A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Followi… (NCT03809000) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery
United States188 participantsStarted 2019-04-15
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Prostate-specific antigen (PSA) level (≥ 0.2 ng/mL) within 120 days prior to registration. Patients must have a PSA ≥ 0.2 ng/mL prior to starting ADT. For patients being followed by an ultrasensitive PSA assay, a serum PSA concentration of ≥ 0.10 ng/mL will be considered eligible.
* GnRH analog may be started no more than 42 days prior study entry.
* 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 American Joint Committee on Cancer (AJCC) v8.0 is eligible but a pT stage
≥ pT3b is considered aggressive)
* Locoregional node involvement at radical prostatectomy (RP) (pN1)
* Persistently elevated PSA post-RP nadir (PEPP) defined as PSA \> 0.1 ng/mL after radical prostatectomy
* PSA ≥ 0.7 ng/mL
* Serum albumin ≥ 3.0 g/dL within 90 days prior to registration
* Glomerular filtration rate (GFR) ≥35 mL/min estimated by Cockcroft-Gault or measured directly…
What they're measuring
1
Percentage of Participants Alive Without Progression (Progression-Free Survival)
Timeframe: From randomization to first failure or last known follow-up. Median follow-up time at the time of analysis was 33.1 months. The 1- and 2-year estimates are reported.