Clinical Trials /

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

NCT03809000

Description:

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.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Trial to See What the Results Are for Radiation Therapy and Hormone Therapy vs Radiation Therapy With Enhanced Hormone Therapy With Enzalutamide for Patients With PSA Recurrence After Surgery
  • 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

Clinical Trial IDs

  • ORG STUDY ID: RTOG 3506
  • SECONDARY ID: STEEL
  • NCT ID: NCT03809000

Conditions

  • Prostate Cancer

Interventions

DrugSynonymsArms
EnzalutamideXtandi®Salvage Radiation Therapy + Enhanced ADT
BicalutamideCasodex®Salvage Radiation Therapy + Standard ADT
GnRH analogGonadotropin-releasing hormone analog, Lupron®, leuprolide acetate, goserelin acetate, Eligard™, Viadur™, Zoldaex®, Trelstar®Salvage Radiation Therapy + Standard ADT

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
Salvage Radiation Therapy + Standard ADTActive ComparatorSalvage RT will be given up to 66.60 Gy along with 24 months of a GnRH analog with or without 1-4 months of bicalutamide.
  • Bicalutamide
  • GnRH analog
Salvage Radiation Therapy + Enhanced ADTExperimentalSalvage RT will be given up to 66.60 Gy along with 24 months of a GnRH analog + 24 months of enzalutamide.
  • Enzalutamide
  • GnRH analog

Eligibility Criteria

        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 (≥ 0.7 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 ≥ 0.7
             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 109/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.

               -  Unstable angina and/or congestive heart failure requiring hospitalization within
                  the last 4 months prior to registration

               -  Seizure disorder or condition that may predispose to seizure (e.g. prior cortical
                  stroke or significant brain trauma)

               -  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.

          -  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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure: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.
Safety Issue:
Description:The time from the date of randomization to the date of progression, death from any cause or last known follow-up date.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:RTOG Foundation, Inc.

Trial Keywords

  • Post-prostatectomy
  • Enzalutamide
  • STEEL

Last Updated

December 5, 2019