Carboplatin Chemotherapy Before Surgery for People With High-Risk Prostate Cancer and an Inherited BRCA1 or BRCA2 Gene Mutation
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
Interventions
Biospecimen Collection
Carboplatin
Chest Radiography
Computed Tomography
Magnetic Resonance Imaging
PSMA PET Scan
Surgical Procedure
Conditions
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