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

NCT05746806 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-12-31

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • University of Bern

    collaborator OTHER

  • Debiopharm International SA

    collaborator INDUSTRY

  • Werner und Hedy Berger-Janser - Stiftung

    collaborator UNKNOWN

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Mohamed MS Shelan, PD · Department of radiation oncology, Bern University Hospital, Inselspital, Berne, Switzerland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05746806 on ClinicalTrials.gov