Can a drug combo stop prostate cancer from coming back?

NCT ID NCT03809000

Disease control Sponsor: RTOG Foundation, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is for men whose prostate cancer has returned after surgery, shown by a rising PSA. It compares standard hormone therapy plus radiation to a stronger version that adds enzalutamide. The goal is to see if the enhanced treatment keeps the cancer from progressing longer. About 188 men will take part in this phase 2 trial.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

188 people

The number who actually took part.

Started

Apr 2019

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

Contacts and locations

Locations

21st Century Oncology MHP - Clarkston

Clarkston, Michigan, 48346, United States
21st Century Oncology MHP - Farmington

Farmington Hills, Michigan, 48334, United States
21st Century Oncology MHP - Macomb

Macomb, Michigan, 48044, United States
21st Century Oncology MHP - Madison Heights

Madison Heights, Michigan, 48071, United States
21st Century Oncology MHP - Troy

Troy, Michigan, 48098, United States
AdventHealth Orlando

Orlando, Florida, 32804, United States
American Fork Hospital

American Fork, Utah, 84003, United States
Arizona Center for Cancer Care - Gilbert

Gilbert, Arizona, 85297, United States
Arizona Center for Cancer Care - Peoria

Peoria, Arizona, 85381, United States
Arizona Center for Cancer Care - Phoenix

Phoenix, Arizona, 85027, United States
Arizona Center for Cancer Care - Scottsdale East

Scottsdale, Arizona, 85251, United States
Arizona Center for Cancer Care - Scottsdale North

Scottsdale, Arizona, 85258, United States
Arizona Center for Cancer Care - Surprise

Surprise, Arizona, 85374, United States
Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, 54494, United States
Aspirus Langlade Hospital

Antigo, Wisconsin, 54409, United States
Aspirus Regional Cancer Center

Wausau, Wisconsin, 54401, United States
CHU de Quebec - L'Hotel-Dieu de Quebec

Québec, Quebec, G1R 2J6, Canada
CIUSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

Sherbrooke, J1H 5N4, Canada
Cedar City Hospital

Cedar City, Utah, 84721, United States
Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States
Coastal Cancer Treatment Center - Bath

Bath, Maine, 04530, United States
Coborn Cancer Center

Saint Cloud, Minnesota, 56303, United States
Crossroads Cancer Center

Effingham, Illinois, 62401, United States
Dartmouth Hitchcock Medical Center/Norris Cancer Ctr. - St. Johnsbury

Saint Johnsbury, Vermont, 05819, United States
Dartmouth Hitchcock Medical Center/Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756, United States
Decatur Memorial Hospital

Decatur, Illinois, 62526, United States
Dixie Regional Medical Center

St. George, Utah, 84790, United States
Drexel Town Square

Oak Creek, Wisconsin, 53154, United States
East Jefferson General Hospital

Metairie, Louisiana, 70006, United States
Exeter Hospital

Exeter, New Hampshire, 03833, United States
Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States
Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, 53051, United States
Froedtert West Bend Hospital

West Bend, Wisconsin, 53095, United States
Gibbs Cancer Center - Pelham

Greer, South Carolina, 29650, United States
HealthPartners, Inc.

Saint Louis Park, Minnesota, 55416, United States
Intermountain Medical Center

Murray, Utah, 84107, United States
Kansas University Cancer Center Lee's Summit

Lee's Summit, Missouri, 64064, United States
Kansas University Cancer Center North

Kansas City, Missouri, 64154, United States
Kansas University Cancer Center Overland Park

Overland Park, Kansas, 66210, United States
Kansas University Cancer Center Westwood

Westwood, Kansas, 66205, United States
LSU Healthcare Network/Metairie Multi-Specialty Clinic

Metairie, Louisiana, 70006, United States
Logan Regional Medical Center

Logan, Utah, 84341, United States
Loyola University Medical Center

Maywood, Illinois, 60153, United States
Maine Health CC of York County - Sanford

Sanford, Maine, 04073, United States
Maine Health/SMHC Cancer Care and Blood Disorders-Biddeford

Biddeford, Maine, 04005, United States
Maine Health/SMHCancer Care and Blood Disorders - Sanford

Sanford, Maine, 04073, United States
Maine Health/Stephens Memorial - Norway

Norway, Maine, 04268, United States
Maine Medical Cancer Center - Scarborough Campus

Scarborough, Maine, 04074, United States
Maine Medical Center - Bramhall S Portland

Portland, Maine, 04102, United States
Maine Medical Partners - South Portland

South Portland, Maine, 04106, United States
Marin Cancer Care, Inc.

