Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
General University Hospital, Prague
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
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....
Eligibility Criteria
Inclusion
- \> 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
- 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)
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2032
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT05232578
Start Date
September 1 2022
End Date
December 1 2032
Last Update
August 3 2022
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.