A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery
NCT03809000
ABOUT THIS STUDY
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- 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.
- 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.
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Descriptive Information | |||||||
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Brief Title ICMJE | A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery | ||||||
Official Title ICMJE | 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 | ||||||
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. | ||||||
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 ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||
Condition ICMJE | Prostate Cancer | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE | 242 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | September 15, 2029 | ||||||
Estimated Primary Completion Date | September 15, 2024 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Canada, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03809000 | ||||||
Other Study ID Numbers ICMJE | RTOG 3506 STEEL ( Other Identifier: RTOG Foundation ) | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | RTOG Foundation, Inc. | ||||||
Study Sponsor ICMJE | RTOG Foundation, Inc. | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | RTOG Foundation, Inc. | ||||||
Verification Date | January 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |