Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery
Stage I Prostate Adenocarcinoma, Stage II Prostate Adenocarcinoma, Stage III Prostate Adenocarcinoma
About this trial
This is an interventional treatment trial for Stage I Prostate Adenocarcinoma
Eligibility Criteria
Inclusion Criteria:
- Patients post-prostatectomy with baseline Gleason >= 7 (per prostatectomy pathology) and baseline PSA prior to the start of androgen deprivation therapy nadir >= 0.2 ng/ml (post-operative value is never undetectable) obtained prior to step 1 registration
- Baseline testosterone level obtained post prostatectomy prior to the start of androgen deprivation therapy and prior to step 1 registration
- Pathologically (histologically) proven diagnosis of adenocarcinoma of the prostate as confirmed at time of prostatectomy; prostatectomy must have been performed =< 365 days (1 year) prior to step 1 registration
- Primary treatment with radical prostatectomy
- Any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted
- Prior ablative treatment for treatment of benign prostatic hypertrophy or focal high-intensity focused ultrasound therapy (HIFU) prior to prostatectomy is allowed
- Prior androgen deprivation (luteinizing hormone-releasing hormone [LHRH] agonist and/or non-steroidal anti-androgen) is allowed if discontinued at least 90 days prior to study enrollment and given for =< 90 days duration prior to radical prostatectomy; finasteride or dutasteride must be stopped before treatment but should not determine eligibility; for patients on prior LHRH analogs, the discontinuation date should be calculated based the expected duration of the sustained release injection, not simply the injection date of the drug
- Pathologically proven to be lymph node negative by pelvic lymphadenectomy (pN0) or lymph node status pathologically unknown (undissected pelvic lymph nodes [pNx])
Any pT-stage based on American Joint Committee on Cancer 7th edition is acceptable for study entry based on the following diagnostic workup:
- History/physical examination within 60 days prior to step 1 registration
- No distant metastases, based upon the following minimum diagnostic workup:
- A computed tomography (CT) scan of the abdomen and/or pelvis (with contrast if renal function is acceptable; a CT without contrast is permitted if the patient is not a candidate for contrast) or magnetic resonance imaging (MRI) of the pelvis within 120 days prior to step 1 registration; lymph nodes will be non-metastatic unless they measure more than 1.5 cm short axis;
- Bone scan within 120 days prior to step 1 registration (a sodium fluoride [NaF] positron emission tomography/computed tomography [PET/CT] is an acceptable substitute); if the bone scan is suspicious, a plain x-ray, CT scan, NaF PET/CT and/or MRI must be obtained to rule out metastasis
- Eastern Cooperative Oncology Group (ECOG) performance status of =< 1 within 90 days prior to step 1 registration
- Platelets >= 1 X 10^6 cells/mm^3 (100,000) based upon complete blood count (CBC)
- Hemoglobin >= 10.0 g/dl based upon CBC (Note: The use of transfusion or other intervention to achieve Hgb >= 10.0 g/dl is not allowed)
- Absolute neutrophil count greater than 1.5 x 10^9/L (1500)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 1.5 x the upper limit of normal
- Total bilirubin normal unless history of Gilbert's syndrome
- The patient or a legally authorized representative must provide study-specific informed consent prior to step 1 registration
- Available surgical formalin-fixed paraffin-embedded (FFPE) specimen for genomic analysis on DECIPHER Genomic Resource Information Database (GRID) platform
Exclusion Criteria:
- Definitive clinical or radiologic evidence of metastatic disease
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years) Ta bladder cancer is not considered invasive
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable if completed more than two years prior to step 1 registration; prior androgen deprivation is allowed
- Prior whole gland ablative therapy (i.e. cryoablation or high intensity focused ultrasound [HIFU]) for prostate cancer is allowed; prior focal HIFU or treatment for benign prostatic hypertrophy is allowed
- Prostatectomy performed greater than 365 days (1 year) prior to step 1 registration
Severe and/or active co-morbidity defined as follows:
- History of inflammatory bowel disease
