Spots Global Cancer Trial Database for Carboplatin Chemotherapy Before Surgery for People With High-Risk Prostate Cancer and an Inherited BRCA1 or BRCA2 Gene Mutation
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Trial Identification
Brief Title: Carboplatin Chemotherapy Before Surgery for People With High-Risk Prostate Cancer and an Inherited BRCA1 or BRCA2 Gene Mutation
Official Title: S2210 A Phase II Study of Neoadjuvant Carboplatin for Localized, High Risk Prostate Cancer With Germline BRCA1/2 Mutations
Study ID: NCT05806515
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Anchorage Associates in Radiation Medicine, Anchorage, Alaska, United States
Anchorage Radiation Therapy Center, Anchorage, Alaska, United States
Alaska Breast Care and Surgery LLC, Anchorage, Alaska, United States
Alaska Oncology and Hematology LLC, Anchorage, Alaska, United States
Alaska Women's Cancer Care, Anchorage, Alaska, United States
Anchorage Oncology Centre, Anchorage, Alaska, United States
Katmai Oncology Group, Anchorage, Alaska, United States
Providence Alaska Medical Center, Anchorage, Alaska, United States
Cancer Center at Saint Joseph's, Phoenix, Arizona, United States
Mission Hope Medical Oncology - Arroyo Grande, Arroyo Grande, California, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank, California, United States
Mercy Cancer Center �� Carmichael, Carmichael, California, United States
Mercy San Juan Medical Center, Carmichael, California, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
Mercy Cancer Center - Elk Grove, Elk Grove, California, United States
City of Hope at Irvine Lennar, Irvine, California, United States
Providence Queen of The Valley, Napa, California, United States
Mercy Cancer Center - Rocklin, Rocklin, California, United States
Mercy Cancer Center - Sacramento, Sacramento, California, United States
Pacific Central Coast Health Center-San Luis Obispo, San Luis Obispo, California, United States
Mission Hope Medical Oncology - Santa Maria, Santa Maria, California, United States
Providence Medical Foundation - Santa Rosa, Santa Rosa, California, United States
Providence Santa Rosa Memorial Hospital, Santa Rosa, California, United States
Woodland Memorial Hospital, Woodland, California, United States
Penrose-Saint Francis Healthcare, Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers-Penrose, Colorado Springs, Colorado, United States
Saint Francis Cancer Center, Colorado Springs, Colorado, United States
Porter Adventist Hospital, Denver, Colorado, United States
Mercy Medical Center, Durango, Colorado, United States
Southwest Oncology PC, Durango, Colorado, United States
Saint Anthony Hospital, Lakewood, Colorado, United States
Littleton Adventist Hospital, Littleton, Colorado, United States
Longmont United Hospital, Longmont, Colorado, United States
Parker Adventist Hospital, Parker, Colorado, United States
Saint Mary Corwin Medical Center, Pueblo, Colorado, United States
Smilow Cancer Hospital-Derby Care Center, Derby, Connecticut, United States
Smilow Cancer Hospital Care Center-Fairfield, Fairfield, Connecticut, United States
Smilow Cancer Hospital Care Center at Glastonbury, Glastonbury, Connecticut, United States
Smilow Cancer Hospital Care Center at Greenwich, Greenwich, Connecticut, United States
Smilow Cancer Hospital Care Center - Guilford, Guilford, Connecticut, United States
Smilow Cancer Hospital Care Center at Saint Francis, Hartford, Connecticut, United States
Smilow Cancer Center/Yale-New Haven Hospital, New Haven, Connecticut, United States
Yale University, New Haven, Connecticut, United States
Yale-New Haven Hospital North Haven Medical Center, North Haven, Connecticut, United States
Smilow Cancer Hospital Care Center at Long Ridge, Stamford, Connecticut, United States
Smilow Cancer Hospital-Torrington Care Center, Torrington, Connecticut, United States
Smilow Cancer Hospital Care Center-Trumbull, Trumbull, Connecticut, United States
Smilow Cancer Hospital-Waterbury Care Center, Waterbury, Connecticut, United States
Smilow Cancer Hospital Care Center - Waterford, Waterford, Connecticut, United States
Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho, United States
Saint Luke's Cancer Institute - Boise, Boise, Idaho, United States
Saint Alphonsus Cancer Care Center-Caldwell, Caldwell, Idaho, United States
Kootenai Health - Coeur d'Alene, Coeur d'Alene, Idaho, United States
Walter Knox Memorial Hospital, Emmett, Idaho, United States
Saint Luke's Cancer Institute - Fruitland, Fruitland, Idaho, United States
Idaho Urologic Institute-Meridian, Meridian, Idaho, United States
Saint Luke's Cancer Institute - Meridian, Meridian, Idaho, United States
Saint Luke's Cancer Institute - Nampa, Nampa, Idaho, United States
Saint Alphonsus Cancer Care Center-Nampa, Nampa, Idaho, United States
Kootenai Clinic Cancer Services - Post Falls, Post Falls, Idaho, United States
Kootenai Cancer Clinic, Sandpoint, Idaho, United States
Saint Luke's Cancer Institute - Twin Falls, Twin Falls, Idaho, United States
NorthShore University HealthSystem-Evanston Hospital, Evanston, Illinois, United States
