S2210 A Phase II Study of Neoadjuvant Carboplatin for Localized, High Risk Prostate Cancer With Germline BRCA1/2 Mutations
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.
Arms & interventions
- ProcedureBiospecimen Collection
Undergo collection of blood samples
- DrugCarboplatin
Given IV
- ProcedureChest Radiography
Undergo chest X-ray
- ProcedureComputed Tomography
Undergo CT
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- ProcedurePSMA PET Scan
Undergo PSMA PET
- ProcedureSurgical Procedure
Undergo surgery
Outcome measures
Primary
Pathologic complete response after neoadjuvant carboplatin
A two-stage design will be used.
Time frame: Up to 5 years
Eligibility criteria
Study locations (133)
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508
Anchorage Radiation Therapy Center
Anchorage, Alaska, 99504
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
Alaska Women's Cancer Care
Anchorage, Alaska, 99508
Anchorage Oncology Centre
Anchorage, Alaska, 99508
Katmai Oncology Group
Anchorage, Alaska, 99508
Providence Alaska Medical Center
Anchorage, Alaska, 99508
Cancer Center at Saint Joseph's
Phoenix, Arizona, 85004
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, 93420
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505
Mercy Cancer Center �� Carmichael
Carmichael, California, 95608
Mercy San Juan Medical Center
Carmichael, California, 95608
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Mercy Cancer Center - Elk Grove
Elk Grove, California, 95758
City of Hope at Irvine Lennar
Irvine, California, 92618
Providence Queen of The Valley
Napa, California, 94558
Mercy Cancer Center - Rocklin
Rocklin, California, 95765
Mercy Cancer Center - Sacramento
Sacramento, California, 95816
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California, 93401
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California, 93444
Providence Medical Foundation - Santa Rosa
Santa Rosa, California, 95403
Providence Santa Rosa Memorial Hospital
Santa Rosa, California, 95405
Woodland Memorial Hospital
Woodland, California, 95695
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907
Saint Francis Cancer Center
Colorado Springs, Colorado, 80923
Porter Adventist Hospital
Denver, Colorado, 80210
Mercy Medical Center
Durango, Colorado, 81301
Southwest Oncology PC
Durango, Colorado, 81301
Saint Anthony Hospital
Lakewood, Colorado, 80228
Littleton Adventist Hospital
Littleton, Colorado, 80122
Longmont United Hospital
Longmont, Colorado, 80501
Parker Adventist Hospital
Parker, Colorado, 80138
Saint Mary Corwin Medical Center
Pueblo, Colorado, 81004
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, 06418
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, 06824
Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut, 06033
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, 06830
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, 06437
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut, 06510
Yale University
New Haven, Connecticut, 06520
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, 06473
Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut, 06902
Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut, 06790
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, 06611
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut, 06708
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, 06385
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Walter Knox Memorial Hospital
Emmett, Idaho, 83617
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
Idaho Urologic Institute-Meridian
Meridian, Idaho, 83642
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83686
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854
Kootenai Cancer Clinic
Sandpoint, Idaho, 83864
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, 83301
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, 60026
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, 60035
North Shore Medical Center
Skokie, Illinois, 60076
Alegent Health Mercy Hospital
Council Bluffs, Iowa, 51503
Flaget Memorial Hospital
Bardstown, Kentucky, 40004
Commonwealth Cancer Center-Corbin
Corbin, Kentucky, 40701
Saint Joseph Hospital
Lexington, Kentucky, 40504
Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky, 40504
Saint Joseph Hospital East
Lexington, Kentucky, 40509
Saint Joseph London
London, Kentucky, 40741
Saint Joseph Mount Sterling
Mount Sterling, Kentucky, 40353
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie, Louisiana, 70006
Louisiana State University Health Science Center
New Orleans, Louisiana, 70112
Community Hospital of Anaconda
Anaconda, Montana, 59711
Billings Clinic Cancer Center
Billings, Montana, 59101
Bozeman Deaconess Hospital
Bozeman, Montana, 59715
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, 59405
Great Falls Clinic
Great Falls, Montana, 59405
Kalispell Regional Medical Center
Kalispell, Montana, 59901
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802
Community Medical Hospital
Missoula, Montana, 59804
CHI Health Good Samaritan
Kearney, Nebraska, 68847
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska, 68510
Alegent Health Immanuel Medical Center
Omaha, Nebraska, 68122
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, 68124
Alegent Health Lakeside Hospital
Omaha, Nebraska, 68130
Creighton University Medical Center
Omaha, Nebraska, 68131
Midlands Community Hospital
Papillion, Nebraska, 68046
Garnet Health Medical Center
Middletown, New York, 10940
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
Bethesda North Hospital
Cincinnati, Ohio, 45242
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, 45247
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio, 45255
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Saint Alphonsus Medical Center-Baker City
Baker City, Oregon, 97814
Saint Charles Health System
Bend, Oregon, 97701
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015
Bay Area Hospital
Coos Bay, Oregon, 97420
Providence Newberg Medical Center
Newberg, Oregon, 97132
Saint Alphonsus Medical Center-Ontario
Ontario, Oregon, 97914
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045
Providence Portland Medical Center
Portland, Oregon, 97213
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
Oregon Health and Science University
Portland, Oregon, 97239
Saint Charles Health System-Redmond
Redmond, Oregon, 97756
Smilow Cancer Hospital Care Center - Westerly
Westerly, Rhode Island, 02891
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, 98520
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
Harrison Medical Center
Bremerton, Washington, 98310
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
Providence Regional Cancer Partnership
Everett, Washington, 98201
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336
Providence Regional Cancer System-Lacey
Lacey, Washington, 98503
PeaceHealth Saint John Medical Center
Longview, Washington, 98632
Swedish Medical Center-Ballard Campus
Seattle, Washington, 98107
FHCC South Lake Union
Seattle, Washington, 98109
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Swedish Medical Center-Cherry Hill
Seattle, Washington, 98122-5711
Swedish Medical Center-First Hill
Seattle, Washington, 98122
University of Washington Medical Center - Montlake
Seattle, Washington, 98195
PeaceHealth United General Medical Center
Sedro-Woolley, Washington, 98284
Providence Regional Cancer System-Shelton
Shelton, Washington, 98584
PeaceHealth Southwest Medical Center
Vancouver, Washington, 98664
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, 99362
Providence Regional Cancer System-Yelm
Yelm, Washington, 98597
Billings Clinic-Cody
Cody, Wyoming, 82414
Welch Cancer Center
Sheridan, Wyoming, 82801