Carboplatin Chemotherapy before Surgery for Patients with High-Risk Prostate Cancer and an Inherited BRCA1 or BRCA2 Gene Mutation
Clinicaltrials.gov identifier:
NCT05806515
Treatment
Treatment before surgery for people with high-risk prostate cancer and an inherited BRCA1 or BRCA2 gene mutation
Study Contact Information:
Primary Investigator: Heather H. Cheng, MD PhD
Call 1-800-4-Cancer (ask about S2210)
Carboplatin Chemotherapy before Surgery for Patients with High-Risk Prostate Cancer and an Inherited BRCA1 or BRCA2 Gene Mutation
About the Study
This study tests the effectiveness of taking the medication carboplatin between cancer diagnosis and surgery to remove the . Carboplatin works by killing, stopping, or slowing the growth of tumor cells. After surgery participants will follow up with the study team over three years to answer questions about their medical history since surgery.
What the Study Involves
The carboplatin is given intravenously (injected into the vein), once every 3 weeks for up to 4 doses. Then, surgery to remove the will be performed and the study team will follow how the participant does with a few more visits until 3 years after surgery.
Participants will be asked to bank a tissue sample from the removal for use in future studies, but this is not a requirement to participate. Participants also undergo collection of blood samples throughout the trial.
PRIMARY OBJECTIVE:
- To check how effective carboplatin treatment is for patients with aggressive cancer who have or gene mutations. We'll do this by looking at the records of patients who had surgery after receiving this treatment to see if they had a complete response.
SECONDARY OBJECTIVES:
- To evaluate how long patients stay free from specific antigen () progression after surgery, both overall and specifically, at the 3-year landmark.
- To evaluate how long patients live without their cancer spreading to other parts of their body (metastases) as well as their overall survival.
- To evaluate how often and how severe the side effects are for patients who get carboplatin treatment before having their removed surgically.
BANKING OBJECTIVE:
- To bank (save) samples for later studies that will help us understand more about cancer.
Lead Researchers/Study PIs and Affiliation
Lead Organization SWOG
Principal Investigator Heather H. Cheng, MD PhD
Alaska
City: Anchorage RECRUITING
Facility: Anchorage Associates in Radiation Medicine
Contact Info:
[email protected]
907-212-6871
Charles W. Drescher
City: Anchorage RECRUITING
Facility: Anchorage Radiation Therapy Center
Contact Info:
[email protected]
907-212-6871
Charles W. Drescher
City: Anchorage RECRUITING
Facility: Alaska Breast Care and Surgery LLC
Contact Info:
[email protected]
907-212-6871
Charles W. Drescher
City: Anchorage RECRUITING
Facility: Alaska Oncology and Hematology LLC
Contact Info:
[email protected]
907-212-6871
Charles W. Drescher
City: Anchorage RECRUITING
Facility: Alaska Women's Cancer Care
Contact Info:
[email protected]
907-212-6871
Charles W. Drescher
City: Anchorage RECRUITING
Facility: Anchorage Oncology Centre
Contact Info:
[email protected]
907-212-6871
Charles W. Drescher
City: Anchorage RECRUITING
Facility: Katmai Oncology Group
Contact Info:
[email protected]
907-212-6871
Charles W. Drescher
City: Anchorage RECRUITING
Facility: Providence Alaska Medical Center
Contact Info:
[email protected]
907-212-6871
Charles W. Drescher
Arizona
City: Phoenix RECRUITING
Facility: Cancer Center at Saint Joseph's
Contact Info:
[email protected]
602-406-0777
Shahzad Siddique
California
