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Prospective Study of Ultrahypofractionated Proton Beam Therapy for Localized Prostate Cancer

StatusRecruiting
PhaseNot applicable
Started
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Record History

  1. Minor Study First Submitted
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
(from sponsor)
Prostate Neoplasm
Related terms Prostatic Neoplasms
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov