Clinical Trial

Prospective Study of Ultrahypofractionated Proton Beam Therapy for Localized Prostate Cancer

Recruiting
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Summary
The goal of this prospective observational cohort study is to evaluate the long-term efficacy and safety of ultrahypofractionated proton beam therapy in patients with localized prostate cancer and to identify clinical and treatment-related factors associated with oncologic outcomes and treatment-related toxicity. The main questions it aims to answer are: What are the long-term biochemical recurrence-free survival, clinical progression-free survival, overall survival, and acute and late treatment-related toxicity outcomes following ultrahypofractionated proton beam therapy? Which clinical characteristics, treatment planning parameters, and patient-reported outcomes are predictive of long-term oncologic outcomes and treatment-related toxicity? Participants will: Receive protocol-based ultrahypofractionated proton beam therapy (35-40 Gy\[RBE\] in 5 fractions). Undergo routine clinical evaluation, laboratory testing including prostate-specific antigen (PSA), and imaging studies according to the institutional follow-up schedule. Complete patient-reported outcome questionnaires (EPIC-CP and Visual Analog Scale \[VAS\]) before treatment and during follow-up. Be followed prospectively to assess biochemical recurrence, clinical progression, survival outcomes, and acute and late treatment-related toxicities.
Trial Details
NCT Number NCT07699705
Lead Sponsor National Cancer Center, Korea
Conditions Prostate Neoplasm
Enrollment 50 participants
Start Date 2024-11-04
Primary Completion 2034-12-31 (estimated)
Study Completion 2034-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-13