AzTrials
AzTrials

Prostate CancerPhase 2STEELNCT03809000

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

A Phase 2 study testing Radiation Therapy, Enzalutamide and Bicalutamide in people with Prostate Cancer, run by RTOG Foundation, Inc. at 108 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Radiation Therapy, Enzalutamide and Bicalutamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
188 participants
Where
108 sitesin 2 countries
Study dates
15 Apr 2019to 15 Sep 2029
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 17Show fewer
  • 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.

Who cannot join

  • 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
Show all 16Show fewer
  • 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.

Trial locations and contacts

108 sites in 2 countries.

108 sites in 2 countries

United States106 sites

  • American Fork Hospital

    American Fork, Utah, 84003

  • Aspirus Langlade Hospital

    Antigo, Wisconsin, 54409

  • Coastal Cancer Treatment Center - Bath

    Bath, Maine, 04530

  • Waldo Count General Hospital - Belfast

    Belfast, Maine, 04915

  • Maine Health/SMHC Cancer Care and Blood Disorders-Biddeford

    Biddeford, Maine, 04005

  • McLaren Cancer Institute - Bloomfield

    Bloomfield, Michigan, 48302

  • Cedar City Hospital

    Cedar City, Utah, 84721

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • 21st Century Oncology MHP - Clarkston

    Clarkston, Michigan, 48346

  • McLaren Cancer Institute - Clarkston

    Clarkston, Michigan, 48346

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • UT Southwestern/Simmons Cancer Center - Dallas

    Dallas, Texas, 75390

  • William Beaumont Hospital - Dearborn

    Dearborn, Michigan, 48124

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Wayne State/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • WellSpan Health - Ephrata Cancer Center

    Ephrata, Pennsylvania, 17522

  • Exeter Hospital

    Exeter, New Hampshire, 03833

  • 21st Century Oncology MHP - Farmington

    Farmington Hills, Michigan, 48334

  • McLaren Cancer Institute - Flint

    Flint, Michigan, 48532

  • Singh and Arora Hematology Oncology PC

    Flint, Michigan, 48532

  • University of Florida Health Science Center

    Gainesville, Florida, 32608

  • WellSpan Health - Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Arizona Center for Cancer Care - Gilbert

    Gilbert, Arizona, 85297

  • Valley View Hospital Cancer Center

    Glenwood Springs, Colorado, 81601

  • Marin Cancer Care, Inc.

    Greenbrae, California, 94904

  • Marin Health Medical Center

    Greenbrae, California, 94904

  • Gibbs Cancer Center - Pelham

    Greer, South Carolina, 29650

  • Sentara Cancer Institute at Sentara CarePlex Hospital

    Hampton, Virginia, 23666

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • University Cancer Center Johnson Creek

    Johnson Creek, Wisconsin, 53038

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • Kansas University Cancer Center North

    Kansas City, Missouri, 64154

  • McLaren Cancer Institute - Greater Lansing

    Lansing, Michigan, 48910

  • Mid-Michigan Physicians - Lansing

    Lansing, Michigan, 48912

  • McLaren Cancer Institute - Lapeer Region

    Lapeer, Michigan, 48446

  • Dartmouth Hitchcock Medical Center/Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03756

  • WellSpan Health - Sechler Family Cancer Center

    Lebanon, Pennsylvania, 17402

  • Kansas University Cancer Center Lee's Summit

    Lee's Summit, Missouri, 64064

  • Logan Regional Medical Center

    Logan, Utah, 84341

  • University of Southern California

    Los Angeles, California, 90033

  • USC Medical Center - Los Angeles County

    Los Angeles, California, 90033

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • 21st Century Oncology MHP - Macomb

    Macomb, Michigan, 48044

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • 21st Century Oncology MHP - Madison Heights

    Madison Heights, Michigan, 48071

  • Minnesota Oncology Hematology PA - Maplewood

    Maplewood, Minnesota, 55109

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Froedtert Menomonee Falls Hospital

