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
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.
- 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.
Locations & Contacts
Name Not Available
Contact: Paige Lampe
Contact: Marcella West Aguilar
Trial Objectives and Outline
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 Phase & Type
RTOG Foundation, Inc.
Secondary IDs NCI-2019-06210, STEEL
Clinicaltrials.gov ID NCT03809000