Addition of Focal Boost to Primary Radiotherapy for Prostate Cancer in 12 or 20 Fractions
Recruiting · NCT07343349 · Interventional (participants receive a specific treatment) · Lead sponsor: Rigshospitalet, Denmark
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
- 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 is running
3 locations listed.
- Aurhus University Hospital - Aarhus, Denmark
- Rigshospitalet - Copenhagen, Denmark
- Sygehus Lillebaelt - Vejle, Denmark