- History of active hepatitis B or C; blood tests are not required to determine if the patient has had hepatitis B or C, unless the patient reports a history of hepatitis
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 1 registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization within 15 days of step 1 registration or precluding study therapy at the time of step 1 registration
- Uncontrolled severe illness or medical condition (including uncontrolled diabetes), which in the judgment of the treating physician would make the administration of chemotherapy inadvisable
- Concurrent or planned treatment with strong inhibitors (e.g. ketoconazole, clarithromycin, etcetera [etc]) or strong inducers (e.g. carbamazepine, phenytoin, rifampin, phenobarbital, efavirenz, tipranavir, St. John's wort) of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments)
- Human immunodeficiency virus (HIV) positive with cluster of differentiation 4 (CD4) count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to step 1 registration; note also that HIV testing is not required for eligibility for this protocol
Sites / Locations
- Mobile Infirmary Medical Center
- Fairbanks Memorial Hospital
- Cancer Center at Saint Joseph's
- University of Arizona Cancer Center-Orange Grove Campus
- Banner University Medical Center - Tucson
- University of Arizona Cancer Center-North Campus
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
- Kaiser Permanente-Deer Valley Medical Center
- Adventist Health Cancer Care Center Chico
- Kaiser Permanente Dublin
- Kaiser Permanente-Fremont
- Fresno Cancer Center
- Kaiser Permanente-Fresno
- UC San Diego Moores Cancer Center
- Kaiser Permanente-Modesto
- Kaiser Permanente Oakland-Broadway
- Kaiser Permanente-Oakland
- Kaiser Permanente-Rancho Cordova Cancer Center
- Kaiser Permanente-Redwood City
- Kaiser Permanente-Richmond
- Rohnert Park Cancer Center
- Kaiser Permanente-Roseville
- Sutter Cancer Centers Radiation Oncology Services-Roseville
- The Permanente Medical Group-Roseville Radiation Oncology
- Sutter Medical Center Sacramento
- Kaiser Permanente-South Sacramento
- South Sacramento Cancer Center
- Kaiser Permanente - Sacramento
- Naval Medical Center -San Diego
- Kaiser Permanente-San Francisco
- Kaiser Permanente-Santa Teresa-San Jose
- Kaiser Permanente San Leandro
- Kaiser Permanente-San Rafael
- Kaiser San Rafael-Gallinas
- Kaiser Permanente Medical Center - Santa Clara
- Kaiser Permanente-Santa Rosa
- Kaiser Permanente Cancer Treatment Center
- Kaiser Permanente-South San Francisco
- Kaiser Permanente-Stockton
- Palo Alto Medical Foundation-Sunnyvale
- Gene Upshaw Memorial Tahoe Forest Cancer Center
- Kaiser Permanente Medical Center-Vacaville
- Kaiser Permanente-Vallejo
- Sutter Solano Medical Center/Cancer Center
- Kaiser Permanente-Walnut Creek
- University of Colorado Hospital
- Penrose-Saint Francis Healthcare
- UCHealth Memorial Hospital Central
- Poudre Valley Hospital
- Beebe South Coastal Health Campus
- Helen F Graham Cancer Center
- Christiana Care Health System-Christiana Hospital
- Beebe Health Campus
- GenesisCare USA - Aventura FP
- GenesisCare USA - Aventura
- Mount Sinai Comprehensive Cancer Center at Aventura
- AdventHealth Celebration
- UM Sylvester Comprehensive Cancer Center at Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach
- GenesisCare USA - Key West
- AdventHealth Kissimmee
- Lakeland Regional Health Hollis Cancer Center
- GenesisCare USA - Lakewood Ranch
- Mount Sinai Medical Center
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- AdventHealth Orlando
- GenesisCare USA - Plantation
- Grady Health System
- Emory University Hospital Midtown
- Piedmont Hospital
- Emory University Hospital/Winship Cancer Institute
- Emory Saint Joseph's Hospital
- Piedmont Fayette Hospital
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Saint Alphonsus Cancer Care Center-Boise
- Alton Memorial Hospital
- Illinois CancerCare-Bloomington
- Illinois CancerCare-Canton
- Illinois CancerCare-Carthage
- Northwestern University
- Rush University Medical Center
- Decatur Memorial Hospital
- Crossroads Cancer Center
- Elmhurst Memorial Hospital
- Illinois CancerCare-Eureka
- Illinois CancerCare-Galesburg
- Ingalls Memorial Hospital
- Illinois CancerCare-Kewanee Clinic
- Illinois CancerCare-Macomb
- Loyola University Medical Center
- Edward Hospital/Cancer Center
- Illinois CancerCare-Ottawa Clinic
- Illinois CancerCare-Pekin
