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ACTIVE NOT RECRUITING

NCT03809000

PHASE2

A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery

Sponsor: RTOG Foundation, Inc.

View on ClinicalTrials.gov

Summary

Patients with post-prostatectomy PSA (Prostate Specific Antigen) recurrences with aggressive disease features will receive salvage radiation therapy and standard androgen deprivation therapy (ADT) or enhanced ADT to determine if there is any improvement in progression-free survival when enhanced ADT is used compared to standard ADT.

Official title: STEEL: A Randomized Phase II Trial of Salvage Radiotherapy With Standard vs Enhanced Androgen Deprivation Therapy (With Enzalutamide) in Patients With Post-Prostatectomy PSA Recurrences With Aggressive Disease Features

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

188

Start Date

2019-04-15

Completion Date

2029-09-15

Last Updated

2025-12-30

Healthy Volunteers

Conditions

Prostate Cancer

Interventions

RADIATION

Radiation Therapy

daily fractions

DRUG

Enzalutamide

tablet

DRUG

Bicalutamide

tablet

DRUG

GnRH analog

Injection

Inclusion Criteria: * Pathologically (histologically) proven adenocarcinoma confirmed by prostatectomy performed within 10 years prior to registration and any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted. * 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: * Definitive clinical or radiologic evidence of metastatic disease with the exception of locoregional lymph nodes. * 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.

Locations (108)

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

Clinical Research Directory

A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (108)