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

February 2, 2024 updated by: RTOG Foundation, Inc.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

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.

Study Type

Interventional

Enrollment (Actual)

188

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
      • Sherbrooke, Canada, J1H 5N4
        • CIUSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
    • Quebec
      • Québec City, Quebec, Canada, G1R 2J6
        • CHU de Quebec - L'Hotel-Dieu de Quebec
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Arizona Center for Cancer Care - Gilbert
      • Peoria, Arizona, United States, 85381
        • Arizona Center for Cancer Care - Peoria
      • Phoenix, Arizona, United States, 85027
        • Arizona Center for Cancer Care - Phoenix
      • Scottsdale, Arizona, United States, 85251
        • Arizona Center for Cancer Care - Scottsdale East
      • Scottsdale, Arizona, United States, 85258
        • Arizona Center for Cancer Care - Scottsdale North
      • Surprise, Arizona, United States, 85374
        • Arizona Center for Cancer Care - Surprise
    • California
      • Greenbrae, California, United States, 94904
        • Marin Cancer Care, Inc.
      • Greenbrae, California, United States, 94904
        • Marin Health Medical Center
      • Los Angeles, California, United States, 90033
        • University of Southern California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90033
        • USC Medical Center - Los Angeles County
      • Roseville, California, United States, 95661
        • Sutter Roseville Medical Center
      • Roseville, California, United States, 95661
        • Roseville Radiation Oncology Center
      • Sacramento, California, United States, 95816
        • Sutter Medical Center Sacramento
      • San Francisco, California, United States, 94158
        • University of California, San Francisco
    • Colorado
      • Glenwood Springs, Colorado, United States, 81601
        • Valley View Hospital Cancer Center
    • Florida
      • Gainesville, Florida, United States, 32608
        • University of Florida Health Science Center
      • Orlando, Florida, United States, 32804
        • AdventHealth Orlando
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Georgia
      • Savannah, Georgia, United States, 31405
        • Nancy N. & J.C. Lewis Cancer & Research Pavilion
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital
      • Effingham, Illinois, United States, 62401
        • Crossroads Cancer Center
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Cancer Center
      • Overland Park, Kansas, United States, 66210
        • Kansas University Cancer Center Overland Park
      • Westwood, Kansas, United States, 66205
        • Kansas University Cancer Center Westwood
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • East Jefferson General Hospital
      • Metairie, Louisiana, United States, 70006
        • LSU Healthcare Network/Metairie Multi-Specialty Clinic
    • Maine
      • Bath, Maine, United States, 04530
        • Coastal Cancer Treatment Center - Bath
      • Belfast, Maine, United States, 04915
        • Waldo Count General Hospital - Belfast
      • Biddeford, Maine, United States, 04005
        • Maine Health/SMHC Cancer Care and Blood Disorders-Biddeford
      • Norway, Maine, United States, 04268
        • Maine Health/Stephens Memorial - Norway
      • Portland, Maine, United States, 04102
        • Maine Medical Center - Bramhall S Portland
      • Rockport, Maine, United States, 04856
        • Penobscot Bay Medical Center - Rockport
      • Sanford, Maine, United States, 04073
        • Maine Health CC of York County - Sanford
      • Sanford, Maine, United States, 04073
        • Maine Health/SMHCancer Care and Blood Disorders - Sanford
      • Scarborough, Maine, United States, 04074
        • Maine Medical Cancer Center - Scarborough Campus
      • South Portland, Maine, United States, 04106
        • Maine Medical Partners - South Portland
    • Michigan
      • Bloomfield, Michigan, United States, 48302
        • McLaren Cancer Institute - Bloomfield
      • Clarkston, Michigan, United States, 48346
        • 21st Century Oncology MHP - Clarkston
      • Clarkston, Michigan, United States, 48346
        • McLaren Cancer Institute - Clarkston
      • Dearborn, Michigan, United States, 48124
        • William Beaumont Hospital - Dearborn
      • Detroit, Michigan, United States, 48201
        • Wayne State/Karmanos Cancer Institute
      • Farmington Hills, Michigan, United States, 48334
        • 21st Century Oncology MHP - Farmington
      • Flint, Michigan, United States, 48532
        • Singh and Arora Hematology Oncology PC
      • Flint, Michigan, United States, 48532
        • McLaren Cancer Institute - Flint
      • Lansing, Michigan, United States, 48910
        • McLaren Cancer Institute - Greater Lansing
      • Lansing, Michigan, United States, 48912
        • Mid-Michigan Physicians - Lansing
      • Lapeer, Michigan, United States, 48446
        • McLaren Cancer Institute - Lapeer Region
