MedTrace Logo

Addition of Focal Boost to Primary Radiotherapy for Prostate Cancer in 12 or 20 Fractions

NCT07343349 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1016

Last updated 2026-01-21

No results posted yet for this study

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.

Conditions

  • Prostate Cancer Patients Undergoing External Radiation and Seed Implantation
  • High Risk Localised Prostate Carcinoma
  • Locally Advanced Prostate Cancer
  • Unfavourable Intermediate Risk Prostate Cancer

Interventions

RADIATION

Addition of focal boost and hypofractionation

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

Sponsors & Collaborators

  • Sygehus Lillebaelt

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • Aalborg University Hospital

    collaborator OTHER

  • Copenhagen University Hospital at Herlev

    collaborator OTHER

  • Naestved Hospital

    collaborator OTHER

  • Aarhus University Hospital

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-15
Primary Completion
2040-10-30
Completion
2040-10-30

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07343349 on ClinicalTrials.gov