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)