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

NARecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

March 29, 2023

Primary Completion Date

September 30, 2025

Study Completion Date

August 31, 2027

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)"

Trial Locations (5)

3010

RECRUITING

Inselgruppe AG, Inselspital, Bern

4031

RECRUITING

Universitätsspital Basel, Basel

6500

RECRUITING

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

8091

RECRUITING

Universitätsspital Zürich, Klinik für Radio-Onkologie, Zurich

8401

RECRUITING

Kantonsspital Winterthur, Klinik für Radio-Onkologie, Winterthur

Sponsors
All Listed Sponsors
collaborator

University of Bern

OTHER

collaborator

Debiopharm International SA

INDUSTRY

collaborator

Werner und Hedy Berger-Janser - Stiftung

UNKNOWN

lead

Insel Gruppe AG, University Hospital Bern

OTHER