    Menomonee Falls, Wisconsin, 53051

  • East Jefferson General Hospital

    Metairie, Louisiana, 70006

  • LSU Healthcare Network/Metairie Multi-Specialty Clinic

    Metairie, Louisiana, 70006

  • Froedtert Hospital & the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • McLaren Cancer Institute - Macomb

    Mount Clemens, Michigan, 48043

  • McLaren Cancer Institute - Central Michigan

    Mount Pleasant, Michigan, 48858

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Maine Health/Stephens Memorial - Norway

    Norway, Maine, 04268

  • Drexel Town Square

    Oak Creek, Wisconsin, 53154

  • University Physicians at Oneida

    Oneida, New York, 13421

  • Upstate Cancer Center Radiation Oncology at Oneida

    Oneida, New York, 13421

  • AdventHealth Orlando

    Orlando, Florida, 32804

  • University Physicians at Oswego

    Oswego, New York, 13126

  • Upstate Cancer Radiation Oncology at Oswego

    Oswego, New York, 13126

  • Kansas University Cancer Center Overland Park

    Overland Park, Kansas, 66210

  • McLaren Cancer Institute - Owosso

    Owosso, Michigan, 48867

  • Arizona Center for Cancer Care - Peoria

    Peoria, Arizona, 85381

  • McLaren Cancer Institute - Northern Michigan

    Petoskey, Michigan, 49770

  • Arizona Center for Cancer Care - Phoenix

    Phoenix, Arizona, 85027

  • University of Pittsburgh Medical Center - Shadyside Hospital

    Pittsburgh, Pennsylvania, 15232

  • McLaren Cancer Institute - Port Huron

    Port Huron, Michigan, 48060

  • Maine Medical Center - Bramhall S Portland

    Portland, Maine, 04102

  • Utah Valley Regional Medical Center

    Provo, Utah, 84604

  • UNC Rex Cancer Center

    Raleigh, North Carolina, 27607

  • Rex Cancer Center of Wakefield

    Raleigh, North Carolina, 27614

  • Penobscot Bay Medical Center - Rockport

    Rockport, Maine, 04856

  • Roseville Radiation Oncology Center

    Roseville, California, 95661

  • Sutter Roseville Medical Center

    Roseville, California, 95661

  • William Beaumont Hospital - Royal Oak

    Royal Oak, Michigan, 48073

  • Sutter Medical Center Sacramento

    Sacramento, California, 95816

  • Coborn Cancer Center

    Saint Cloud, Minnesota, 56303

  • Dartmouth Hitchcock Medical Center/Norris Cancer Ctr. - St. Johnsbury

    Saint Johnsbury, Vermont, 05819

  • HealthPartners, Inc.

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • University of California, San Francisco

    San Francisco, California, 94158

  • Maine Health CC of York County - Sanford

    Sanford, Maine, 04073

  • Maine Health/SMHCancer Care and Blood Disorders - Sanford

    Sanford, Maine, 04073

  • Nancy N. & J.C. Lewis Cancer & Research Pavilion

    Savannah, Georgia, 31405

  • Maine Medical Cancer Center - Scarborough Campus

    Scarborough, Maine, 04074

  • Arizona Center for Cancer Care - Scottsdale East

    Scottsdale, Arizona, 85251

  • Arizona Center for Cancer Care - Scottsdale North

    Scottsdale, Arizona, 85258

  • Maine Medical Partners - South Portland

    South Portland, Maine, 04106

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Dixie Regional Medical Center

    St. George, Utah, 84790

  • William Beaumont Hospital - Troy

    Sterling Heights, Michigan, 48314

  • Arizona Center for Cancer Care - Surprise

    Surprise, Arizona, 85374

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Upstate Cancer Center at Hill Radiation Oncology

    Syracuse, New York, 13210

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • 21st Century Oncology MHP - Troy

