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ACTIVE NOT RECRUITING
NCT05746806
NA

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

Sponsor: Insel Gruppe AG, University Hospital Bern

View on ClinicalTrials.gov

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.

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

Key Details

Gender

MALE

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2023-03-29

Completion Date

2027-11-30

Last Updated

2025-12-31

Healthy Volunteers

No

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)

Locations (5)

Universitätsspital Basel

Basel, Switzerland

Istituto Oncologico della Svizzera Italiana-Ente Ospedaliero Cantonale (IOSI-EOC)

Bellinzona, Switzerland

Inselgruppe AG, Inselspital

Bern, Switzerland

Kantonsspital Winterthur, Klinik für Radio-Onkologie

Winterthur, Switzerland

Universitätsspital Zürich, Klinik für Radio-Onkologie

Zurich, Switzerland