Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: prostate carcinoma
salvage therapy
biochemical relapse
Lead sponsor: General University Hospital, Prague
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 380
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A "balanced design" is used for the 1:1 randomization into two arms A and B:
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: Inclusion Criteria:

* \> 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)
* ECOG 0 - 1
* pT2 and minimal 1 risk factor (RF):

  * R1 (PSM), and/or
  * Gleason score (4+3=7) 8-10 and/or ISUP grade group 3-5
* pT3a /pT3b with or without one RF
* No evidence of suspicious pelvic lymph nodes by initial diagnostic: cN0 and/or pN0
* No evidence of suspicious distant metastases by initial diagnostic: M0
* Patient with decline of PSA level to undetectable PSA levels (\< 0,1 ng/ml) or around 0,2ng/ml and with another decreasing trends so that the PSA level decline within 12-24 weeks after RP to undetectable levels (\< 0,1 ng/ml) and with renewed increase of PSA \>0,2 ng/ml (BCR= biochemical relapse) without any clinical relapse on PSMA PET/CT
* No hormonal therapy prior and /or after the radical prostatectomy
* Patient suitable and fit for subsequent radiotherapy with high likelihood of good compliance to the follow-up

Exclusion Criteria:

* 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
* Active immunosuppressive medication
* History of hormone therapy prior to randomization
* cN1 and/or pN1 and M1
* PSA-persistence after RP (PSA 12-weeks after RP \> 0.1 ng/ml or no decreasing trend described in Inclusion criteria)

Primary outcomes:
measure: Event-free survival (EFS)
timeFrame: Analysed 3 years after randomisation of the last patient.
Secondary outcomes:
measure: Carcinoma-specific survival (CSS)
timeFrame: Analysed 5/10 years after randomization of the last patient.
measure: Overall survival (5y- and 10y- OS)
timeFrame: Analysed 5/10 years after randomization of the last patient.
measure: Incidence of treatment-related acute and late toxicity
timeFrame: Analysed 5 years after randomization of the last patient.
measure: Health-related quality of life (QoL) assessment.
timeFrame: Analysed 5 years after randomization of the last patient.
Other outcomes:
Locations:
Study officials:
References:
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