NCT07343349 Addition of Focal Boost to Primary Radiotherapy for Prostate Cancer in 12 or 20 Fractions
| NCT ID | NCT07343349 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rigshospitalet, Denmark |
| Condition | Prostate Cancer Patients Undergoing External Radiation and Seed Implantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,016 participants |
| Start Date | 2025-12-15 |
| Primary Completion | 2040-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,016 participants in total. It began in 2025-12-15 with a primary completion date of 2040-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07343349 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer Patients Undergoing External Radiation and Seed Implantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07343349 currently recruiting?
Yes, NCT07343349 is actively recruiting participants. Contact the research team at peter.meidahl.petersen@regionh.dk for enrollment information.
Where is the NCT07343349 trial being conducted?
This trial is being conducted at Aarhus, Denmark, Copenhagen, Denmark, Vejle, Denmark.
Who is sponsoring the NCT07343349 clinical trial?
NCT07343349 is sponsored by Rigshospitalet, Denmark. The trial plans to enroll 1,016 participants.
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