Greenbrae, California, 94904, United States
Marin Health Medical Center

Greenbrae, California, 94904, United States
McLaren Cancer Institute - Bloomfield

Bloomfield, Michigan, 48302, United States
McLaren Cancer Institute - Central Michigan

Mount Pleasant, Michigan, 48858, United States
McLaren Cancer Institute - Clarkston

Clarkston, Michigan, 48346, United States
McLaren Cancer Institute - Flint

Flint, Michigan, 48532, United States
McLaren Cancer Institute - Greater Lansing

Lansing, Michigan, 48910, United States
McLaren Cancer Institute - Lapeer Region

Lapeer, Michigan, 48446, United States
McLaren Cancer Institute - Macomb

Mount Clemens, Michigan, 48043, United States
McLaren Cancer Institute - Northern Michigan

Petoskey, Michigan, 49770, United States
McLaren Cancer Institute - Owosso

Owosso, Michigan, 48867, United States
McLaren Cancer Institute - Port Huron

Port Huron, Michigan, 48060, United States
Mercy Hospital

Coon Rapids, Minnesota, 55433, United States
Mid-Michigan Physicians - Lansing

Lansing, Michigan, 48912, United States
Minnesota Oncology Hematology PA - Maplewood

Maplewood, Minnesota, 55109, United States
Moffitt Cancer Center

Tampa, Florida, 33612, United States
Nancy N. & J.C. Lewis Cancer & Research Pavilion

Savannah, Georgia, 31405, United States
Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States
Penobscot Bay Medical Center - Rockport

Rockport, Maine, 04856, United States
Regions Hospital

Saint Paul, Minnesota, 55101, United States
Rex Cancer Center of Wakefield

Raleigh, North Carolina, 27614, United States
Roseville Radiation Oncology Center

Roseville, California, 95661, United States
Rush University Medical Center

Chicago, Illinois, 60612, United States
SUNY Upstate Medical University

Syracuse, New York, 13210, United States
Sentara Cancer Institute at Sentara CarePlex Hospital

Hampton, Virginia, 23666, United States
Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States
Sentara Virginia Beach General Hospital

Virginia Beach, Virginia, 23454, United States
Singh and Arora Hematology Oncology PC

Flint, Michigan, 48532, United States
Spartanburg Medical Center

Spartanburg, South Carolina, 29303, United States
Sutter Medical Center Sacramento

Sacramento, California, 95816, United States
Sutter Roseville Medical Center

Roseville, California, 95661, United States
UNC Rex Cancer Center

Raleigh, North Carolina, 27607, United States
USC Medical Center - Los Angeles County

Los Angeles, California, 90033, United States
UT Southwestern/Simmons Cancer Center - Dallas

Dallas, Texas, 75390, United States
University Cancer Center Johnson Creek

Johnson Creek, Wisconsin, 53038, United States
University Physicians at Oneida

Oneida, New York, 13421, United States
University Physicians at Oswego

Oswego, New York, 13126, United States
University of California, San Francisco

San Francisco, California, 94158, United States
University of Florida Health Science Center

Gainesville, Florida, 32608, United States
University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States
University of Pittsburgh Medical Center - Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States
University of Southern California

Los Angeles, California, 90033, United States
University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States
Upstate Cancer Center Radiation Oncology at Oneida

Oneida, New York, 13421, United States
Upstate Cancer Center at Hill Radiation Oncology

Syracuse, New York, 13210, United States
Upstate Cancer Radiation Oncology at Oswego

Oswego, New York, 13126, United States
Utah Valley Regional Medical Center

Provo, Utah, 84604, United States
Valley View Hospital Cancer Center

Glenwood Springs, Colorado, 81601, United States
Waldo Count General Hospital - Belfast

Belfast, Maine, 04915, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States
Wayne State/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States
WellSpan Health - Adams Cancer Center

Gettysburg, Pennsylvania, 17325, United States
WellSpan Health - Ephrata Cancer Center

Ephrata, Pennsylvania, 17522, United States
WellSpan Health - Sechler Family Cancer Center

Lebanon, Pennsylvania, 17402, United States
WellSpan Health - York Hospital

York, Pennsylvania, 17403, United States
William Beaumont Hospital - Dearborn

Dearborn, Michigan, 48124, United States
William Beaumont Hospital - Royal Oak

Royal Oak, Michigan, 48073, United States
William Beaumont Hospital - Troy

Sterling Heights, Michigan, 48314, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.