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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorRigshospitalet, Denmark

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

1,016 Participants
are divided into 4 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