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
102
Locations
2
Arms
125
Anticipated Duration (Months)
2.4
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 DiseaseIntervention/TreatmentPhase
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

ArmIntervention/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

    SiteCityStateCountryPostal Code
    1Arizona Center for Cancer Care - GilbertGilbertArizonaUnited States85297
    2Arizona Center for Cancer Care - PeoriaPeoriaArizonaUnited States85381
    3Arizona Center for Cancer Care - PhoenixPhoenixArizonaUnited States85027
    4Arizona Center for Cancer Care - Scottsdale EastScottsdaleArizonaUnited States85251
    5Arizona Center for Cancer Care - Scottsdale NorthScottsdaleArizonaUnited States85258
    6Arizona Center for Cancer Care - SurpriseSurpriseArizonaUnited States85374
    7Marin Cancer Care, Inc.GreenbraeCaliforniaUnited States94904
    8Marin Health Medical CenterGreenbraeCaliforniaUnited States94904
    9University of Southern CaliforniaLos AngelesCaliforniaUnited States90033
    10USC Medical Center - Los Angeles CountyLos AngelesCaliforniaUnited States90033
    11Cedars-Sinai Medical CenterLos AngelesCaliforniaUnited States90048
    12Roseville Radiation Oncology CenterRosevilleCaliforniaUnited States95661
    13Sutter Roseville Medical CenterRosevilleCaliforniaUnited States95661
    14Sutter Medical Center SacramentoSacramentoCaliforniaUnited States95816
    15University of California, San FranciscoSan FranciscoCaliforniaUnited States94158
    16Valley View Hospital Cancer CenterGlenwood SpringsColoradoUnited States81601
    17University of Florida Health Science CenterGainesvilleFloridaUnited States32608
    18Nancy N. & J.C. Lewis Cancer & Research PavilionSavannahGeorgiaUnited States31405
    19Rush University Medical CenterChicagoIllinoisUnited States60612
    20Decatur Memorial HospitalDecaturIllinoisUnited States62526
    21Crossroads Cancer CenterEffinghamIllinoisUnited States62401
    22Loyola University Medical CenterMaywoodIllinoisUnited States60153
    23University of Kansas Cancer CenterKansas CityKansasUnited States66160
    24Kansas University Cancer Center Overland ParkOverland ParkKansasUnited States66210
    25Kansas University Cancer Center WestwoodWestwoodKansasUnited States66205
    26East Jefferson General HospitalMetairieLouisianaUnited States70006
    27LSU Healthcare Network/Metairie Multi-Specialty ClinicMetairieLouisianaUnited States70006
    28Coastal Cancer Treatment Center - BathBathMaineUnited States04530
    29Waldo Count General Hospital - BelfastBelfastMaineUnited States04915
    30Maine Health/SMHC Cancer Care and Blood Disorders-BiddefordBiddefordMaineUnited States04005
    31Maine Health/Stephens Memorial - NorwayNorwayMaineUnited States04268
    32Maine Medical Center - Bramhall S PortlandPortlandMaineUnited States04102
    33Penobscot Bay Medical Center - RockportRockportMaineUnited States04856
    34Maine Health CC of York County - SanfordSanfordMaineUnited States04073
    35Maine Health/SMHCancer Care and Blood Disorders - SanfordSanfordMaineUnited States04073
    36Maine Medical Cancer Center - Scarborough CampusScarboroughMaineUnited States04074
    37Maine Medical Partners - South PortlandSouth PortlandMaineUnited States04106
    38McLaren Cancer Institute - BloomfieldBloomfieldMichiganUnited States48302
    3921st Century Oncology MHP - ClarkstonClarkstonMichiganUnited States48346
    40McLaren Cancer Institute - ClarkstonClarkstonMichiganUnited States48346
    41William Beaumont Hospital - DearbornDearbornMichiganUnited States48124
    42Wayne State/Karmanos Cancer InstituteDetroitMichiganUnited States48201
    4321st Century Oncology MHP - FarmingtonFarmington HillsMichiganUnited States48334
    44McLaren Cancer Institute - FlintFlintMichiganUnited States48532
    45Singh and Arora Hematology Oncology PCFlintMichiganUnited States48532
    46McLaren Cancer Institute - Greater LansingLansingMichiganUnited States48910
    47Mid-Michigan Physicians - LansingLansingMichiganUnited States48912
    48McLaren Cancer Institute - Lapeer RegionLapeerMichiganUnited States48446
    4921st Century Oncology MHP - MacombMacombMichiganUnited States48044
    5021st Century Oncology MHP - Madison HeightsMadison HeightsMichiganUnited States48071
