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

Launched by GENERAL UNIVERSITY HOSPITAL, PRAGUE · Jan 26, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating two different approaches to treating prostate cancer in men who have experienced a rise in PSA levels after surgery to remove the prostate (called radical prostatectomy). The trial aims to compare “delayed salvage therapy” (starting treatment when PSA levels are between 0.4-0.5 ng/ml) with “early salvage therapy” (starting treatment at a lower PSA level of 0.2 ng/ml). Researchers want to find out which approach is safer and more effective in preventing the cancer from returning.

To participate in this trial, men must be over 18 years old and have been diagnosed with prostate cancer that has at least one risk factor after surgery. This includes specific tumor characteristics and a rise in PSA levels indicating a biochemical relapse. Participants will undergo treatment and regular check-ups to monitor their health and the effectiveness of the therapy. The study is not yet recruiting participants, and those who join will help researchers understand how to better tailor treatments for prostate cancer based on individual risk factors.

Gender

MALE

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)