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

Sponsor
RTOG Foundation, Inc. (Other)
Overall Status
Recruiting
CT.gov ID
NCT03809000
Collaborator
Pfizer (Industry), Astellas Pharma Inc (Industry)
242
Enrollment
108
Locations
2
Arms
125
Anticipated Duration (Months)
2.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
242 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 15, 2019
Anticipated Primary Completion Date :
Sep 15, 2024
Anticipated Study Completion Date :
Sep 15, 2029

Arms and Interventions

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:
  • RT
  • Three-Dimensional Conformal Radiation Therapy (3D-CRT)
  • Intensity-Modulated Radiation Therapy (IMRT)
  • Image-Guided Radiation Therapy (IGRT)
  • Radiotherapy

    • Drug: Bicalutamide
    Anti-androgen
    Other Names:
  • Casodex®

    • Drug: GnRH analog
    Anti-androgen
    Other Names:
  • Gonadotropin-releasing hormone analog
  • Lupron®
  • leuprolide acetate
  • goserelin acetate
  • Eligard™
  • Viadur™
  • Zoldaex®
  • Trelstar®

    		•
    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:
  • RT
  • Three-Dimensional Conformal Radiation Therapy (3D-CRT)
  • Intensity-Modulated Radiation Therapy (IMRT)
  • Image-Guided Radiation Therapy (IGRT)
  • Radiotherapy

    • Drug: Enzalutamide
    Anti-androgen
    Other Names:
  • Xtandi®

    • Drug: GnRH analog
    Anti-androgen
    Other Names:
  • Gonadotropin-releasing hormone analog
  • Lupron®
  • leuprolide acetate
  • goserelin acetate
  • Eligard™
  • Viadur™
  • Zoldaex®
  • Trelstar®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression-Free Survival (PFS) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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 90 days prior to registration. GnRH analog may be started no more than 42 days prior study entry, but patients must have a PSA ≥ 0.2 ng/mL prior to starting ADT.

    • 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

    • 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.

    • Testosterone >50 ng/dL within 90 days prior to registration. Prior androgen deprivation (GnRH analog and/or non-steroidal antiandrogen) therapy is allowed provided that serum testosterone concentration must be ≥ 50 ng/dL prior to registration or starting ADT, whichever occurs first; 5-alpha reductase inhibitors will not impact eligibility, but must be discontinued prior to starting protocol treatment.

