NCT05746806

Trial of Ultrahypofractionated Focal Salvage Radiotherapy for Isolated Prostate Bed Recurrence After Radical Prostatectomy

A Single Arm Phase II Trial of Ultrahypofractionated Focal Salvage Radiotherapy for Isolated Prostate Bed Recurrence After Radical Prostatectomy

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: Male
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The main objective of the trial is to explore the efficacy and safety of combining short-term androgen deprivation therapy (ADT) over 6 months to focal ultrahypofractionated salvage radiotherapy (SRT) delivered in 5 fractions to the site of local recurrence within the prostate bed after radical prostatectomy where multiparametric magnetic resonance imaging (mpMRI) and prostate-specific membrane antigen (PSMA) PET/CT are used to precisely identify the local recurrence and compare it to previously published literature.

Conditions

• Recurrent Prostate Cancer

Interventions

Type	Name	Description
RADIATION	Ultrahypofractionated salvage radiotherapy to a local recurrence after radical prostatectomy	Ultrahypofractioned radiotherapy for patients with isolated local recurrence after radical prostatectomy in 5 fractions
DRUG	Androgen deprivation therapy	In combination to the radiotherapy a short term androgen deprivation drug for 6 months will be applied. The preferred drug concept used is: \- LHRH(Luteinizing hormone releasing hormone)-agonist with 3-month subcutaneous depot injection (e.g. Pamorelin® LA (Triptorelin) 11.25mg s.c.) in combination with nonsteroidal antiandrogen (e.g. Bicalutamide 50mg/day) as flare protection at least 5 days before and max. 15 days after first LHRH-injection Alternatively the following oral drug concept can be used, if the patient rejects injections: \- GnRH (gonadotropin-releasing hormone)-antagonist with tablet intake for 6 months (e.g. Orgovyx® Tablets 120mg; first day 360mg, after second day 120mg per day)

Timeline

• Start date: 2023-03-29
• Primary completion: 2027-11-30
• Completion: 2027-11-30
• First posted: 2023-02-28
• Last updated: 2025-12-31

Locations

5 sites across 1 country: Switzerland