A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery
NCT ID: NCT03809000
Last Updated: 2025-12-30
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
188 participants
INTERVENTIONAL
2019-04-15
2029-09-15
Brief Summary
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Detailed Description
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To determine whether, in men with post-prostatectomy PSA (prostate specific antigen) recurrences with aggressive disease features, salvage radiotherapy (SRT) with enhanced androgen deprivation therapy (ADT), consisting of enzalutamide (MDV3100) and a GnRH analog, will improve progression-free survival compared to SRT with standard GnRH analog -based ADT.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Salvage Radiation Therapy (SRT) + Standard androgen deprivation therapy (ADT)
Standard ADT: 24 months of GnRH analog (any formulation) with optional 1-4 months of bicalutamide (50 mg/day).
SRT: Starting within 0-70 days of initiation of GnRH analog, 66.6-70.2 Gy as 1.8 Gy/fraction in 37-39 fractions or 66.0-70.0 Gy as 2.0 Gy/fraction in 33-35 fractions lasting approximately 7-8 weeks, and optional lymph node boost.
Radiation Therapy
daily fractions
Bicalutamide
tablet
GnRH analog
Injection
Salvage Radiation Therapy + Enhanced ADT
Enhanced ADT: 24 months of GnRH analog (any formulation) with 24 months of enzalutamide (160 mg/day).
SRT: Starting within 0-70 days of initiation of GnRH analog, 66.6-70.2 Gy as 1.8 Gy/fraction in 37-39 fractions or 66.0-70.0 Gy as 2.0 Gy/fraction in 33-35 fractions lasting approximately 7-8 weeks, and optional lymph node boost.
Radiation Therapy
daily fractions
Enzalutamide
tablet
GnRH analog
Injection
Interventions
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Radiation Therapy
daily fractions
Enzalutamide
tablet
Bicalutamide
tablet
GnRH analog
Injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prostate-specific antigen (PSA) level (≥ 0.2 ng/mL) within 120 days prior to registration. Patients must have a PSA ≥ 0.2 ng/mL prior to starting ADT. For patients being followed by an ultrasensitive PSA assay, a serum PSA concentration of ≥ 0.10 ng/mL will be considered eligible.
* GnRH analog may be started no more than 42 days prior study entry.
* Hemoglobin ≥ 9.0 g/dL, independent of transfusion and/or growth factors within 90 days prior to registration.
* Platelet count ≥ 75,000 x 10\^9/µL independent of transfusion and/or growth factors within 90 days prior to registration.
* At least 1 of the following aggressive features:
* Gleason score of 8-10 (note any Gleason score is eligible)
* Seminal vesicle invasion (SVI) (note any pT stage American Joint Committee on Cancer (AJCC) v8.0 is eligible but a pT stage
≥ pT3b is considered aggressive)
* Locoregional node involvement at radical prostatectomy (RP) (pN1)
* Persistently elevated PSA post-RP nadir (PEPP) defined as PSA \> 0.1 ng/mL after radical prostatectomy
* PSA ≥ 0.7 ng/mL
* Serum albumin ≥ 3.0 g/dL within 90 days prior to registration
* Glomerular filtration rate (GFR) ≥35 mL/min estimated by Cockcroft-Gault or measured directly by 24 hour urine creatinine within 90 days prior to registration.
* Serum total bilirubin ≤1.5 × upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is \>1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, subject is eligible) within 90 days prior to registration.
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \<2.5 × ULN within 90 days prior to registration.
* History and physical with Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 or within 90 days prior to registration.
Exclusion Criteria
* Prior invasive malignancy (except non-melanomatous skin cancer carcinoma in situ of the male breast, penis, oral cavity, or stage Ta of the bladder, or stage I completely resected melanoma) unless disease free for a minimum of 2 years).
* Prior systemic chemotherapy for the study cancer. Note: prior chemotherapy for a different cancer is allowable.
* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
* History of any of the following:
* Documented inflammatory bowel disease
* Transmural myocardial infarction within the last 4 months prior to registration.
* New York Heart Association Functional Classification III/IV within 4 months prior to registration.
