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
University of Aarhus
400 participants
Mar 1, 2022
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria10
- 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
Exclusion Criteria7
- No previous treatment for prostate cancer
- Hip-prostheses
- Other metal devices in the pelvic region (except fiducials)
- Previous major abdominal/rectal surgery
- Any other malignancy the last five years except for basal or squamous cell skin cancer
- 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).
Interventions
Patients in the experimental arm will receive proton therapy within the same dose and fraction schedule as patients receiving photon therapy, which is standard treatment.
Patients in the photon arm will receive standard treatment with photon therapy.
Locations(7)
View Full Details on ClinicalTrials.gov
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NCT05350475