      • Macomb, Michigan, United States, 48044
        • 21st Century Oncology MHP - Macomb
      • Madison Heights, Michigan, United States, 48071
        • 21st Century Oncology MHP - Madison Heights
      • Mount Clemens, Michigan, United States, 48043
        • McLaren Cancer Institute - Macomb
      • Mount Pleasant, Michigan, United States, 48858
        • McLaren Cancer Institute - Central Michigan
      • Owosso, Michigan, United States, 48867
        • McLaren Cancer Institute - Owosso
      • Petoskey, Michigan, United States, 49770
        • McLaren Cancer Institute - Northern Michigan
      • Port Huron, Michigan, United States, 48060
        • McLaren Cancer Institute - Port Huron
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital - Royal Oak
      • Sterling Heights, Michigan, United States, 48314
        • William Beaumont Hospital - Troy
      • Troy, Michigan, United States, 48098
        • 21st Century Oncology MHP - Troy
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy Hospital
      • Maplewood, Minnesota, United States, 55109
        • Minnesota Oncology Hematology PA - Maplewood
      • Saint Cloud, Minnesota, United States, 56303
        • Coborn Cancer Center
      • Saint Louis Park, Minnesota, United States, 55416
        • HealthPartners, Inc.
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64154
        • Kansas University Cancer Center North
      • Lee's Summit, Missouri, United States, 64064
        • Kansas University Cancer Center Lee's Summit
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Hampshire
      • Exeter, New Hampshire, United States, 03833
        • Exeter Hospital
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center/Norris Cotton Cancer Center
    • New York
      • Oneida, New York, United States, 13421
        • Upstate Cancer Center Radiation Oncology at Oneida
      • Oneida, New York, United States, 13421
        • University Physicians at Oneida
      • Oswego, New York, United States, 13126
        • University Physicians at Oswego
      • Oswego, New York, United States, 13126
        • Upstate Cancer Radiation Oncology at Oswego
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
      • Syracuse, New York, United States, 13210
        • Upstate Cancer Center at Hill Radiation Oncology
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • UNC REX Cancer Center
      • Raleigh, North Carolina, United States, 27614
        • Rex Cancer Center of Wakefield
    • Pennsylvania
      • Ephrata, Pennsylvania, United States, 17522
        • WellSpan Health - Ephrata Cancer Center
      • Gettysburg, Pennsylvania, United States, 17325
        • WellSpan Health - Adams Cancer Center
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton S. Hershey Medical Center
      • Lebanon, Pennsylvania, United States, 17402
        • WellSpan Health - Sechler Family Cancer Center
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Medical Center - Shadyside Hospital
      • York, Pennsylvania, United States, 17403
        • WellSpan Health - York Hospital
    • South Carolina
      • Greer, South Carolina, United States, 29650
        • Gibbs Cancer Center - Pelham
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Medical Center
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern/Simmons Cancer Center - Dallas
    • Utah
      • American Fork, Utah, United States, 84003
        • American Fork Hospital
      • Cedar City, Utah, United States, 84721
        • Cedar City Hospital
      • Logan, Utah, United States, 84341
        • Logan Regional Medical Center
      • Murray, Utah, United States, 84107
        • Intermountain Medical Center
      • Provo, Utah, United States, 84604
        • Utah Valley Regional Medical Center
      • Saint George, Utah, United States, 84790
        • Dixie Regional Medical Center
    • Vermont
      • Saint Johnsbury, Vermont, United States, 05819
        • Dartmouth Hitchcock Medical Center/Norris Cancer Ctr. - St. Johnsbury
    • Virginia
      • Hampton, Virginia, United States, 23666
        • Sentara Cancer Institute at Sentara CarePlex Hospital
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General Hospital
      • Virginia Beach, Virginia, United States, 23454
        • Sentara Virginia Beach General Hospital
    • Wisconsin
      • Antigo, Wisconsin, United States, 54409
        • Aspirus Langlade Hospital
      • Johnson Creek, Wisconsin, United States, 53038
        • University Cancer Center Johnson Creek
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital and Clinics
      • Menomonee Falls, Wisconsin, United States, 53051
        • Froedtert Menomonee Falls Hospital
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Hospital & the Medical College of Wisconsin
      • Oak Creek, Wisconsin, United States, 53154
        • Drexel Town Square
      • Wausau, Wisconsin, United States, 54401
        • Aspirus Regional Cancer Center
      • West Bend, Wisconsin, United States, 53095
        • Froedtert West Bend Hospital
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Aspirus Cancer Care - Wisconsin Rapids

