Phase
Condition
Prostate Cancer
Adenocarcinoma
Prostate Disorders
Treatment
Carboplatin
Surgical Procedure
Chest Radiography
Clinical Study ID
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant must have histologic diagnosis of prostate adenocarcinoma
Participant must have high or very high-risk disease defined by at least one of thefollowing:
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/likelypathogenic variant) in BRCA2 or BRCA1 through testing in a Clinical LaboratoryImprovement Act (CLIA)-certified lab
NOTE: Local lab report is sufficient for eligibility
Participant may have initiated gonadotrophin releasing hormone (gnRH) agonist, gnRHantagonist, oral anti-androgen (e.g. bicalutamide, nilutamide, flutamide), or otheragent intended to treat prostate cancer prior to registration. The effectiveness ofthe current depot of such treatment must not extend beyond 1 month after studyregistration. 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 daysprior 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 institutionalupper 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 thefollowing Cockcroft-Gault Formula. This specimen must have been drawn and processedwithin 28 days prior to registration
Participant must have adequate cardiac function. Participants with known history orcurrent symptoms of cardiac disease, or history of treatment with cardiotoxicagents, must have a clinical risk assessment of cardiac function using the New YorkHeart Association Functional Classification within 28 days prior to registration. Tobe eligible for this trial, participants must be class 2B or better
Participant with known human immunodeficiency virus (HIV)-infection must bereceiving anti-retroviral therapy and have an undetectable viral load test within 6months prior to registration
Participant with history of chronic hepatitis B virus (HBV) infection must haveundetectable HBV viral load on suppressive therapy within in 28 days prior toregistration
Participant with a history of hepatitis C virus (HCV) infection must have beentreated and cured. For participants with HCV infection who are currently ontreatment must have an undetectable HCV viral load within in 28 days prior toregistration
Participants who are of reproductive potential must have agreed to use an effectivecontraceptive method with details provided as a part of the consent process. Aperson who has semen likely to contain sperm is considered to be of "reproductivepotential." In addition to routine contraceptive methods, "effective contraception"also includes refraining from sexual activity that might result in pregnancy andsurgery intended to prevent pregnancy (or with a side-effect of pregnancyprevention) including vasectomy with testing showing no sperm in the semen
Prior to registration, participant must have had a urologic consult and be deemed asurgical candidate with known sites of disease deemed by the urologist to bepotentially resectable
Participants must be offered the opportunity to participate in specimen banking.With participant consent, specimens must be collected and submitted via theSouthwest Oncology Group (SWOG) Specimen Tracking System
NOTE: As a part of the OPEN registration process the treating institution's identityis provided in order to ensure that the current (within 365 days) date ofinstitutional review board approval for this study has been entered in the system
Participants must be informed of the investigational nature of this study andmust sign and give informed consent in accordance with institutional andfederal guidelines
For participants with impaired decision-making capabilities, legally authorizedrepresentatives may sign and give informed consent on behalf of studyparticipants in accordance with applicable federal, local, and CentralInstitutional Review Board (CIRB) regulations
As part of the registration process the treating institution's identity isprovided in order to ensure that the current (within 365 days) date ofinstitutional review board approval for this study has been entered in thesystem
Exclusion
Exclusion Criteria:
Participant must not have evidence of distant metastatic disease by conventionalimaging within 90 days prior to registration
NOTE: cN1 detected only by PSMA-PET is permitted if urologist deems sites ofdisease to be potentially completely resectable
Participant must not have received prior radiation therapy (RT) to the pelvic region
Participant must not have a prior or concurrent malignancy whose natural history ortreatment (in the opinion of the treating physician) has the potential to interferewith the safety or efficacy assessment of protocol treatment
Study Design
Study Description
Connect with a study center
Alaska Breast Care and Surgery LLC
Anchorage, Alaska 99508
United StatesActive - Recruiting
Alaska Oncology and Hematology LLC
Anchorage, Alaska 99508
United StatesActive - Recruiting
Alaska Women's Cancer Care
Anchorage, Alaska 99508
United StatesActive - Recruiting
Anchorage Associates in Radiation Medicine
Anchorage, Alaska 98508
United StatesActive - Recruiting
Anchorage Oncology Centre
Anchorage, Alaska 99508
United StatesActive - Recruiting
Anchorage Radiation Therapy Center
Anchorage, Alaska 99504
United StatesActive - Recruiting
Katmai Oncology Group
Anchorage, Alaska 99508
United StatesActive - Recruiting
Providence Alaska Medical Center
Anchorage, Alaska 99508
United StatesActive - Recruiting
Cancer Center at Saint Joseph's
Phoenix, Arizona 85004
United StatesActive - Recruiting
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California 93420
United StatesActive - Recruiting
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California 91505