* Unstable angina and/or congestive heart failure requiring hospitalization within the last 4 months prior to registration
* History of loss of consciousness or transient ischemic attack within 12 months prior to randomization
* History of seizure disorder or condition that may predispose to seizure (e.g. prior cortical stroke or significant brain trauma)
* History of uncontrolled hypertension defined as a sustained systolic blood pressure in excess of 150 mmHg or a sustained diastolic blood pressure in excess of 90 mmHg despite optimized antihypertensive therapy.
* History of repeated falls and fractures over the past 12 months that in the opinion of the treating investigator would put the patient at risk for poor bone outcomes from androgen receptor targeted therapy
* Known gastrointestinal disorder affecting absorption of oral medications.
* Active uncontrolled infection defined as an identified infectious condition that requires active therapy that has not yet been completed.
* HIV positive patients with CD4 count \< 200 cells/microliter within 30 days prior to registration OR HIV patients under treatment with highly active antiretroviral therapy (HAART) within 30 days prior to registration regardless of CD4 count. Note: HIV testing is not required for eligibility for this protocol as it is self-reported. This exclusion criterion is necessary because the treatments involved in this protocol may be immunosuppressive and/or interact with HAART.
18 Years
MALE
No
Sponsors
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Pfizer
INDUSTRY
Astellas Pharma Inc
INDUSTRY
RTOG Foundation, Inc.
OTHER
Responsible Party
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Principal Investigators
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Edwin Posadas, MD
Role: PRINCIPAL_INVESTIGATOR
RTOG Foundation
Hiram Gay, MD
Role: PRINCIPAL_INVESTIGATOR
RTOG Foundation
Locations
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Arizona Center for Cancer Care - Gilbert
Gilbert, Arizona, United States
Arizona Center for Cancer Care - Peoria
Peoria, Arizona, United States
Arizona Center for Cancer Care - Phoenix
Phoenix, Arizona, United States
Arizona Center for Cancer Care - Scottsdale East
Scottsdale, Arizona, United States
Arizona Center for Cancer Care - Scottsdale North
Scottsdale, Arizona, United States
Arizona Center for Cancer Care - Surprise
Surprise, Arizona, United States
Marin Cancer Care, Inc.
Greenbrae, California, United States
Marin Health Medical Center
Greenbrae, California, United States
University of Southern California
Los Angeles, California, United States
USC Medical Center - Los Angeles County
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Roseville Radiation Oncology Center
Roseville, California, United States
Sutter Roseville Medical Center
Roseville, California, United States
Sutter Medical Center Sacramento
Sacramento, California, United States
University of California, San Francisco
San Francisco, California, United States
Valley View Hospital Cancer Center
Glenwood Springs, Colorado, United States
University of Florida Health Science Center
Gainesville, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Nancy N. & J.C. Lewis Cancer & Research Pavilion
Savannah, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Crossroads Cancer Center
Effingham, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
Kansas University Cancer Center Overland Park
Overland Park, Kansas, United States
Kansas University Cancer Center Westwood
Westwood, Kansas, United States
East Jefferson General Hospital
Metairie, Louisiana, United States
LSU Healthcare Network/Metairie Multi-Specialty Clinic
Metairie, Louisiana, United States
Coastal Cancer Treatment Center - Bath
Bath, Maine, United States
Waldo Count General Hospital - Belfast
Belfast, Maine, United States
Maine Health/SMHC Cancer Care and Blood Disorders-Biddeford
Biddeford, Maine, United States
Maine Health/Stephens Memorial - Norway
Norway, Maine, United States
Maine Medical Center - Bramhall S Portland
Portland, Maine, United States
Penobscot Bay Medical Center - Rockport
Rockport, Maine, United States
Maine Health CC of York County - Sanford
Sanford, Maine, United States
Maine Health/SMHCancer Care and Blood Disorders - Sanford
Sanford, Maine, United States
Maine Medical Cancer Center - Scarborough Campus
Scarborough, Maine, United States
Maine Medical Partners - South Portland
South Portland, Maine, United States
McLaren Cancer Institute - Bloomfield
Bloomfield, Michigan, United States
21st Century Oncology MHP - Clarkston
Clarkston, Michigan, United States
McLaren Cancer Institute - Clarkston