City: Arroyo Grande RECRUITING
Facility: Mission Hope Medical Oncology - Arroyo Grande
Contact Info:
[email protected]
805-219-4673
Shahzad Siddique
City: Burbank RECRUITING
Facility: Providence Saint Joseph Medical Center/Disney Family Cancer Center
Contact Info:
[email protected]
818-847-4793
Charles W. Drescher
City: Carmichael RECRUITING
Facility: Mercy Cancer Center �� Carmichael
Contact Info:
[email protected]
Shahzad Siddique
City: Carmichael RECRUITING
Facility: Mercy San Juan Medical Center
Contact Info:
[email protected]
916-556-3301
Shahzad Siddique
City: Duarte RECRUITING
Facility: City of Hope Comprehensive Cancer Center
Contact Info:
[email protected]
800-826-4673
Wesley Yip
City: Elk Grove RECRUITING
Facility: Mercy Cancer Center - Elk Grove
Contact Info:
[email protected]
916-556-3301
Shahzad Siddique
City: Irvine RECRUITING
Facility: City of Hope at Irvine Lennar
Contact Info:
877-467-3411
Wesley Yip
City: Napa RECRUITING
Facility: Providence Queen of The Valley
Contact Info:
707-521-3830
Charles W. Drescher
City: Rocklin RECRUITING
Facility: Mercy Cancer Center - Rocklin
Contact Info:
[email protected]
916-556-3301
Shahzad Siddique
City: Sacramento RECRUITING
Facility: Mercy Cancer Center - Sacramento
Contact Info:
[email protected]
916-556-3301
Shahzad Siddique
City: San Luis Obispo RECRUITING
Facility: Pacific Central Coast Health Center-San Luis Obispo
Contact Info:
[email protected]
805-219-4673
Shahzad Siddique
City: Santa Maria RECRUITING
Facility: Mission Hope Medical Oncology - Santa Maria
Contact Info:
[email protected]
805-219-4673
Shahzad Siddique
City: Santa Rosa RECRUITING
Facility: Providence Medical Foundation - Santa Rosa
Contact Info:
707-521-3830
Charles W. Drescher
City: Santa Rosa RECRUITING
Facility: Providence Santa Rosa Memorial Hospital
Contact Info:
707-521-3830
Charles W. Drescher
City: Woodland RECRUITING
Facility: Woodland Memorial Hospital
Contact Info:
[email protected]
916-556-3301
Shahzad Siddique
Colorado
City: Colorado Springs RECRUITING
Facility: Penrose-Saint Francis Healthcare
Contact Info:
[email protected]
719-776-6550
Shahzad Siddique
City: Colorado Springs RECRUITING
Facility: Rocky Mountain Cancer Centers-Penrose
Contact Info:
[email protected]
719-776-6550
Shahzad Siddique
City: Colorado Springs RECRUITING
Facility: Saint Francis Cancer Center
Contact Info:
[email protected]
719-776-6550
Shahzad Siddique
City: Denver RECRUITING
Facility: Porter Adventist Hospital
Contact Info:
[email protected]
719-776-6550
Shahzad Siddique
City: Durango RECRUITING
Facility: Mercy Medical Center
Contact Info:
[email protected]
719-776-6550
Shahzad Siddique
City: Durango RECRUITING
Facility: Southwest Oncology PC
Contact Info:
[email protected]
719-776-6550
Shahzad Siddique
City: Lakewood RECRUITING
Facility: Saint Anthony Hospital
Contact Info:
[email protected]
719-776-6550
Shahzad Siddique
City: Littleton RECRUITING
Facility: Littleton Adventist Hospital
Contact Info:
[email protected]
719-776-6550
Shahzad Siddique
City: Longmont RECRUITING
Facility: Longmont United Hospital
Contact Info:
[email protected]
719-776-6550
Shahzad Siddique
City: Parker RECRUITING
Facility: Parker Adventist Hospital
Contact Info:
[email protected]
719-776-6550
Shahzad Siddique
City: Pueblo RECRUITING
Facility: Saint Mary Corwin Medical Center
Contact Info:
[email protected]
719-776-6550
Shahzad Siddique
Connecticut
City: Derby RECRUITING
Facility: Smilow Cancer Hospital-Derby Care Center
Contact Info:
[email protected]
203-785-5702
Joseph W. Kim
City: Fairfield RECRUITING
Facility: Smilow Cancer Hospital Care Center-Fairfield