United StatesActive - Recruiting
Mercy Cancer Center �� Carmichael
Carmichael, California 95608
United StatesActive - Recruiting
Mercy San Juan Medical Center
Carmichael, California 95608
United StatesActive - Recruiting
City of Hope Comprehensive Cancer Center
Duarte, California 91010
United StatesActive - Recruiting
Mercy Cancer Center - Elk Grove
Elk Grove, California 95758
United StatesActive - Recruiting
City of Hope at Irvine Lennar
Irvine, California 92618
United StatesActive - Recruiting
Providence Queen of The Valley
Napa, California 94558
United StatesActive - Recruiting
Mercy Cancer Center - Rocklin
Rocklin, California 95765
United StatesActive - Recruiting
Mercy Cancer Center - Sacramento
Sacramento, California 95816
United StatesActive - Recruiting
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California 93401
United StatesActive - Recruiting
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California 93444
United StatesActive - Recruiting
Providence Medical Foundation - Santa Rosa
Santa Rosa, California 95403
United StatesActive - Recruiting
Providence Santa Rosa Memorial Hospital
Santa Rosa, California 95405
United StatesActive - Recruiting
Woodland Memorial Hospital
Woodland, California 95695
United StatesActive - Recruiting
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado 80907
United StatesActive - Recruiting
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado 80907
United StatesActive - Recruiting
Saint Francis Cancer Center
Colorado Springs, Colorado 80923
United StatesActive - Recruiting
Porter Adventist Hospital
Denver, Colorado 80210
United StatesActive - Recruiting
Mercy Medical Center
Durango, Colorado 81301
United StatesActive - Recruiting
Southwest Oncology PC
Durango, Colorado 81301
United StatesActive - Recruiting
Saint Anthony Hospital
Lakewood, Colorado 80228
United StatesActive - Recruiting
Littleton Adventist Hospital
Littleton, Colorado 80122
United StatesActive - Recruiting
Longmont United Hospital
Longmont, Colorado 80501
United StatesActive - Recruiting
Parker Adventist Hospital
Parker, Colorado 80138
United StatesActive - Recruiting
Saint Mary Corwin Medical Center
Pueblo, Colorado 81004
United StatesActive - Recruiting
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut 06418
United StatesActive - Recruiting
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut 06824
United StatesActive - Recruiting
Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut 06033
United StatesActive - Recruiting
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut 06830
United StatesActive - Recruiting
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut 06437
United StatesActive - Recruiting
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut 06105
United StatesActive - Recruiting
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut 06510
United StatesActive - Recruiting
Yale University
New Haven, Connecticut 06520
United StatesActive - Recruiting
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut 06473
United StatesActive - Recruiting
Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut 06902
United StatesActive - Recruiting
Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut 06790
United StatesActive - Recruiting
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut 06611
United StatesActive - Recruiting
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut 06708
United StatesActive - Recruiting
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut 06385
United StatesActive - Recruiting
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho 83706
United StatesActive - Recruiting
Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712
United StatesActive - Recruiting
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho 83605
United StatesActive - Recruiting
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho 83814
United StatesActive - Recruiting
Walter Knox Memorial Hospital
Emmett, Idaho 83617
United StatesActive - Recruiting
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho 83619
United StatesActive - Recruiting
Idaho Urologic Institute-Meridian
Meridian, Idaho 83642
United StatesActive - Recruiting
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho 83642
United StatesActive - Recruiting
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho 83687
United StatesActive - Recruiting
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho 83686
United StatesActive - Recruiting
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854
United StatesActive - Recruiting
Kootenai Cancer Clinic
Sandpoint, Idaho 83864
United StatesActive - Recruiting
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho 83301
United StatesActive - Recruiting
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois 60201
United StatesActive - Recruiting
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois 60026
United StatesActive - Recruiting
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois 60035
United StatesActive - Recruiting
North Shore Medical Center
Skokie, Illinois 60076
United StatesActive - Recruiting
Alegent Health Mercy Hospital
Council Bluffs, Iowa 51503
United StatesActive - Recruiting
Flaget Memorial Hospital
Bardstown, Kentucky 40004
United StatesActive - Recruiting
Commonwealth Cancer Center-Corbin
Corbin, Kentucky 40701
United StatesActive - Recruiting
Saint Joseph Hospital
Lexington, Kentucky 40504
United StatesActive - Recruiting
Saint Joseph Hospital East
Lexington, Kentucky 40509
United StatesActive - Recruiting
Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky 40504
United StatesActive - Recruiting
Saint Joseph London