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Center for Cancer Care - Gilbert Gilbert Arizona United States 85297
    2 Arizona Center for Cancer Care - Peoria Peoria Arizona United States 85381
    3 Arizona Center for Cancer Care - Phoenix Phoenix Arizona United States 85027
    4 Arizona Center for Cancer Care - Scottsdale East Scottsdale Arizona United States 85251
    5 Arizona Center for Cancer Care - Scottsdale North Scottsdale Arizona United States 85258
    6 Arizona Center for Cancer Care - Surprise Surprise Arizona United States 85374
    7 Marin Cancer Care, Inc. Greenbrae California United States 94904
    8 Marin Health Medical Center Greenbrae California United States 94904
    9 University of Southern California Los Angeles California United States 90033
    10 USC Medical Center - Los Angeles County Los Angeles California United States 90033
    11 Cedars-Sinai Medical Center Los Angeles California United States 90048
    12 Roseville Radiation Oncology Center Roseville California United States 95661
    13 Sutter Roseville Medical Center Roseville California United States 95661
    14 Sutter Medical Center Sacramento Sacramento California United States 95816
    15 University of California, San Francisco San Francisco California United States 94158
    16 Valley View Hospital Cancer Center Glenwood Springs Colorado United States 81601
    17 University of Florida Health Science Center Gainesville Florida United States 32608
    18 AdventHealth Orlando Orlando Florida United States 32804
    19 Moffitt Cancer Center Tampa Florida United States 33612
    20 Nancy N. & J.C. Lewis Cancer & Research Pavilion Savannah Georgia United States 31405
    21 Rush University Medical Center Chicago Illinois United States 60612
    22 Decatur Memorial Hospital Decatur Illinois United States 62526
    23 Crossroads Cancer Center Effingham Illinois United States 62401
    24 Loyola University Medical Center Maywood Illinois United States 60153
    25 University of Kansas Cancer Center Kansas City Kansas United States 66160
    26 Kansas University Cancer Center Overland Park Overland Park Kansas United States 66210
    27 Kansas University Cancer Center Westwood Westwood Kansas United States 66205
    28 East Jefferson General Hospital Metairie Louisiana United States 70006
    29 LSU Healthcare Network/Metairie Multi-Specialty Clinic Metairie Louisiana United States 70006
    30 Coastal Cancer Treatment Center - Bath Bath Maine United States 04530
    31 Waldo Count General Hospital - Belfast Belfast Maine United States 04915
    32 Maine Health/SMHC Cancer Care and Blood Disorders-Biddeford Biddeford Maine United States 04005
    33 Maine Health/Stephens Memorial - Norway Norway Maine United States 04268
    34 Maine Medical Center - Bramhall S Portland Portland Maine United States 04102
    35 Penobscot Bay Medical Center - Rockport Rockport Maine United States 04856
    36 Maine Health CC of York County - Sanford Sanford Maine United States 04073
    37 Maine Health/SMHCancer Care and Blood Disorders - Sanford Sanford Maine United States 04073
    38 Maine Medical Cancer Center - Scarborough Campus Scarborough Maine United States 04074
    39 Maine Medical Partners - South Portland South Portland Maine United States 04106
    40 McLaren Cancer Institute - Bloomfield Bloomfield Michigan United States 48302
    41 21st Century Oncology MHP - Clarkston Clarkston Michigan United States 48346
    42 McLaren Cancer Institute - Clarkston Clarkston Michigan United States 48346
    43 William Beaumont Hospital - Dearborn Dearborn Michigan United States 48124
    44 Wayne State/Karmanos Cancer Institute Detroit Michigan United States 48201
    45 21st Century Oncology MHP - Farmington Farmington Hills Michigan United States 48334
    46 McLaren Cancer Institute - Flint Flint Michigan United States 48532
    47 Singh and Arora Hematology Oncology PC Flint Michigan United States 48532
    48 McLaren Cancer Institute - Greater Lansing Lansing Michigan United States 48910
    49 Mid-Michigan Physicians - Lansing Lansing Michigan United States 48912
    50 McLaren Cancer Institute - Lapeer Region Lapeer Michigan United States 48446
    51 21st Century Oncology MHP - Macomb Macomb Michigan United States 48044
    52 21st Century Oncology MHP - Madison Heights Madison Heights Michigan United States 48071
    53 McLaren Cancer Institute - Macomb Mount Clemens Michigan United States 48043
    54 McLaren Cancer Institute - Central Michigan Mount Pleasant Michigan United States 48858
    55 McLaren Cancer Institute - Owosso Owosso Michigan United States 48867
    56 McLaren Cancer Institute - Northern Michigan Petoskey Michigan United States 49770
    57 McLaren Cancer Institute - Port Huron Port Huron Michigan United States 48060