    51McLaren Cancer Institute - MacombMount ClemensMichiganUnited States48043
    52McLaren Cancer Institute - Central MichiganMount PleasantMichiganUnited States48858
    53McLaren Cancer Institute - OwossoOwossoMichiganUnited States48867
    54McLaren Cancer Institute - Northern MichiganPetoskeyMichiganUnited States49770
    55McLaren Cancer Institute - Port HuronPort HuronMichiganUnited States48060
    56William Beaumont Hospital - Royal OakRoyal OakMichiganUnited States48073
    57William Beaumont Hospital - TroySterling HeightsMichiganUnited States48314
    5821st Century Oncology MHP - TroyTroyMichiganUnited States48098
    59Mercy HospitalCoon RapidsMinnesotaUnited States55433
    60Minnesota Oncology Hematology PA - MaplewoodMaplewoodMinnesotaUnited States55109
    61Coborn Cancer CenterSaint CloudMinnesotaUnited States56303
    62HealthPartners, Inc.Saint Louis ParkMinnesotaUnited States55416
    63Regions HospitalSaint PaulMinnesotaUnited States55101
    64Kansas University Cancer Center NorthKansas CityMissouriUnited States64154
    65Kansas University Cancer Center Lee's SummitLee's SummitMissouriUnited States64064
    66Washington University School of MedicineSaint LouisMissouriUnited States63110
    67Exeter HospitalExeterNew HampshireUnited States03833
    68Dartmouth Hitchcock Medical Center/Norris Cotton Cancer CenterLebanonNew HampshireUnited States03756
    69University Physicians at OneidaOneidaNew YorkUnited States13421
    70Upstate Cancer Center Radiation Oncology at OneidaOneidaNew YorkUnited States13421
    71University Physicians at OswegoOswegoNew YorkUnited States13126
    72Upstate Cancer Radiation Oncology at OswegoOswegoNew YorkUnited States13126
    73SUNY Upstate Medical UniversitySyracuseNew YorkUnited States13210
    74Upstate Cancer Center at Hill Radiation OncologySyracuseNew YorkUnited States13210
    75UNC Rex Cancer CenterRaleighNorth CarolinaUnited States27607
    76Rex Cancer Center of WakefieldRaleighNorth CarolinaUnited States27614
    77WellSpan Health - Ephrata Cancer CenterEphrataPennsylvaniaUnited States17522
    78WellSpan Health - Adams Cancer CenterGettysburgPennsylvaniaUnited States17325
    79Penn State Milton S. Hershey Medical CenterHersheyPennsylvaniaUnited States17033
    80WellSpan Health - Sechler Family Cancer CenterLebanonPennsylvaniaUnited States17402
    81University of Pittsburgh Medical Center - Shadyside HospitalPittsburghPennsylvaniaUnited States15232
    82WellSpan Health - York HospitalYorkPennsylvaniaUnited States17403
    83Gibbs Cancer Center - PelhamGreerSouth CarolinaUnited States29650
    84Spartanburg Medical CenterSpartanburgSouth CarolinaUnited States29303
    85UT Southwestern/Simmons Cancer Center - DallasDallasTexasUnited States75390
    86American Fork HospitalAmerican ForkUtahUnited States84003
    87Cedar City HospitalCedar CityUtahUnited States84721
    88Logan Regional Medical CenterLoganUtahUnited States84341
    89Intermountain Medical CenterMurrayUtahUnited States84107
    90Utah Valley Regional Medical CenterProvoUtahUnited States84604
    91Dixie Regional Medical CenterSaint GeorgeUtahUnited States84790
    92Dartmouth Hitchcock Medical Center/Norris Cancer Ctr. - St. JohnsburySaint JohnsburyVermontUnited States05819
    93Sentara Cancer Institute at Sentara CarePlex HospitalHamptonVirginiaUnited States23666
    94Sentara Norfolk General HospitalNorfolkVirginiaUnited States23507
    95Sentara Virginia Beach General HospitalVirginia BeachVirginiaUnited States23454
    96Aspirus Langlade HospitalAntigoWisconsinUnited States54409
    97University Cancer Center Johnson CreekJohnson CreekWisconsinUnited States53038
    98University of Wisconsin Hospital and ClinicsMadisonWisconsinUnited States53792
    99Aspirus Regional Cancer CenterWausauWisconsinUnited States54401
    100Aspirus Cancer Care - Wisconsin RapidsWisconsin RapidsWisconsinUnited States54494
    101CHU de Quebec - L'Hotel-Dieu de QuebecQuébec CityQuebecCanadaG1R 2J6
    102CIUSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke-FleurimontSherbrookeCanadaJ1H 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:
    Nov 18, 2021
    Last Verified:
    Nov 1, 2021
    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.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 18, 2021