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 — ESTABLISH  

Prostate Cancer Clinical Trial

Official title: 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

Status Not yet recruiting

Clinical Trial 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

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Aggression
• Carcinoma
• Prostate Cancer
• Prostatic Neoplasms
• Recurrence

• NCT number: NCT05232578
• Study type: Interventional
• Source: General University Hospital, Prague
• Contact: Sona Argalacsova, MD, PhD
• Phone: +420224962219
• Email: sona.argalacsova@vfn.cz
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 2022
• Completion date: December 2032