Long-term Better Than Short-term ADT With Salvage RT
Condition(s) studied
Investigational drug(s) / intervention(s)
Triptoreline: Comparison of the duration of ADT (Triptoreline)
Study summary
A randomized, multicenter, prospective PHASE II trial to assess the effect of short- versus long-term adjuvant ADT with high dose salvage radiotherapy on distant metastasis free survival in case of biochemical relapse (BR) after radical prostatectomy.
Eligibility
Primary outcome measure(s)
- Metastasis-free survival — 5 years
Time to appearance of M1a-b-c disease. In order to assess the absence/presence of M1a-M1c disease as early as possible, top-of-the-line imaging will be conducted in case of BR during follow-up after SRT and after agreement of the multidisciplinary uro-oncology team. Time point zero is the last day of radiotherapy (also applies for secondary endpoints). Top of the line imaging includes: CT thorax abdomen and bone scintigraphy (standard). PSMA PET-CT is allowed but not obligatory. Patients who are also included in the diagnostic imaging study are required to receive a PSMA PET-CT. Whole body MRI is allowed but not obligatory. BR is defined as any rise in PSA above the level of 0.2 ng/ml after a postradiotherapy nadir or a continued rise in the serum PSA despite salvage treatment (3). In case a BR is not accompanied by metastatic progression, PSMA PET/CT will be repeated every 6 months or earlier in case of prostate cancer-related symptoms.
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| AZ Maria Middelares | Ghent | Belgium | Recruiting |
| UZ Gent | Ghent | Belgium | Recruiting |
| UZ Leuven | Leuven | Belgium | Recruiting |
More Universitaire Ziekenhuizen KU Leuven trials in Belgium
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04242017 on ClinicalTrials.gov ↗ ← All trials in Belgium