Contact Info:
[email protected]
203-785-5702
Joseph W. Kim
City: Glastonbury RECRUITING
Facility: Smilow Cancer Hospital Care Center at Glastonbury
Contact Info:
[email protected]
203-785-5702
Joseph W. Kim
City: Greenwich RECRUITING
Facility: Smilow Cancer Hospital Care Center at Greenwich
Contact Info:
[email protected]
203-785-5702
Joseph W. Kim
City: Guilford RECRUITING
Facility: Smilow Cancer Hospital Care Center - Guilford
Contact Info:
[email protected]
203-785-5702
Joseph W. Kim
City: Hartford RECRUITING
Facility: Smilow Cancer Hospital Care Center at Saint Francis
Contact Info:
[email protected]
203-785-5702
Joseph W. Kim
City: New Haven RECRUITING
Facility: Smilow Cancer Center/Yale-New Haven Hospital
Contact Info:
[email protected]
203-785-5702
Joseph W. Kim
City: New Haven RECRUITING
Facility: Yale University
Contact Info:
[email protected]
203-785-5702
Joseph W. Kim
City: North Haven RECRUITING
Facility: Yale-New Haven Hospital North Haven Medical Center
Contact Info:
[email protected]
203-785-5702
Joseph W. Kim
City: Stamford RECRUITING
Facility: Smilow Cancer Hospital Care Center at Long Ridge
Contact Info:
[email protected]
203-785-5702
Joseph W. Kim
City: Torrington RECRUITING
Facility: Smilow Cancer Hospital-Torrington Care Center
Contact Info:
[email protected]
203-785-5702
Joseph W. Kim
City: Trumbull RECRUITING
Facility: Smilow Cancer Hospital Care Center-Trumbull
Contact Info:
[email protected]
203-785-5702
Joseph W. Kim
City: Waterbury RECRUITING
Facility: Smilow Cancer Hospital-Waterbury Care Center
Contact Info:
[email protected]
203-785-5702
Joseph W. Kim
City: Waterford RECRUITING
Facility: Smilow Cancer Hospital Care Center - Waterford
Contact Info:
[email protected]
203-785-5702
Joseph W. Kim
Iowa
City: Council Bluffs RECRUITING
Facility: Alegent Health Mercy Hospital
Contact Info:
[email protected]
402-717-1510
Shahzad Siddique
Idaho
City: Boise RECRUITING
Facility: Saint Alphonsus Cancer Care Center-Boise
Contact Info:
[email protected]
734-712-3671
John M. Schallenkamp
City: Boise RECRUITING
Facility: Saint Luke's Cancer Institute - Boise
Contact Info:
[email protected]
208-381-2774
Charles W. Drescher
City: Caldwell RECRUITING
Facility: Saint Alphonsus Cancer Care Center-Caldwell
Contact Info:
[email protected]
734-712-3671
John M. Schallenkamp
City: Coeur d'Alene RECRUITING
Facility: Kootenai Health - Coeur d'Alene
Contact Info:
[email protected]
406-969-6060
John M. Schallenkamp
City: Emmett RECRUITING
Facility: Walter Knox Memorial Hospital
Contact Info:
[email protected]
734-712-3671
John M. Schallenkamp
City: Fruitland RECRUITING
Facility: Saint Luke's Cancer Institute - Fruitland
Contact Info:
[email protected]
208-381-2774
Charles W. Drescher
City: Meridian RECRUITING
Facility: Idaho Urologic Institute-Meridian
Contact Info:
[email protected]
734-712-3671
John M. Schallenkamp
City: Meridian RECRUITING
Facility: Saint Luke's Cancer Institute - Meridian
Contact Info:
[email protected]
208-381-2774
Charles W. Drescher
City: Nampa RECRUITING
Facility: Saint Luke's Cancer Institute - Nampa
Contact Info:
[email protected]
208-381-2774
Charles W. Drescher
City: Nampa RECRUITING
Facility: Saint Alphonsus Cancer Care Center-Nampa
Contact Info:
[email protected]
406-969-6060
John M. Schallenkamp
City: Post Falls RECRUITING
Facility: Kootenai Clinic Cancer Services - Post Falls
Contact Info:
[email protected]
406-969-6060
John M. Schallenkamp
City: Sandpoint RECRUITING
Facility: Kootenai Cancer Clinic
Contact Info:
[email protected]
406-969-6060
John M. Schallenkamp
