NCT05350475Active, not recruiting
Protons vs. Photons for High-risk Prostate Cancer
Lymph Node Radiation Therapy With Integrated Boost to Prostate for High-risk Prostate Cancer A Randomized Phase 3 Trial Comparing Photons vs. Protons
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Brief summary (registry, in English)
The purpose of this study is to assess late gastro-intestinal side-effects comparing proton therapy to photon therapy in high-risk prostate cancer patients receiving whole pelvic irradiation.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 102 (estimated)
- First submitted
- 16 Mar 2022
- Start date
- Mar 2022
- Primary completion date
- Dec 2028
- Lead sponsor
- University of Aarhus
- Diseases
- Prostate cancer
- NCT number
- NCT05350475
What you commit to
- Study type: Interventional
- Planned participants: 102
- From Mar 2022 to the primary completion date, Dec 2028
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- No previous treatment for prostate cancer
- Previous major abdominal/rectal surgery
Other illness
- Any other malignancy the last five years except for basal or squamous cell skin cancer
Other
- Hip-prostheses
- Other metal devices in the pelvic region (except fiducials)
- Unable to understand patient information or comply with treatment and safety instructions
- Unable to read and understand patient information due to cognitive disabilities or language (Danish).
Who the study is looking for
- Histologically verified localized/locally advanced prostate cancer T1-3bN0-1M0 (TNM 8th edition). A clinical T4 is allowed if it is because of invasion into the bladder neck.
- Adenocarcinoma (mixed histology allowed as long as the adenocarcinoma component comprise more than 50%)
- Indication for elective lymph node irradiation
- PSA \< 100 ng/mL
- Age ≥18 years
- Performance status 0-1
- Life expectancy ≥ 10 years
- Able to understand and comply with the treatment protocol
- No evidence of inflammatory bowel disease Ability to adhere to procedures for study and follow-up
- Signed informed consent to participate in the study
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dept. of Oncology, Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Unknown status |
| Department of Oncology, Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
| Dept. of Oncology, Rigshospitalet, Denmark Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| Department of Oncology, Copenhagen University Hospital Herlev Coordinator of this site? Confirm its status | Herlev | Denmark | Unknown status |
| Dept. of Oncology, Zealand University Hospital, Denmark Coordinator of this site? Confirm its status | Næstved | Denmark | Unknown status |
| Department of Oncology, Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Unknown status |
| Department of Oncology, Vejle Hospital, Denmark Coordinator of this site? Confirm its status | Vejle | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.