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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).

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05350475). StuddyBuddy aggregates publicly available trial information.