Actively Recruiting
Addition of Focal Boost to Primary Radiotherapy for Prostate Cancer in 12 or 20 Fractions
Led by Rigshospitalet, Denmark · Updated on 2026-01-21
1016
Participants Needed
3
Research Sites
776 weeks
Total Duration
On this page
Sponsors
R
Rigshospitalet, Denmark
Lead Sponsor
S
Sygehus Lillebaelt
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Addition of Focal Boost to Primary Radiotherapy for Prostate Cancer in 12 or 20 Fractions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with biopsy verified prostate cancer without distant metastases
- Intermediate- or high-risk prostate cancer defined by at least one: clinical stage cT2c-T3b, imaging stage T3a or T3b, Gleason score 4+3 or higher (ISUP Grade groups 3,4 or 5), or regional lymph node metastases N1
- Age over 18 years
- WHO performance score 0-1
- Intraprostatic lesion visible on MRI
- Suitable for focal boost
- Ability to give written informed consent and willingness to return for follow-up
You will not qualify if you...
- WHO performance status 2 or higher
- Inability to have an MRI for any patient-related reason
- Clinical stage T4
- International prostate symptom score (IPSS) 20 or higher
- Inability to have fiducial markers inserted
- Transurethral resection of the prostate (TURP) within 3 months before treatment start
- Previous pelvic irradiation
- Physician judgment of inability to adhere to trial activities
- History of chronic inflammatory bowel disease (CIBD)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Aurhus University Hospital
Aarhus, Denmark, 8200
Not Yet Recruiting
2
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
3
Sygehus Lillebaelt
Vejle, Denmark, 7000
Not Yet Recruiting
Research Team
P
Peter Meidahl Petersen,, MD., PhD.
CONTACT
P
Peter M Petersern, MD., PhD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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