London, Kentucky 40741
United StatesActive - Recruiting
Saint Joseph Mount Sterling
Mount Sterling, Kentucky 40353
United StatesActive - Recruiting
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie, Louisiana 70006
United StatesActive - Recruiting
Louisiana State University Health Science Center
New Orleans, Louisiana 70112
United StatesActive - Recruiting
Community Hospital of Anaconda
Anaconda, Montana 59711
United StatesActive - Recruiting
Billings Clinic Cancer Center
Billings, Montana 59101
United StatesActive - Recruiting
Bozeman Deaconess Hospital
Bozeman, Montana 59715
United StatesActive - Recruiting
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana 59405
United StatesActive - Recruiting
Great Falls Clinic
Great Falls, Montana 59405
United StatesActive - Recruiting
Kalispell Regional Medical Center
Kalispell, Montana 59901
United StatesActive - Recruiting
Community Medical Hospital
Missoula, Montana 59804
United StatesSuspended
Saint Patrick Hospital - Community Hospital
Missoula, Montana 59802
United StatesActive - Recruiting
CHI Health Good Samaritan
Kearney, Nebraska 68847
United StatesActive - Recruiting
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska 68510
United StatesActive - Recruiting
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska 68124
United StatesActive - Recruiting
Alegent Health Immanuel Medical Center
Omaha, Nebraska 68122
United StatesActive - Recruiting
Alegent Health Lakeside Hospital
Omaha, Nebraska 68130
United StatesActive - Recruiting
Creighton University Medical Center
Omaha, Nebraska 68131
United StatesActive - Recruiting
Midlands Community Hospital
Papillion, Nebraska 68046
United StatesActive - Recruiting
Garnet Health Medical Center
Middletown, New York 10940
United StatesActive - Recruiting
Bethesda North Hospital
Cincinnati, Ohio 45242
United StatesActive - Recruiting
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio 45220
United StatesActive - Recruiting
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio 45255
United StatesActive - Recruiting
TriHealth Cancer Institute-Westside
Cincinnati, Ohio 45247
United StatesActive - Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United StatesActive - Recruiting
Saint Alphonsus Medical Center-Baker City
Baker City, Oregon 97814
United StatesActive - Recruiting
Saint Charles Health System
Bend, Oregon 97701
United StatesActive - Recruiting
Clackamas Radiation Oncology Center
Clackamas, Oregon 97015
United StatesActive - Recruiting
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon 97015
United StatesActive - Recruiting
Bay Area Hospital
Coos Bay, Oregon 97420
United StatesActive - Recruiting
Providence Newberg Medical Center
Newberg, Oregon 97132
United StatesActive - Recruiting
Saint Alphonsus Medical Center-Ontario
Ontario, Oregon 97914
United StatesActive - Recruiting
Providence Willamette Falls Medical Center
Oregon City, Oregon 97045
United StatesActive - Recruiting
Oregon Health and Science University
Portland, Oregon 97239
United StatesActive - Recruiting
Providence Portland Medical Center
Portland, Oregon 97213
United StatesActive - Recruiting
Providence Saint Vincent Medical Center
Portland, Oregon 97225
United StatesActive - Recruiting
Saint Charles Health System-Redmond
Redmond, Oregon 97756
United StatesActive - Recruiting
Smilow Cancer Hospital Care Center - Westerly
Westerly, Rhode Island 02891
United StatesActive - Recruiting
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington 98520
United StatesActive - Recruiting
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington 98225
United StatesActive - Recruiting
Harrison Medical Center
Bremerton, Washington 98310
United StatesActive - Recruiting
Providence Regional Cancer System-Centralia
Centralia, Washington 98531
United StatesActive - Recruiting
Swedish Cancer Institute-Edmonds
Edmonds, Washington 98026
United StatesActive - Recruiting
Providence Regional Cancer Partnership
Everett, Washington 98201
United StatesActive - Recruiting
Swedish Cancer Institute-Issaquah
Issaquah, Washington 98029
United StatesActive - Recruiting
Kadlec Clinic Hematology and Oncology
Kennewick, Washington 99336
United StatesActive - Recruiting
Providence Regional Cancer System-Lacey
Lacey, Washington 98503
United StatesActive - Recruiting
PeaceHealth Saint John Medical Center
Longview, Washington 98632
United StatesActive - Recruiting
FHCC South Lake Union
Seattle, Washington 98109
United StatesActive - Recruiting
Fred Hutchinson Cancer Research Center
Seattle, Washington 98109
United StatesActive - Recruiting
Swedish Medical Center-Ballard Campus
Seattle, Washington 98107
United StatesActive - Recruiting
Swedish Medical Center-Cherry Hill
Seattle, Washington 98122-5711
United StatesActive - Recruiting
Swedish Medical Center-First Hill
Seattle, Washington 98122
United StatesActive - Recruiting
University of Washington Medical Center - Montlake
Seattle, Washington 98195
United StatesActive - Recruiting
PeaceHealth United General Medical Center
Sedro-Woolley, Washington 98284
United StatesActive - Recruiting
Providence Regional Cancer System-Shelton
Shelton, Washington 98584
United StatesActive - Recruiting
PeaceHealth Southwest Medical Center
Vancouver, Washington 98664
United StatesActive - Recruiting
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington 99362
United StatesActive - Recruiting
Providence Regional Cancer System-Yelm
Yelm, Washington 98597
United StatesActive - Recruiting
Billings Clinic-Cody
Cody, Wyoming 82414
United StatesActive - Recruiting
Welch Cancer Center
Sheridan, Wyoming 82801
United StatesActive - Recruiting
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