NCT05232578Not yet recruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 3 Aug 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 380 (estimated)
- First submitted
- 24 Nov 2021
- Start date
- Sept 2022
- Primary completion date
- Dec 2032
- Lead sponsor
- General University Hospital, Prague
- Diseases
- Prostate cancer
- NCT number
- NCT05232578
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 380
- From Sept 2022 to the primary completion date, Dec 2032
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient not fit for the therapy
- Previous pelvic irradiation
- Active immunosuppressive medication
- History of hormone therapy prior to randomization
Other illness
- History of other cancer (other than a radically removed non-melanoma skin carcinoma)
Age
- Life expectancy (based on Charlson comorbidity index) \< 10 years
Other
- 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)
Who the study is looking for
- \> 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.