City: Twin Falls RECRUITING
Facility: Saint Luke's Cancer Institute - Twin Falls
Contact Info:
[email protected]
208-381-2774
Charles W. Drescher
Illinois
City: Evanston RECRUITING
Facility: NorthShore University HealthSystem-Evanston Hospital
Contact Info:
847-570-2109
Nicklas R. Pfanzelter
City: Glenview RECRUITING
Facility: NorthShore University HealthSystem-Glenbrook Hospital
Contact Info:
847-570-2109
Nicklas R. Pfanzelter
City: Highland Park RECRUITING
Facility: NorthShore University HealthSystem-Highland Park Hospital
Contact Info:
847-570-2109
Nicklas R. Pfanzelter
City: Skokie RECRUITING
Facility: North Shore Medical Center
Contact Info:
[email protected]
888-823-5923
Nicklas R. Pfanzelter
Kentucky
City: Bardstown RECRUITING
Facility: Flaget Memorial Hospital
Contact Info:
[email protected]
859-629-7169
Shahzad Siddique
City: Corbin RECRUITING
Facility: Commonwealth Cancer Center-Corbin
Contact Info:
[email protected]
859-629-7169
Shahzad Siddique
City: Lexington RECRUITING
Facility: Saint Joseph Hospital
Contact Info:
[email protected]
Shahzad Siddique
City: Lexington RECRUITING
Facility: Saint Joseph Radiation Oncology Resource Center
Contact Info:
[email protected]
859-629-7169
Shahzad Siddique
City: Lexington RECRUITING
Facility: Saint Joseph Hospital East
Contact Info:
[email protected]
859-629-7169
Shahzad Siddique
City: London RECRUITING
Facility: Saint Joseph London
Contact Info:
[email protected]
859-629-7169
Shahzad Siddique
City: Mount Sterling RECRUITING
Facility: Saint Joseph Mount Sterling
Contact Info:
[email protected]
Shahzad Siddique
Louisiana
City: Metairie RECRUITING
Facility: LSU Healthcare Network / Metairie Multi-Specialty Clinic
Contact Info:
[email protected]
504-210-3539
Scott E. Delacroix
City: New Orleans RECRUITING
Facility: Louisiana State University Health Science Center
Contact Info:
[email protected]
504-210-3539
Scott E. Delacroix
Montana
City: Anaconda RECRUITING
Facility: Community Hospital of Anaconda
Contact Info:
[email protected]
406-969-6060
John M. Schallenkamp
City: Billings RECRUITING
Facility: Billings Clinic Cancer Center
Contact Info:
[email protected]
800-996-2663
John M. Schallenkamp
City: Bozeman RECRUITING
Facility: Bozeman Deaconess Hospital
Contact Info:
[email protected]
406-969-6060
John M. Schallenkamp
City: Great Falls RECRUITING
Facility: Benefis Healthcare- Sletten Cancer Institute
Contact Info:
[email protected]
406-969-6060
John M. Schallenkamp
City: Great Falls RECRUITING
Facility: Great Falls Clinic
Contact Info:
[email protected]
406-969-6060
John M. Schallenkamp
City: Kalispell RECRUITING
Facility: Kalispell Regional Medical Center
Contact Info:
[email protected]
406-969-6060
John M. Schallenkamp
City: Missoula RECRUITING
Facility: Saint Patrick Hospital - Community Hospital
Contact Info:
[email protected]
406-327-3118
Charles W. Drescher
Nebraska
City: Kearney RECRUITING
Facility: CHI Health Good Samaritan
Contact Info:
[email protected]
308-865-7963
Shahzad Siddique
City: Lincoln RECRUITING
Facility: Saint Elizabeth Regional Medical Center
Contact Info:
[email protected]
855-313-2409
Shahzad Siddique
City: Omaha RECRUITING
Facility: Alegent Health Immanuel Medical Center
Contact Info:
[email protected]
402-717-1510
Shahzad Siddique
City: Omaha RECRUITING
Facility: Alegent Health Bergan Mercy Medical Center
Contact Info:
[email protected]
402-717-1510
Shahzad Siddique
City: Omaha RECRUITING
Facility: Alegent Health Lakeside Hospital
Contact Info:
[email protected]
402-717-1510
Shahzad Siddique
City: Omaha RECRUITING
Facility: Creighton University Medical Center
