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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorGeneral University Hospital, Prague

About this trial

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

Eligibility criteria

Qualifiers

> 18 years of age

Pathologically confirmed invasive prostate carcinoma with minimal 1 risk factor (RF) after radical prostatectomy (RP)

Patient refuses the adjuvant therapy after normalization of urinary function within 6 month after RP

Signed informed consent to participate in the study and (where necessary) consent to participate in the translational part of the research (not a requirement)

Disqualifiers

Life expectancy (based on Charlson comorbidity index) < 10 years

Patient not fit for the therapy

History of other cancer (other than a radically removed non-melanoma skin carcinoma)

Previous pelvic irradiation

Trial design

Treatments tested in this trial

  • Early salvage radiotherapy (eSRT)
  • Delayed Salvage radiotherapy (dSRT)

Treatment groups

380 Participants
are divided into 2 treatment groups

Locations

This trial has no locations