaceHealth Saint Joseph Medical Center
RECRUITING
Bellingham
Harrison Medical Center
RECRUITING
Bremerton
Providence Regional Cancer System-Centralia
RECRUITING
Centralia
Swedish Cancer Institute-Edmonds
RECRUITING
Edmonds
Providence Regional Cancer Partnership
RECRUITING
Everett
Swedish Cancer Institute-Issaquah
RECRUITING
Issaquah
Kadlec Clinic Hematology and Oncology
RECRUITING
Kennewick
Providence Regional Cancer System-Lacey
RECRUITING
Lacey
PeaceHealth Saint John Medical Center
RECRUITING
Longview
FHCC South Lake Union
RECRUITING
Seattle
Fred Hutchinson Cancer Research Center
RECRUITING
Seattle
Swedish Medical Center-Ballard Campus
RECRUITING
Seattle
Swedish Medical Center-Cherry Hill
RECRUITING
Seattle
Swedish Medical Center-First Hill
RECRUITING
Seattle
University of Washington Medical Center - Montlake
RECRUITING
Seattle
PeaceHealth United General Medical Center
RECRUITING
Sedro-woolley
Providence Regional Cancer System-Shelton
RECRUITING
Shelton
PeaceHealth Southwest Medical Center
RECRUITING
Vancouver
Providence Saint Mary Regional Cancer Center
RECRUITING
Walla Walla
Providence Regional Cancer System-Yelm
RECRUITING
Yelm
Wyoming
Billings Clinic-Cody
RECRUITING
Cody
Welch Cancer Center
RECRUITING
Sheridan
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2031-06
Participants
Target number of participants: 44
Treatments
Experimental: Treatment (carboplatin)
Patients receive carboplatin IV on study. Patients then undergo surgery on study. Patients who experience PSA progression after surgery undergo CT or MRI of the abdomen and pelvis, CT of the chest or chest X-ray, or PSMA-PET throughout the trial. Patients also undergo collection of blood samples throughout the trial.
Related Therapeutic Areas
Sponsors
Leads: SWOG Cancer Research Network
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov