Clinical Trial

Early Salvage Therapy for Patients With Advanced Features for Biochemical Relapse After Radical Prostatectomy for Localized Prostate Carcinoma In Correlation With Supposed Molecular-genetic Parameters of Higher Aggressiveness

Study acronym: ESTABLISH
Not Yet Recruiting Phase 3
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Summary
The primary objective of the trial is to compare the impact and safety of delayed salvage therapy (dSRT, i.e., SRT initiated at PSA values of 0.4-0.5 ng/ml) to those of early salvage therapy (eSRT, i.e., at PSA levels of 0.2 ng/ml) in patients with biochemical relapse after radical prostatectomy. The secondary objective of the trial is to perform analysis of the subgroups of patients to determine which patients are most likely to benefit from dSRT Exploratory objective of the trial is to determine whether selected molecular genetic parameters (172 candidate genes and molecular alterations) and known clinical parameters can be used to identify potential predictors of worse prognosis in patients with known risk factors for relapse after radical prostatectomy, thereby augmenting and refining patient stratification, optimizing their therapy, and clarifying the proper timing of multimodal therapy
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2022-01-26; most recent amendment 2022-08-02.
Trial Details
NCT Number NCT05232578
Lead Sponsor General University Hospital, Prague
Conditions Prostate Cancer
Enrollment 380 participants
Start Date 2022-09
Primary Completion 2032-12 (estimated)
Study Completion 2032-12 (estimated)
Updated on ClinicalTrials.gov 2022-08-03