    Troy, Michigan, 48098

  • Sentara Virginia Beach General Hospital

    Virginia Beach, Virginia, 23454

  • Aspirus Regional Cancer Center

    Wausau, Wisconsin, 54401

  • Froedtert West Bend Hospital

    West Bend, Wisconsin, 53095

  • Kansas University Cancer Center Westwood

    Westwood, Kansas, 66205

  • Aspirus Cancer Care - Wisconsin Rapids

    Wisconsin Rapids, Wisconsin, 54494

  • WellSpan Health - York Hospital

    York, Pennsylvania, 17403

Other trials in United States

Canada2 sites

  • CHU de Quebec - L'Hotel-Dieu de Quebec

    Québec, Quebec, G1R 2J6

  • CIUSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

    Sherbrooke, J1H 5N4

Other trials in Canada

About this study

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

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.

Read the 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.

Conditions
Prostate Cancer
Being tested
Radiation Therapy, Enzalutamide, Bicalutamide, GnRH analog
Keywords
Post-prostatectomy, Enzalutamide, STEEL
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiation TherapyRadiation

    Also called RT, Image-Guided Radiation Therapy (IGRT), Radiotherapy

    daily fractions

  • EnzalutamideDrug

    Also called Xtandi®

    tablet

  • BicalutamideDrug

    Also called Casodex®

    tablet

  • GnRH analogDrug

    Also called Gonadotropin-releasing hormone analog, Lupron®, leuprolide acetate, goserelin acetate

    Injection

Study groups in NCT03809000
Study groupRoleWhat they receive
Salvage Radiation Therapy (SRT) + Standard androgen deprivation therapy (ADT)Active comparatorStandard 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.
Receives: Radiation: Radiation Therapy; Drug: Bicalutamide; Drug: GnRH analog
Salvage Radiation Therapy + Enhanced ADTExperimentalEnhanced 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.
Receives: Radiation: Radiation Therapy; Drug: Enzalutamide; Drug: GnRH analog

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Alive Without Progression (Progression-Free Survival)

    Progression-free survival (PFS) is estimated by the Kaplan-Meier method. PFS time is measured from randomization to the date of first PFS failure (biochemical or clinical failure, initiation of new unplanned anticancer treatment, or death from any cause) or last known follow-up (censored). Analysis was to occur after progression or death was reported for 101 participants. Biochemical failure is defined as first post-RT detectable PSA (PSA ≥ 0.05). Clinical failure is defined as either a local, regional, or distant failure.

    Measured: From randomization to first failure or last known follow-up. Median follow-up time at the time of analysis was 33.1 months. The 1- and 2-year estimates are reported.

Secondary outcomes (16)

  1. Percentage of Participants With Biochemical Failure

    Biochemical failure is defined as the first detectable post-RT prostate-specific antigen (PSA) value (≥ 0.05) or the initiation of salvage hormone therapy. Failure rates are estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive at time of analysis.

    Measured: From randomization to first failure, competing event, or last known follow-up, whichever occurs first. Median follow-up time at the time of analysis was 33.1 months. The 1- and 2-year estimates are reported.

  2. Percentage of Participants With Alternative Biochemical Failure

    Alternative biochemical failure is defined as first post-RT PSA ≥ 0.1 ng/mL or initiation of salvage hormone therapy. Failure rates are estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive at time of analysis.

    Measured: From randomization to first failure, competing event, or last known follow-up, whichever occurs first. Median follow-up time at the time of analysis was 33.1 months. The 1- and 2-year estimates are reported.

  3. Percentage of Participants With Hormone-refractory Disease

    Hormone-refractory disease is defined as three rises in PSA during salvage androgen deprivation, with the date determined as the midway date between the last non-rising PSA and the first of the three rises. Failure rates were to be estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive at time of analysis, but for endpoints with < 10 events overall, such as this one, only the counts of participants with the event are provided.

    Measured: From randomization to first failure, competing event, or last known follow-up, whichever occurs first. Median follow-up time at the time of analysis was 33.1 months.

  4. Percentage of Participants With Distant Metastasis

    Distant failure is defined as first radiographic evidence of distant metastasis (e.g., bone scan, computed tomography (CT), magnetic resonance imaging (MRI)). Failure rates were to be estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive at time of analysis, but for endpoints with < 10 events overall, such as this one, only the counts of participants with the event are provided.

