NCT07343349Recruiting
Addition of Focal Boost to Primary Radiotherapy for Prostate Cancer in 12 or 20 Fractions
Addition of Focal Boost to Primary Radiotherapy for Prostate Cancer in 12 or 20 Fractions: A Large DAPROCA Randomised Trial.
Source: ClinicalTrials.gov · Last updated 21 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1016 (estimated)
- First submitted
- 2 Dec 2025
- Start date
- 15 Dec 2025
- Primary completion date
- 30 Oct 2040
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Diseases
- Prostate cancer
- NCT number
- NCT07343349
What you commit to
- Study type: Interventional
- Planned participants: 1016
- From 15 Dec 2025 to the primary completion date, 30 Oct 2040
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous pelvic irradiation
Other illness
- History of chronic inflammatory bowel disease (CIBD)
Other
- WHO performance status ≥ 2
- If, for any patient related reason, an MRI cannot be performed
- T4
- International prostate symptom score (IPSS) ≧ 20
- If fiducial markers cannot be inserted
- TURP within 3 months from start of treatment
- If the patient is judged by the physician to be unable to adhere to trial activities
Who the study is looking for
- Patients with biopsy verified PCa with no distant metastases with either
- Intermediate- or high-risk PCa, defined as at least one of the following risk criteria:
- Clinical stage cT2c-T3b (UICC TNM 8th edition)
- Imaging stage, T3a or T3b
- ≥ Gleason score 4+3, (ISUP Grade groups 3,4 or 5)
- Regional lymph node metastases N1
- Age \> 18
- WHO 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aurhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Not yet recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
| Sygehus Lillebaelt Coordinator of this site? Confirm its status | Vejle | Denmark | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.