NCT05232578

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 380 (estimated)
• Sponsor: General University Hospital, Prague · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	Early salvage radiotherapy (eSRT)	eSRT administered immediately after the confirmation of the biochemical relapse (PSA ≈ 0.2ng/ml). 66-70Gy will be delivered to the bed of prostate. Radiotherapy will be optionally accompanied by androgen deprivation therapy.
RADIATION	Delayed Salvage radiotherapy (dSRT)	dSRT administered if PSA levels increase to ≥ 0.4 ng/ml. 66-70Gy will be delivered to the bed of prostate. Radiotherapy will be optionally accompanied by androgen deprivation therapy.

Timeline

• Start date: 2022-09-01
• Primary completion: 2032-12-01
• Completion: 2032-12-01
• First posted: 2022-02-10
• Last updated: 2022-08-03