RecruitingNot ApplicableNCT07343349

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.


Sponsor

Rigshospitalet, Denmark

Enrollment

1,016 participants

Start Date

Dec 15, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving a targeted radiation boost to the most active part of the prostate tumour (a "focal boost"), alongside standard prostate radiation therapy delivered in 12 or 20 sessions (hypofractionated radiotherapy), improves cancer control without causing more side effects. **You may be eligible if...** - You are 18 or older - You have confirmed prostate cancer with no distant spread - Your cancer is intermediate or high risk (e.g., Gleason 4+3 or higher, clinical stage T2c–T3b, or lymph node involvement) - Your tumour is visible on MRI and suitable for a focal boost - You have mild urinary symptoms (IPSS score below 20) **You may NOT be eligible if...** - You have had previous pelvic radiation - You had a TURP (prostate scraping surgery) within the last 3 months - You have chronic inflammatory bowel disease - You have severe urinary symptoms (IPSS ≥ 20) or T4 disease - An MRI cannot be performed for any reason Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONAddition of focal boost and hypofractionation

Addition of focal boost to primary radiotherapy for prostate cancer in 12 or 20 fractions


Locations(3)

Aurhus University Hospital

Aarhus, Denmark

Rigshospitalet

Copenhagen, Denmark

Sygehus Lillebaelt

Vejle, Denmark

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NCT07343349


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