Targeted tumor boost and shortened radiation schedules for prostate cancer
Addition of Focal Boost to Primary Radiotherapy for Prostate Cancer in 12 or 20 Fractions: A Large DAPROCA Randomised Trial.
This trial tests whether giving a higher radiation dose to the tumor inside the prostate (a focal boost) and delivering treatment in 12 instead of 20 sessions helps men with intermediate- or high-risk prostate cancer have fewer relapses and need less hormonal therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1016 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Aarhus and 2 other locations) |
| Trial ID | NCT07343349 on ClinicalTrials.gov |
What this trial studies
DAPROCA 10 is a randomized, multicenter trial in Denmark that uses modern MRI and high-precision radiotherapy to test two changes to standard prostate radiotherapy: adding a focal boost to MRI-visible intraprostatic lesions, and treating with a hypofractionated schedule of 12 fractions versus the conventional 20. Participants are randomized in a 2x2 design so roughly half receive the focal boost and half do not, and roughly half receive 12 fractions and half 20, with a planned total enrollment of 1,016 men. High-quality image guidance and strict planning standards are required at all participating centers to ensure accurate boost delivery without increasing dose to surrounding tissues. Outcomes include cancer control, need for subsequent hormone therapy, prostate cancer mortality, and treatment-related toxicity with long-term follow-up.
Who should consider this trial
Good fit: Men over 18 with intermediate- or high-risk localized or locally advanced prostate cancer, an MRI-visible intraprostatic lesion, WHO performance status 0–1, and who are suitable for a focal boost and able to attend follow-up are ideal candidates.
Not a fit: Patients with distant metastases, T4 disease, WHO performance status ≥2, MRI-invisible tumors, prior pelvic irradiation, recent TURP, severe urinary symptoms (IPSS ≥20), or chronic inflammatory bowel disease are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could reduce cancer relapse and prostate-cancer deaths while shortening treatment time and potentially lowering the need for long-term hormone therapy.
How similar studies have performed: Previous randomized trials such as the FLAME focal-boost trial and image-guidance studies including MIRAGE have reported improved local control or reduced toxicity with focal boosting and more precise delivery, providing supportive evidence for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Previous pelvic irradiation * If the patient is judged by the physician to be unable to adhere to trial activities * History of chronic inflammatory bowel disease (CIBD)
Where this trial is running
Aarhus and 2 other locations
- Aurhus University Hospital — Aarhus, Denmark (Not_yet_recruiting)
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
- Sygehus Lillebaelt — Vejle, Denmark (Not_yet_recruiting)
Study contacts
- Study coordinator: Peter Meidahl Petersen,, MD., PhD.
- Email: peter.meidahl.petersen@regionh.dk
- Phone: +45 35450603
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.