Clarkston, Michigan, United States
William Beaumont Hospital - Dearborn
Dearborn, Michigan, United States
Wayne State/Karmanos Cancer Institute
Detroit, Michigan, United States
21st Century Oncology MHP - Farmington
Farmington Hills, Michigan, United States
McLaren Cancer Institute - Flint
Flint, Michigan, United States
Singh and Arora Hematology Oncology PC
Flint, Michigan, United States
McLaren Cancer Institute - Greater Lansing
Lansing, Michigan, United States
Mid-Michigan Physicians - Lansing
Lansing, Michigan, United States
McLaren Cancer Institute - Lapeer Region
Lapeer, Michigan, United States
21st Century Oncology MHP - Macomb
Macomb, Michigan, United States
21st Century Oncology MHP - Madison Heights
Madison Heights, Michigan, United States
McLaren Cancer Institute - Macomb
Mount Clemens, Michigan, United States
McLaren Cancer Institute - Central Michigan
Mount Pleasant, Michigan, United States
McLaren Cancer Institute - Owosso
Owosso, Michigan, United States
McLaren Cancer Institute - Northern Michigan
Petoskey, Michigan, United States
McLaren Cancer Institute - Port Huron
Port Huron, Michigan, United States
William Beaumont Hospital - Royal Oak
Royal Oak, Michigan, United States
William Beaumont Hospital - Troy
Sterling Heights, Michigan, United States
21st Century Oncology MHP - Troy
Troy, Michigan, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Minnesota Oncology Hematology PA - Maplewood
Maplewood, Minnesota, United States
Coborn Cancer Center
Saint Cloud, Minnesota, United States
HealthPartners, Inc.
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
Kansas University Cancer Center North
Kansas City, Missouri, United States
Kansas University Cancer Center Lee's Summit
Lee's Summit, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Exeter Hospital
Exeter, New Hampshire, United States
Dartmouth Hitchcock Medical Center/Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
University Physicians at Oneida
Oneida, New York, United States
Upstate Cancer Center Radiation Oncology at Oneida
Oneida, New York, United States
University Physicians at Oswego
Oswego, New York, United States
Upstate Cancer Radiation Oncology at Oswego
Oswego, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Upstate Cancer Center at Hill Radiation Oncology
Syracuse, New York, United States
UNC Rex Cancer Center
Raleigh, North Carolina, United States
Rex Cancer Center of Wakefield
Raleigh, North Carolina, United States
WellSpan Health - Ephrata Cancer Center
Ephrata, Pennsylvania, United States
WellSpan Health - Adams Cancer Center
Gettysburg, Pennsylvania, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
WellSpan Health - Sechler Family Cancer Center
Lebanon, Pennsylvania, United States
University of Pittsburgh Medical Center - Shadyside Hospital
Pittsburgh, Pennsylvania, United States
WellSpan Health - York Hospital
York, Pennsylvania, United States
Gibbs Cancer Center - Pelham
Greer, South Carolina, United States
Spartanburg Medical Center
Spartanburg, South Carolina, United States
UT Southwestern/Simmons Cancer Center - Dallas
Dallas, Texas, United States
American Fork Hospital
American Fork, Utah, United States
Cedar City Hospital
Cedar City, Utah, United States
Logan Regional Medical Center
Logan, Utah, United States
Intermountain Medical Center
Murray, Utah, United States
Utah Valley Regional Medical Center
Provo, Utah, United States
Dixie Regional Medical Center
St. George, Utah, United States
Dartmouth Hitchcock Medical Center/Norris Cancer Ctr. - St. Johnsbury
Saint Johnsbury, Vermont, United States
Sentara Cancer Institute at Sentara CarePlex Hospital
Hampton, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Sentara Virginia Beach General Hospital
Virginia Beach, Virginia, United States
Aspirus Langlade Hospital
Antigo, Wisconsin, United States
University Cancer Center Johnson Creek
Johnson Creek, Wisconsin, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, United States
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Drexel Town Square
Oak Creek, Wisconsin, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, United States
Froedtert West Bend Hospital
West Bend, Wisconsin, United States
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, United States
CHU de Quebec - L'Hotel-Dieu de Quebec
Québec, Quebec, Canada
CIUSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, , Canada
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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STEEL
Identifier Type: OTHER
Identifier Source: secondary_id
RTOG 3506
Identifier Type: -
Identifier Source: org_study_id