Addition of Focal Boost to Primary Radiotherapy for Prostate Cancer in 12 or 20 Fractions

Every year, about 700 Danish men get radiotherapy for prostate cancer with a high-risk of later progression. The risk of relapse is about 40 % after 5 - 8 years, so we need better treatment for these patients in Denmark and globally. The aim is to reduce later cancer spreading, need of hormone treatments and prostate cancer death. DAPROCA 10 tests two possible improvements: If a higher dose (boost) to intra-prostatic tumor lesions improves cure rates. If the radiotherapy can be given with 12 treatment fractions instead of 20 without increased side-effects. In this randomised trial half the participants get a boost and the other half don't. Half the patients get 12 treatments, the other half 20. To answer these questions we must include1016 participants. The trial is feasible because the technological advances in imaging and radiotherapy enables us to define the tumors in the prostate and to deliver the boost to the tumors with high precision, without increased dose to the surrounding organs.

NCT Number	NCT07343349
Lead Sponsor	Rigshospitalet, Denmark Collaborators: Sygehus Lillebaelt, Odense University Hospital, Aalborg University Hospital, Copenhagen University Hospital at Herlev, Naestved Hospital, Aarhus University Hospital
Conditions	Prostate Cancer Patients Undergoing External Radiation and Seed Implantation, High Risk Localised Prostate Carcinoma, Locally Advanced Prostate Cancer, Unfavourable Intermediate Risk Prostate Cancer
Enrollment	1,016 participants
Start Date	2025-12-15
Primary Completion	2040-10-30 (estimated)
Study Completion	2040-10-30 (estimated)
Updated on ClinicalTrials.gov	2026-01-21