Contact Info:
[email protected]
402-717-1510
Shahzad Siddique
City: Papillion RECRUITING
Facility: Midlands Community Hospital
Contact Info:
[email protected]
402-717-1510
Shahzad Siddique
New York
City: Middletown RECRUITING
Facility: Garnet Health Medical Center
Contact Info:
[email protected]
845-333-1133
Jeffrey M. Stewart
Ohio
City: Cincinnati RECRUITING
Facility: Good Samaritan Hospital - Cincinnati
Contact Info:
[email protected]
513-853-1300
Shahzad Siddique
City: Cincinnati RECRUITING
Facility: Bethesda North Hospital
Contact Info:
[email protected]
513-853-1300
Shahzad Siddique
City: Cincinnati RECRUITING
Facility: TriHealth Cancer Institute-Westside
Contact Info:
[email protected]
513-853-1300
Shahzad Siddique
City: Cincinnati RECRUITING
Facility: TriHealth Cancer Institute-Anderson
Contact Info:
[email protected]
513-853-1300
Shahzad Siddique
Oklahoma
City: Oklahoma City RECRUITING
Facility: University of Oklahoma Health Sciences Center
Contact Info:
[email protected]
405-271-8777
Kelly L. Stratton
Oregon
City: Baker City RECRUITING
Facility: Saint Alphonsus Medical Center-Baker City
Contact Info:
[email protected]
406-969-6060
John M. Schallenkamp
City: Bend RECRUITING
Facility: Saint Charles Health System
Contact Info:
[email protected]
541-706-2909
Charles W. Drescher
City: Clackamas RECRUITING
Facility: Clackamas Radiation Oncology Center
Contact Info:
[email protected]
503-215-2614
Charles W. Drescher
City: Clackamas RECRUITING
Facility: Providence Cancer Institute Clackamas Clinic
Contact Info:
[email protected]
503-215-2614
Charles W. Drescher
City: Coos Bay RECRUITING
Facility: Bay Area Hospital
Contact Info:
[email protected]
541-269-8392
Charles W. Drescher
City: Newberg RECRUITING
Facility: Providence Newberg Medical Center
Contact Info:
[email protected]
503-215-2614
Charles W. Drescher
City: Ontario RECRUITING
Facility: Saint Alphonsus Medical Center-Ontario
Contact Info:
[email protected]
406-969-6060
John M. Schallenkamp
City: Oregon City RECRUITING
Facility: Providence Willamette Falls Medical Center
Contact Info:
[email protected]
503-215-2614
Charles W. Drescher
City: Portland RECRUITING
Facility: Providence Portland Medical Center
Contact Info:
[email protected]
503-215-2614
Charles W. Drescher
City: Portland RECRUITING
Facility: Providence Saint Vincent Medical Center
Contact Info:
[email protected]
503-215-2614
Charles W. Drescher
City: Portland RECRUITING
Facility: Oregon Health and Science University
Contact Info:
[email protected]
503-494-1080
Alexandra O. Sokolova
City: Redmond RECRUITING
Facility: Saint Charles Health System-Redmond
Contact Info:
541-706-2909
Charles W. Drescher
Rhode Island
City: Westerly RECRUITING
Facility: Smilow Cancer Hospital Care Center - Westerly
Contact Info:
[email protected]
203-785-5702
Joseph W. Kim
Washington
City: Aberdeen RECRUITING
Facility: Providence Regional Cancer System-Aberdeen
Contact Info:
[email protected]
360-412-8958
Charles W. Drescher
City: Bellingham RECRUITING
Facility: PeaceHealth Saint Joseph Medical Center
Contact Info:
360-788-8223
Charles W. Drescher
City: Bremerton RECRUITING
Facility: Harrison Medical Center
Contact Info:
[email protected]
253-426-6882
Shahzad Siddique
City: Centralia RECRUITING
Facility: Providence Regional Cancer System-Centralia
Contact Info:
[email protected]
360-412-8958
Charles W. Drescher
City: Edmonds RECRUITING
Facility: Swedish Cancer Institute-Edmonds
Contact Info:
[email protected]
206-215-3086
Charles W. Drescher
City: Everett RECRUITING
Facility: Providence Regional Cancer Partnership
