RecruitingNot applicableMale onlyEN originalProstate cancerEarly / localized

Prospective Study of Ultrahypofractionated Proton Beam Therapy for Localized Prostate Cancer

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Potwierdzony histologicznie rak prostaty zlokalizowany na terenie gruczołu (bez przerzutów odleglejszych)
  • Ogólny stan zdrowia wystarczająco dobry do leczenia (ECOG 0-2)
  • Możliwość otrzymania radioterapii protonowej zgodnie z protokołem badania
  • Chęć i możliwość udzielenia pisemnej zgody na udział w badaniu
  • Możliwość wypełniania ankiet i regularnych wizyt kontrolnych

✗ Disqualifies

  • Rak prostaty nawracający po wcześniejszym usunięciu gruczołu lub radioterapii
  • Przerzuty raka do innych narządów
  • Inne nowotwory w ciągu ostatniego roku (z wyjątkiem łagodnych raków skóry)
  • Poważne problemy psychiatryczne, alkoholizm lub uzależnienia, które uniemożliwią bezpieczne uczestnictwo
  • Brak możliwości lub niechęć do udzielenia zgody na udział w badaniu

Simplified criteria — AI translation

Trial details

Minimum age
19 Years
Last updated (source)
July 13, 2026
Sex
Male only

Therapies / drugs in trial

Locations (1)

National Cancer Center, Korea

Goyang-si, South Korea

Trial contact

Hyuna Park Clinical Research Coordinator, BS

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/14/2026.

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