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Active Not Recruiting
NCT05350475
Protons vs. Photons for High-risk Prostate Cancer
Conditions: Prostate Cancer, Radiotherapy Side Effect
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 102
Sponsor: University of Aarhus
Location: Dept. of Oncology, Rigshospitalet, Denmark Copenhagen Capital Region
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 Criteria
Inclusion Criteria:
* 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 Criteria:
* 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).
Source: ClinicalTrials.gov (NCT05350475). StuddyBuddy aggregates publicly available trial information.