Contact Info:
[email protected]
425-261-3529
Charles W. Drescher
City: Issaquah RECRUITING
Facility: Swedish Cancer Institute-Issaquah
Contact Info:
[email protected]
206-215-3086
Charles W. Drescher
City: Kennewick RECRUITING
Facility: Kadlec Clinic Hematology and Oncology
Contact Info:
[email protected]
509-783-4637
Charles W. Drescher
City: Lacey RECRUITING
Facility: Providence Regional Cancer System-Lacey
Contact Info:
[email protected]
360-412-8958
Charles W. Drescher
City: Longview RECRUITING
Facility: PeaceHealth Saint John Medical Center
Contact Info:
[email protected]
360-514-2016
Charles W. Drescher
City: Seattle RECRUITING
Facility: Swedish Medical Center-Ballard Campus
Contact Info:
[email protected]
206-215-3086
Charles W. Drescher
City: Seattle RECRUITING
Facility: FHCC South Lake Union
Contact Info:
800-804-8824
Heather H. Cheng
City: Seattle RECRUITING
Facility: Fred Hutchinson Cancer Research Center
Contact Info:
800-804-8824
Heather H. Cheng
City: Seattle RECRUITING
Facility: Swedish Medical Center-Cherry Hill
Contact Info:
[email protected]
206-215-3086
Charles W. Drescher
City: Seattle RECRUITING
Facility: Swedish Medical Center-First Hill
Contact Info:
[email protected]
206-215-3086
Charles W. Drescher
City: Seattle RECRUITING
Facility: University of Washington Medical Center - Montlake
Contact Info:
800-804-8824
Heather H. Cheng
City: Sedro-Woolley RECRUITING
Facility: PeaceHealth United General Medical Center
Contact Info:
[email protected]
360-788-8238
Charles W. Drescher
City: Shelton RECRUITING
Facility: Providence Regional Cancer System-Shelton
Contact Info:
[email protected]
360-412-8958
Charles W. Drescher
City: Vancouver RECRUITING
Facility: PeaceHealth Southwest Medical Center
Contact Info:
[email protected]
360-514-3940
Charles W. Drescher
City: Walla Walla RECRUITING
Facility: Providence Saint Mary Regional Cancer Center
Contact Info:
[email protected]
509-897-5993
Charles W. Drescher
City: Yelm RECRUITING
Facility: Providence Regional Cancer System-Yelm
Contact Info:
[email protected]
360-412-8958
Charles W. Drescher
Wyoming
City: Cody RECRUITING
Facility: Billings Clinic-Cody
Contact Info:
[email protected]
800-996-2663
John M. Schallenkamp
City: Sheridan RECRUITING
Facility: Welch Cancer Center
Contact Info:
[email protected]
406-969-6060
John M. Schallenkamp
This study is open to people assigned male at birth who:
- have a diagnosis of cancer.
- have a high or very high-risk cancer defined by AT LEAST ONE of the following prior to registration:
- a minimum 3b cancer, meaning the cancer extends beyond the prostate;
- Gleason Grade Group 4 or 5 (also known as Gleason sum 8-10); OR
- Specific Antigen, , is a blood test ordered by your doctor
- have an inherited or mutation.
- had surgery or radiation for cancer before registration.
This study is not open to people who:
- will be treated for cancer more thanone month into participating in this study.
- have been treated with radiation to the pelvic area.
- has cancer that is found through imaging less than 90 days before registration.
- people who have a tumor that can be removed by surgery can reach out to the study team to confirm if you are still eligible.
- do not have evidence of distant disease by conventional imaging within 90 days prior to registration.
- have initiated gonadotrophin releasing hormone (gnRH) agonist, gnRH antagonist, oral anti-androgen (e.g. bicalutamide, nilutamide, flutamide), or other drug intended to treat 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.
- are can undergo surgery and receive carboplatin.