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

Last updated: August 2, 2022
Sponsor: General University Hospital, Prague
Overall Status: Active - Not Recruiting

Phase

3

Condition

Prostate Cancer

Carcinoma

Anger

Treatment

N/A

Clinical Study ID

NCT05232578
ESTABLISH 2021 Trial v03.2021
  • Ages > 18
  • Male

Study 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

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 6month after RP
  • Signed informed consent to participate in the study and (where necessary) consent toparticipate 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 12-24weeks 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 goodcompliance to the follow-up

Exclusion

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 trenddescribed in Inclusion criteria)

Study Design

Total Participants: 380
Study Start date:
September 01, 2022
Estimated Completion Date:
December 31, 2032