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Trial of Ultrahypofractionated Focal Salvage Radiotherapy for Isolated Prostate Bed Recurrence After Radical Prostatectomy
Sponsor: Insel Gruppe AG, University Hospital Bern
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
Conditions
Interventions
Ultrahypofractionated salvage radiotherapy to a local recurrence after radical prostatectomy
Ultrahypofractioned radiotherapy for patients with isolated local recurrence after radical prostatectomy in 5 fractions
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