- Illinois CancerCare-Peoria
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
- Methodist Medical Center of Illinois
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Edward Hospital/Cancer Center?Plainfield
- Illinois CancerCare-Princeton
- Parkview Hospital Randallia
- Parkview Regional Medical Center
- Goshen Center for Cancer Care
- Indiana University/Melvin and Bren Simon Cancer Center
- Reid Health
- McFarland Clinic PC - Ames
- Mercy Hospital
- University of Kansas Cancer Center
- Olathe Health Cancer Center
- University of Kansas Cancer Center-Overland Park
- Cotton O'Neil Cancer Center / Stormont Vail Health
- Ascension Via Christi Hospitals Wichita
- East Jefferson General Hospital
- LSU Healthcare Network / Metairie Multi-Specialty Clinic
- Ochsner Medical Center Jefferson
- University of Maryland/Greenebaum Cancer Center
- Central Maryland Radiation Oncology in Howard County
- UM Baltimore Washington Medical Center/Tate Cancer Center
- TidalHealth Richard A Henson Cancer Institute
- TidalHealth Peninsula Regional
- Boston Medical Center
- Lahey Hospital and Medical Center
- Lahey Medical Center-Peabody
- Winchester Hospital
- Saint Joseph Mercy Hospital
- University of Michigan Comprehensive Cancer Center
- Henry Ford Cancer Institute-Downriver
- GenesisCare USA - Clarkston
- McLaren Cancer Institute-Clarkston
- Henry Ford Macomb Hospital-Clinton Township
- Beaumont Hospital - Dearborn
- Wayne State University/Karmanos Cancer Institute
- Henry Ford Hospital
- Ascension Saint John Hospital
- GenesisCare USA - Farmington Hills
- Weisberg Cancer Treatment Center
- McLaren Cancer Institute-Flint
- Spectrum Health at Butterworth Campus
- Allegiance Health
- West Michigan Cancer Center
- Karmanos Cancer Institute at McLaren Greater Lansing
- Mid-Michigan Physicians-Lansing
- Sparrow Hospital
- McLaren Cancer Institute-Lapeer Region
- Trinity Health Saint Mary Mercy Livonia Hospital
- GenesisCare USA - Macomb
- GenesisCare USA - Madison Heights
- McLaren Cancer Institute-Macomb
- McLaren Cancer Institute-Central Michigan
- McLaren Cancer Institute-Northern Michigan
- 21st Century Oncology-Pontiac
- Saint Joseph Mercy Oakland
- McLaren-Port Huron
- William Beaumont Hospital-Royal Oak
- Ascension Saint Mary's Hospital
- William Beaumont Hospital - Troy
- GenesisCare USA - Troy
- Saint John Macomb-Oakland Hospital
- Henry Ford West Bloomfield Hospital
- Metro Health Hospital
- Mayo Clinic Health System in Albert Lea
- Sanford Joe Lueken Cancer Center
- Saint Luke's Hospital of Duluth
- Fairview Southdale Hospital
- Mayo Clinic Health Systems-Mankato
- Hennepin County Medical Center
- Mayo Clinic in Rochester
- Coborn Cancer Center at Saint Cloud Hospital
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- University of Mississippi Medical Center
- Saint Francis Medical Center
- The University of Kansas Cancer Center-South
- University of Kansas Cancer Center - North
- University of Kansas Cancer Center - Lee's Summit
- Delbert Day Cancer Institute at PCRMC
- Heartland Regional Medical Center
- Washington University School of Medicine
- Siteman Cancer Center-South County
- Siteman Cancer Center at Christian Hospital
- Mercy Hospital Saint Louis
- Siteman Cancer Center at Saint Peters Hospital
- Mercy Hospital Springfield
- Billings Clinic Cancer Center
- Bozeman Deaconess Hospital
- Benefis Healthcare- Sletten Cancer Institute
- Kalispell Regional Medical Center
- Nebraska Methodist Hospital
- Radiation Oncology Centers of Nevada Central
- Radiation Oncology Centers of Nevada Southeast
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
- AtlantiCare Health Park-Cape May Court House
- AtlantiCare Surgery Center
- Robert Wood Johnson University Hospital Somerset
- New York-Presbyterian/Brooklyn Methodist Hospital
- Roswell Park Cancer Institute
- Highland Hospital
- University of Rochester
- Stony Brook University Medical Center
- Dickstein Cancer Treatment Center
- Duke University Medical Center
- Cone Health Cancer Center
- Margaret R Pardee Memorial Hospital
- Wake Forest University Health Sciences
- Sanford Bismarck Medical Center
- Sanford Roger Maris Cancer Center
- UHHS-Chagrin Highlands Medical Center
- Geauga Hospital
- Case Western Reserve University
- Ohio State University Comprehensive Cancer Center
- Miami Valley Hospital North
- Mercy Cancer Center-Elyria
- Atrium Medical Center-Middletown Regional Hospital
- UH Seidman Cancer Center at Lake Health Mentor Campus
