About this trial
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.
Eligibility criteria
Qualifiers
Patients with biopsy verified PCa with no distant metastases with either
Clinical stage cT2c-T3b (UICC TNM 8th edition)
Imaging stage, T3a or T3b
≥ Gleason score 4+3, (ISUP Grade groups 3,4 or 5)
Disqualifiers
WHO performance status ≥ 2
If, for any patient related reason, an MRI cannot be performed
T4
International prostate symptom score (IPSS) ≧ 20
Trial design
Treatments tested in this trial
- Addition of focal boost and hypofractionation
Treatment groups
Sponsors and collaborators
Rigshospitalet, Denmark
Lead sponsor
Sygehus Lillebaelt
Collaborator
Odense University Hospital
Collaborator
Aalborg University Hospital
Collaborator
Copenhagen University Hospital at Herlev
Collaborator
Naestved Hospital
Collaborator
Aarhus University Hospital
Collaborator