    58 William Beaumont Hospital - Royal Oak Royal Oak Michigan United States 48073
    59 William Beaumont Hospital - Troy Sterling Heights Michigan United States 48314
    60 21st Century Oncology MHP - Troy Troy Michigan United States 48098
    61 Mercy Hospital Coon Rapids Minnesota United States 55433
    62 Minnesota Oncology Hematology PA - Maplewood Maplewood Minnesota United States 55109
    63 Coborn Cancer Center Saint Cloud Minnesota United States 56303
    64 HealthPartners, Inc. Saint Louis Park Minnesota United States 55416
    65 Regions Hospital Saint Paul Minnesota United States 55101
    66 Kansas University Cancer Center North Kansas City Missouri United States 64154
    67 Kansas University Cancer Center Lee's Summit Lee's Summit Missouri United States 64064
    68 Washington University School of Medicine Saint Louis Missouri United States 63110
    69 Exeter Hospital Exeter New Hampshire United States 03833
    70 Dartmouth Hitchcock Medical Center/Norris Cotton Cancer Center Lebanon New Hampshire United States 03756
    71 University Physicians at Oneida Oneida New York United States 13421
    72 Upstate Cancer Center Radiation Oncology at Oneida Oneida New York United States 13421
    73 University Physicians at Oswego Oswego New York United States 13126
    74 Upstate Cancer Radiation Oncology at Oswego Oswego New York United States 13126
    75 SUNY Upstate Medical University Syracuse New York United States 13210
    76 Upstate Cancer Center at Hill Radiation Oncology Syracuse New York United States 13210
    77 UNC Rex Cancer Center Raleigh North Carolina United States 27607
    78 Rex Cancer Center of Wakefield Raleigh North Carolina United States 27614
    79 WellSpan Health - Ephrata Cancer Center Ephrata Pennsylvania United States 17522
    80 WellSpan Health - Adams Cancer Center Gettysburg Pennsylvania United States 17325
    81 Penn State Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033
    82 WellSpan Health - Sechler Family Cancer Center Lebanon Pennsylvania United States 17402
    83 University of Pittsburgh Medical Center - Shadyside Hospital Pittsburgh Pennsylvania United States 15232
    84 WellSpan Health - York Hospital York Pennsylvania United States 17403
    85 Gibbs Cancer Center - Pelham Greer South Carolina United States 29650
    86 Spartanburg Medical Center Spartanburg South Carolina United States 29303
    87 UT Southwestern/Simmons Cancer Center - Dallas Dallas Texas United States 75390
    88 American Fork Hospital American Fork Utah United States 84003
    89 Cedar City Hospital Cedar City Utah United States 84721
    90 Logan Regional Medical Center Logan Utah United States 84341
    91 Intermountain Medical Center Murray Utah United States 84107
    92 Utah Valley Regional Medical Center Provo Utah United States 84604
    93 Dixie Regional Medical Center Saint George Utah United States 84790
    94 Dartmouth Hitchcock Medical Center/Norris Cancer Ctr. - St. Johnsbury Saint Johnsbury Vermont United States 05819
    95 Sentara Cancer Institute at Sentara CarePlex Hospital Hampton Virginia United States 23666
    96 Sentara Norfolk General Hospital Norfolk Virginia United States 23507
    97 Sentara Virginia Beach General Hospital Virginia Beach Virginia United States 23454
    98 Aspirus Langlade Hospital Antigo Wisconsin United States 54409
    99 University Cancer Center Johnson Creek Johnson Creek Wisconsin United States 53038
    100 University of Wisconsin Hospital and Clinics Madison Wisconsin United States 53792
    101 Froedtert Menomonee Falls Hospital Menomonee Falls Wisconsin United States 53051
    102 Froedtert Hospital & the Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    103 Drexel Town Square Oak Creek Wisconsin United States 53154
    104 Aspirus Regional Cancer Center Wausau Wisconsin United States 54401
    105 Froedtert West Bend Hospital West Bend Wisconsin United States 53095
    106 Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids Wisconsin United States 54494
    107 CHU de Quebec - L'Hotel-Dieu de Quebec Québec City Quebec Canada G1R 2J6
    108 CIUSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke Canada J1H 5N4

    Sponsors and Collaborators

    • RTOG Foundation, Inc.
    • Pfizer
    • Astellas Pharma Inc

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    RTOG Foundation, Inc.
    ClinicalTrials.gov Identifier:
    NCT03809000
    Other Study ID Numbers:
    • RTOG 3506
    • STEEL
    First Posted:
    Jan 18, 2019
    Last Update Posted:
    Mar 18, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by RTOG Foundation, Inc.
    Post-prostatectomy
    Enzalutamide
    STEEL
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Leuprolide
    Goserelin
    Bicalutamide

    Study Results

    No Results Posted as of Mar 18, 2022