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

Active not recruiting 36 enrolled Insel Gruppe AG, University Hospital Bern Debiopharm International SA · collab University of Bern · collab Werner und Hedy Berger-Janser - Stiftung · collab

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2023-03-29
Primary completion: 2027-11-30
Completion: 2027-11-30

Publications

Mathier E, Althaus A, Zwahlen D, Lustenberger J, Zamboglou C, De Bari B, Aebersold DM, Guckenberger M, Zilli T, Shelan M. HypoFocal SRT Trial: Ultra-hypofractionated focal salvage radiotherapy for isolated prostate bed recurrence after radical prostatectomy; single-arm phase II study; clinical trial protocol. BMJ Open. 2024 Jan 30;14(1):e075846. doi: 10.1136/bmjopen-2023-075846.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bicalutamide	Other / unclassified	50 mg	—
Subject	Relugolix	Small molecule	120 mg	Oral
Subject	Triptorelin	Other / unclassified	11.25 mg	Subcutaneous

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

Summary

Timeline

Publications

Drugs

Indications