NorthShore University HealthSystem-Glenbrook Hospital, Glenview, Illinois, United States
NorthShore University HealthSystem-Highland Park Hospital, Highland Park, Illinois, United States
North Shore Medical Center, Skokie, Illinois, United States
Alegent Health Mercy Hospital, Council Bluffs, Iowa, United States
Flaget Memorial Hospital, Bardstown, Kentucky, United States
Commonwealth Cancer Center-Corbin, Corbin, Kentucky, United States
Saint Joseph Hospital, Lexington, Kentucky, United States
Saint Joseph Radiation Oncology Resource Center, Lexington, Kentucky, United States
Saint Joseph Hospital East, Lexington, Kentucky, United States
Saint Joseph London, London, Kentucky, United States
Saint Joseph Mount Sterling, Mount Sterling, Kentucky, United States
LSU Healthcare Network / Metairie Multi-Specialty Clinic, Metairie, Louisiana, United States
Louisiana State University Health Science Center, New Orleans, Louisiana, United States
Community Hospital of Anaconda, Anaconda, Montana, United States
Billings Clinic Cancer Center, Billings, Montana, United States
Bozeman Deaconess Hospital, Bozeman, Montana, United States
Benefis Healthcare- Sletten Cancer Institute, Great Falls, Montana, United States
Great Falls Clinic, Great Falls, Montana, United States
Kalispell Regional Medical Center, Kalispell, Montana, United States
Saint Patrick Hospital - Community Hospital, Missoula, Montana, United States
Community Medical Hospital, Missoula, Montana, United States
CHI Health Good Samaritan, Kearney, Nebraska, United States
Saint Elizabeth Regional Medical Center, Lincoln, Nebraska, United States
Alegent Health Immanuel Medical Center, Omaha, Nebraska, United States
Alegent Health Bergan Mercy Medical Center, Omaha, Nebraska, United States
Alegent Health Lakeside Hospital, Omaha, Nebraska, United States
Creighton University Medical Center, Omaha, Nebraska, United States
Midlands Community Hospital, Papillion, Nebraska, United States
Garnet Health Medical Center, Middletown, New York, United States
Good Samaritan Hospital - Cincinnati, Cincinnati, Ohio, United States
Bethesda North Hospital, Cincinnati, Ohio, United States
TriHealth Cancer Institute-Westside, Cincinnati, Ohio, United States
TriHealth Cancer Institute-Anderson, Cincinnati, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Saint Alphonsus Medical Center-Baker City, Baker City, Oregon, United States
Saint Charles Health System, Bend, Oregon, United States
Clackamas Radiation Oncology Center, Clackamas, Oregon, United States
Providence Cancer Institute Clackamas Clinic, Clackamas, Oregon, United States
Bay Area Hospital, Coos Bay, Oregon, United States
Providence Newberg Medical Center, Newberg, Oregon, United States
Saint Alphonsus Medical Center-Ontario, Ontario, Oregon, United States
Providence Willamette Falls Medical Center, Oregon City, Oregon, United States
Providence Portland Medical Center, Portland, Oregon, United States
Providence Saint Vincent Medical Center, Portland, Oregon, United States
Oregon Health and Science University, Portland, Oregon, United States
Saint Charles Health System-Redmond, Redmond, Oregon, United States
Smilow Cancer Hospital Care Center - Westerly, Westerly, Rhode Island, United States
Providence Regional Cancer System-Aberdeen, Aberdeen, Washington, United States
PeaceHealth Saint Joseph Medical Center, Bellingham, Washington, United States
Harrison Medical Center, Bremerton, Washington, United States
Providence Regional Cancer System-Centralia, Centralia, Washington, United States
Swedish Cancer Institute-Edmonds, Edmonds, Washington, United States
Providence Regional Cancer Partnership, Everett, Washington, United States
Swedish Cancer Institute-Issaquah, Issaquah, Washington, United States
Kadlec Clinic Hematology and Oncology, Kennewick, Washington, United States
Providence Regional Cancer System-Lacey, Lacey, Washington, United States
PeaceHealth Saint John Medical Center, Longview, Washington, United States
Swedish Medical Center-Ballard Campus, Seattle, Washington, United States
FHCC South Lake Union, Seattle, Washington, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Swedish Medical Center-Cherry Hill, Seattle, Washington, United States
Swedish Medical Center-First Hill, Seattle, Washington, United States
University of Washington Medical Center - Montlake, Seattle, Washington, United States
PeaceHealth United General Medical Center, Sedro-Woolley, Washington, United States
Providence Regional Cancer System-Shelton, Shelton, Washington, United States
PeaceHealth Southwest Medical Center, Vancouver, Washington, United States
Providence Saint Mary Regional Cancer Center, Walla Walla, Washington, United States
Providence Regional Cancer System-Yelm, Yelm, Washington, United States
Billings Clinic-Cody, Cody, Wyoming, United States
Welch Cancer Center, Sheridan, Wyoming, United States
Contact Details
Name: Heather H Cheng
Affiliation: SWOG Cancer Research Network
Role: PRINCIPAL_INVESTIGATOR
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