    Measured: From randomization to first failure, competing event, or last known follow-up, whichever occurs first. Median follow-up time at the time of analysis was 33.1 months.

  5. Percentage of Participants With Prostate Cancer Death

    Cause-specific mortality is defined as death due to prostate cancer. Failure rates were to be estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive at time of analysis, but for endpoints with < 10 events overall, such as this one, only the counts of participants with the event are provided.

    Measured: From randomization to first failure, competing event, or last known follow-up, whichever occurs first. Median follow-up time at the time of analysis was 33.1 months.

  6. Percentage of Participants Alive (Overall Survival)

    Survival rates were to be estimated using the Kaplan-Meier method, censoring participants alive at time of analysis, but for endpoints with < 10 events overall, such as this one, only counts are provided. In this case, the number of participants without event (death), which is the number of participants alive.

    Measured: From randomization to death or last known follow-up, whichever occurs first. Median follow-up time at the time of analysis was 33.1 months.

  7. Change From Baseline to End of RT in the 5-level European Quality of Life Questionnaire (EQ-5D-5L) Index Score

    The EQ-5D-5L is a self-assessment questionnaire. The index score is computed from 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). Change score was calculated by subtracting baseline from later score, with a positive change score indicating improvement.

    Measured: Baseline and end of radiation treatment (RT). End of RT can vary greatly depending on when it starts, which can be from 0 to 70 days from the start of ADT, and lasting 7-8 weeks.

  8. Change From Baseline to One Year After End of RT in the EQ-5D-5L Index Score

    The EQ-5D-5L is a self-assessment questionnaire. The index score is computed from 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). Change score was calculated by subtracting baseline from later score, with a positive change score indicating improvement.

    Measured: Baseline and one year after end RT. End of RT can vary greatly depending on when it starts, which can be from 0 to 70 days from the start of ADT, and lasting 7-8 weeks.

  9. Change From Baseline to Two Years After End of RT in the EQ-5D-5L Index Score

    The EQ-5D-5L is a self-assessment questionnaire. The index score is computed from 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). Change score was calculated by subtracting baseline from later score, with a positive change score indicating improvement.

    Measured: Baseline and two years after end of RT. End of RT can vary greatly depending on when it starts, which can be from 0 to 70 days from the start of ADT, and lasting 7-8 weeks.

  10. Change From Baseline to End of RT in the 7-item Patient Reported Outcomes Measurement Information System - Fatigue Short Form (PROMIS-F SF 7a) [PROMIS Fatigue Score]

    The PROMIS fatigue score measures self-reported fatigue symptoms over the past 7 days. Possible raw scores range from 29.4 to 83.2 (higher raw score indicating greater fatigue) and are converted into standardized T-scores (mean=50, standard deviation=10) with higher scores also indicating greater fatigue. Change score is calculated by subtracting baseline T-score from later T-score, with a positive change score indicating increased fatigue.

    Measured: Baseline and end of RT. End of RT can vary greatly depending on when it starts, which can be from 0 to 70 days from the start of ADT, and lasting 7-8 weeks.

  11. Change From Baseline to One Year After the End of RT in the 7-item Patient Reported Outcomes Measurement Information System - Fatigue Short Form (PROMIS-F SF 7a) [PROMIS Fatigue Score]

    The PROMIS fatigue score measures self-reported fatigue symptoms over the past 7 days. Possible raw scores range from 29.4 to 83.2 (higher raw score indicating greater fatigue) and are converted into standardized T-scores (mean=50, standard deviation=10) with higher scores also indicating greater fatigue. Change score is calculated by subtracting baseline T-score from later T-score, with a positive change score indicating increased fatigue.

    Measured: Baseline and one year after end of RT. End of RT can vary greatly depending on when it starts, which can be from 0 to 70 days from the start of ADT, and lasting 7-8 weeks.

