Targeted tumor boost and shortened radiation schedules for prostate cancer
Official title: Addition of Focal Boost to Primary Radiotherapy for Prostate Cancer in 12 or 20 Fractions: A Large DAPROCA Randomised Trial.
Run by Copenhagen University Hospital, Rigshospitalet · NCT07343349 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 1016 (estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Aarhus and 2 other locations) |
| Status | Recruiting |
| Started | December 15, 2025 |
| Main results expected | October 30, 2040 |
| Study ends | October 30, 2040 |
| Registry record updated | January 21, 2026 |
| Trial ID | NCT07343349 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Rigshospitalet
Copenhagen, Denmark Recruiting -
Aurhus University Hospital
Aarhus, Denmark Not yet 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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Improved robotic surgery for advanced prostate cancer
This study tests a new robotic surgery technique for advanced prostate cancer to see if it helps improve recovery and urinary control compared to standard methods.
-
Combining Pluvicto with radiation therapy for advanced prostate cancer
This study is testing if combining the drug Pluvicto with radiation therapy can help people with advanced prostate cancer reduce the chance of their cancer coming back while keeping their quality of life intact.
-
Genomic biomarker-guided therapy for advanced prostate cancer
This study is testing if personalized treatment based on genetic markers can help men with advanced prostate cancer before surgery.
-
Combining relugolix and enzalutamide for high-risk prostate cancer treatment
This study is testing if combining two medications, relugolix and enzalutamide, can help men with high-risk prostate cancer do better with their treatment and live longer.
-
Intense hormone therapy before surgery for advanced prostate cancer
This study is testing whether a stronger hormone treatment before surgery can help men with advanced prostate cancer do better than the usual hormone therapy.
-
Evaluating PF-07248144 for advanced solid tumors
This study is testing a new drug called PF-07248144 to see if it can safely help people with advanced solid tumors, like certain types of breast, prostate, and lung cancers.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.