- UH Seidman Cancer Center at Southwest General Hospital
- University Hospitals Parma Medical Center
- University Hospitals Portage Medical Center
- UH Seidman Cancer Center at Firelands Regional Medical Center
- Springfield Regional Cancer Center
- ProMedica Flower Hospital
- University of Toledo
- UHHS-Westlake Medical Center
- Cancer Centers of Southwest Oklahoma Research
- University of Oklahoma Health Sciences Center
- Clackamas Radiation Oncology Center
- Providence Portland Medical Center
- Providence Saint Vincent Medical Center
- Jefferson Abington Hospital
- Crozer-Keystone Regional Cancer Center at Broomall
- Christiana Care Health System-Concord Health Center
- Geisinger Medical Center
- Northeast Radiation Oncology Center
- Saint Vincent Hospital
- Crozer Regional Cancer Center at Brinton Lake
- UPMC Pinnacle Cancer Center/Community Osteopathic Campus
- Jefferson Hospital
- Saint Mary Medical and Regional Cancer Center
- Geisinger Medical Oncology-Lewisburg
- Lewistown Hospital
- Forbes Hospital
- Thomas Jefferson University Hospital
- Fox Chase Cancer Center
- Jefferson Torresdale Hospital
- Temple University Hospital
- Allegheny General Hospital
- Penn State Health Saint Joseph Medical Center
- Reading Hospital
- Wexford Health and Wellness Pavilion
- Geisinger Wyoming Valley/Henry Cancer Center
- Asplundh Cancer Pavilion
- Prisma Health Cancer Institute - Spartanburg
- Medical University of South Carolina
- Prisma Health Cancer Institute - Faris
- Saint Francis Cancer Center
- Prisma Health Cancer Institute - Eastside
- Self Regional Healthcare
- Prisma Health Cancer Institute - Greer
- Gibbs Cancer Center-Pelham
- The Radiation Oncology Center-Hilton Head/Bluffton
- Carolina Regional Cancer Center
- Prisma Health Cancer Institute - Seneca
- Spartanburg Medical Center
- Avera Cancer Institute
- Sanford USD Medical Center - Sioux Falls
- UT Southwestern/Simmons Cancer Center-Dallas
- University of Texas Medical Branch
- UTMB Cancer Center at Victory Lakes
- Sandra L Maxwell Cancer Center
- Logan Regional Hospital
- Intermountain Medical Center
- McKay-Dee Hospital Center
- Saint George Regional Medical Center
- Utah Cancer Specialists-Salt Lake City
- LDS Hospital
- Southwestern Vermont Medical Center
- Norris Cotton Cancer Center-North
- University of Virginia Cancer Center
- MultiCare Auburn Medical Center
- West Virginia University Charleston Division
- West Virginia University Healthcare
- Camden Clark Medical Center
- Langlade Hospital and Cancer Center
- ThedaCare Regional Cancer Center
- Marshfield Medical Center-EC Cancer Center
- Aurora Cancer Care-Grafton
- Aurora BayCare Medical Center
- UW Cancer Center Johnson Creek
- Aurora Cancer Care-Kenosha South
- Aurora Bay Area Medical Group-Marinette
- Marshfield Medical Center-Marshfield
- Froedtert Menomonee Falls Hospital
- Ascension Columbia Saint Mary's Hospital Ozaukee
- Ascension Columbia Saint Mary's Hospital - Milwaukee
- Aurora Saint Luke's Medical Center
- Medical College of Wisconsin
- Aurora Sinai Medical Center
- Zablocki Veterans Administration Medical Center
- Marshfield Clinic-Minocqua Center
- Drexel Town Square Health Center
- Vince Lombardi Cancer Clinic - Oshkosh
- Marshfield Medical Center-Rice Lake
- Vince Lombardi Cancer Clinic-Sheboygan
- Marshfield Medical Center-River Region at Stevens Point
- Aurora Medical Center in Summit
- Vince Lombardi Cancer Clinic-Two Rivers
- Aspirus Regional Cancer Center
- Aurora Cancer Care-Milwaukee West
- Aurora West Allis Medical Center
- Froedtert West Bend Hospital/Kraemer Cancer Center
- Diagnostic and Treatment Center
- Marshfield Medical Center - Weston
- Aspirus Cancer Care - Wisconsin Rapids
- Tom Baker Cancer Centre
- Centro Comprensivo de Cancer de UPR
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm I (androgen deprivation therapy, EBRT)
Arm II (androgen deprivation therapy, EBRT, docetaxel)
Patients receive androgen deprivation therapy comprising leuprolide acetate, goserelin acetate, bicalutamide, flutamide, or nilutamide for 6 months. Beginning 8 weeks after the start of androgen deprivation therapy, patients receive EBRT for 7.5 weeks.
Patients receive androgen deprivation therapy and EBRT as in Arm I. Within 4-6 weeks after completion of radiation therapy, patients receive docetaxel IV on day 1 of every 21 days for 6 courses in the absence of disease progression or unexpected toxicity.