  12. Change From Baseline to Two Years After the End of RT in the 7-item Patient Reported Outcomes Measurement Information System - Fatigue Short Form (PROMIS-F SF 7a) [PROMIS Fatigue Score]

    The PROMIS fatigue score measures self-reported fatigue symptoms over the past 7 days. Possible raw scores range from 29.4 to 83.2 (higher raw score indicating greater fatigue) and are converted into standardized T-scores (mean=50, standard deviation=10) with higher scores also indicating greater fatigue. Change score is calculated by subtracting baseline T-score from later T-score, with a positive change score indicating increased fatigue.

    Measured: Baseline, two years after end of RT. End of RT can vary greatly depending on when it starts, which can be from 0 to 70 days from the start of ADT, and lasting 7-8 weeks.

  13. Number of Participants by Highest Grade Adverse Event Reported CTCAE v5

    Common Terminology Criteria for Adverse Events (version 5) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.

    Measured: From randomization to death or last known follow-up. Median follow-up time at the time of analysis was 33.1 months.

  14. Number of Participants Any Adverse Event Occuring Within 30 Days Following the End of Treatment

    Common Terminology Criteria for Adverse Events (version 5) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.

    Measured: From randomization to 30 days after the end of RT. End of RT can vary greatly depending on when it starts, which can be from 0 to 70 days from the start of ADT, and lasting 7-8 weeks.

  15. Number of Participants With Any Grade 3+ Adverse Event Occuring After 30 Days Following the End of RT

    Common Terminology Criteria for Adverse Events (version 5) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.

    Measured: From 31 days after the end of RT to death or last known follow-up. Median follow-up was 33.1 months. End of RT can vary greatly depending on when it starts, which can be from 0 to 70 days from the start of ADT, and lasting 7-8 weeks.

  16. Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3

    PRO-CTCAE is a patient-reported outcome (PRO) measurement system developed to evaluate symptomatic toxicity in patients on cancer clinical trials, asking the patient about experience over the last seven days. Scores may reflect worst severity of the symptom (0=None, 1=Mild, 2=Moderate, 3=Severe, and 4=Very severe), frequency of the symptom (0=Never, 1=Rarely, 2=Occasionally, 3=Frequently, 4=Almost constantly), or the symptom's interference with one's "usual or daily activities" (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). The symptom row title will indicate "Severity", "Frequency", or "Interference". All scores are compared between arms; statistical analysis results are entered for p-values < 0.05.

    Measured: End of RT, one and two years after the end of RT. End of RT can vary greatly depending on when it starts, which can be from 0 to 70 days from the start of ADT, and lasting 7-8 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2019
  2. Study start15 Apr 2019
  3. Primary completion7 Apr 2023
  4. Study completion15 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
188 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03809000
Sponsor's protocol ID
RTOG 3506
Other IDs
STEEL
Acronym
STEEL
Status last verified
Nov 2025
First submitted
16 Jan 2019
Last updated
30 Dec 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Morgan TM, Boorjian SA, Buyyounouski MK, Chapin BF, Chen DYT, Cheng HH, Chou R, Jacene HA, Kamran SC, Kim SK, Kirkby E, Luckenbaugh AN, Nathanson BJ, Nyame YA, Posadas EM, Tran PT, Chen RC. Salvage Therapy for Prostate Cancer: AUA/ASTRO/SUO Guideline Part II: Treatment Delivery for Non-metastatic Biochemical Recurrence After Primary Radical Prostatectomy. J Urol. 2024 Apr;211(4):518-525. doi: 10.1097/JU.0000000000003891. Epub 2024 Feb 29.

    PubMed 38421243

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radiation Therapy, Enzalutamide and Bicalutamide in people with Prostate Cancer, run by RTOG Foundation, Inc. at 108 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 108 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Alive Without Progression (Progression-Free Survival) (time frame: From randomization to first failure or last known follow-up. Median follow-up time at the time of analysis was 33.1 months. The 1- and 2-year estimates are reported.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03809000, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.

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