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
> 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)
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
Parallel
Early salvage radiotherapy (eSRT)
RadiationeSRT 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.
Delayed Salvage radiotherapy (dSRT)
RadiationdSRT 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.
Event-free survival (EFS)
Defined as a time to re-documented biochemical relapse after salvage therapy (bRFS), demonstration of clinical relapse (i.e.,local relapse /lRFS/, locoregional relapse /lrRFS/, distant relapse /MFS/) and/or death from any cause.
Carcinoma-specific survival (CSS)
Overall survival (5y- and 10y- OS)
Incidence of treatment-related acute and late toxicity
Comparison of the incidence of treatment-related acute and late toxicity between patients after early/ delayed salvage therapy. Acute and late toxicity will be assessed and graded using Common Terminology Criteria for Adverse Events (CTCAE).
Health-related quality of life (QoL) assessment.
The analysis of the QoL of both study ARMs will be made based on EORTC validated questionnaires (QLQ-C30 and QLQ-PR25). QLQ-C30 was developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. The EORTC QLQ-PR25 is used in conjunction with the EORTC QLQ-C30 and provides information on an additional 25 items specifically related to prostate cancer.
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