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.
  • 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 [AJCC v8.0] is eligible but a pT stage

      ≥ pT3b is considered aggressive)

    • Locoregional node involvement at radical prostatectomy (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
  • 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 × 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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Salvage Radiation Therapy + Standard ADT
Salvage RT will be given 66.0 - 70.2 Gy along with 24 months of a GnRH analog with or without 1-4 months of bicalutamide.
Radiation: Radiation Therapy
Radiation Therapy
Other Names:
  • Radiotherapy
  • RT
  • Three-Dimensional Conformal Radiation Therapy (3D-CRT)
  • Intensity-Modulated Radiation Therapy (IMRT)
  • Image-Guided Radiation Therapy (IGRT)
Drug: Bicalutamide
Anti-androgen
Other Names:
  • Casodex®
Drug: GnRH analog
Anti-androgen
Other Names:
  • leuprolide acetate
  • goserelin acetate
  • Trelstar®
  • Gonadotropin-releasing hormone analog
  • Lupron®
  • Eligard™
  • Viadur™
  • Zoldaex®
Experimental: Salvage Radiation Therapy + Enhanced ADT
Salvage RT will be given 66.0 - 70.2 Gy along with 24 months of a GnRH analog + 24 months of enzalutamide.
Radiation: Radiation Therapy
Radiation Therapy
Other Names:
  • Radiotherapy
  • RT
  • Three-Dimensional Conformal Radiation Therapy (3D-CRT)
  • Intensity-Modulated Radiation Therapy (IMRT)
  • Image-Guided Radiation Therapy (IGRT)
Drug: GnRH analog
Anti-androgen
Other Names:
  • leuprolide acetate
  • goserelin acetate
  • Trelstar®
  • Gonadotropin-releasing hormone analog
  • Lupron®
  • Eligard™
  • Viadur™
  • Zoldaex®
Drug: Enzalutamide
Anti-androgen
Other Names:
  • Xtandi®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: From the date of randomization to the date of progression, death from any cause or last known follow-up date, assessed up to 5 years.
The time from the date of randomization to the date of progression, death from any cause or last known follow-up date.
From the date of randomization to the date of progression, death from any cause or last known follow-up date, assessed up to 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RTOG Foundation, Inc.

Collaborators

Pfizer
Astellas Pharma Inc

Investigators

  • Principal Investigator: Edwin Posadas, MD, RTOG Foundation
  • Principal Investigator: Hiram Gay, MD, RTOG Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2019

Primary Completion (Actual)

April 7, 2023

Study Completion (Estimated)

September 15, 2029

Study Registration Dates

First Submitted

January 16, 2019

First Submitted That Met QC Criteria

January 16, 2019

First Posted (Actual)

January 18, 2019

Study Record Updates

Last Update Posted (Actual)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 2, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTOG 3506
  • STEEL (Other Identifier: RTOG Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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