Long-term results of short-course proton beam radiation for localized prostate cancer
Follows men with localized prostate cancer treated with 5 sessions of proton radiation.
Plain-language title generated from the registry record
Registry title: Prospective Study of Ultrahypofractionated Proton Beam Therapy for Localized Prostate Cancer
Key facts
- Where
- Goyang-si, South KoreaSee the site
Where in South Korea
- National Cancer Center - KoreaGoyang-si, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Cancer Center, Korea
- Trial code
- NCT07699705
- Record updated
- 13 July 2026
- Original description
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.Read full original descriptionShow less
Prospective Cohort Study for Identifying Factors Predicting Long-term Outcomes of Prostate Cancer Patients Who Received Ultrahypofractionated Proton Beam Therapy
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.
Inclusion: Histologically confirmed localized adenocarcinoma of the prostate; No evidence of distant metastasis (M0); Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; Eligible to receive definitive image-guided ultrahypofractionated pencil beam scanning proton beam therapy according to the study protocol; Ability to complete study questionnaires and comply with scheduled follow-up assessments; Provision of written informed consent before study enrollment.
Exclusion: Residual or recurrent prostate cancer following prior radical prostatectomy; Previous pelvic radiotherapy; Active malignancy within the previous 1 year, except adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or completely resected T1N0M0 malignancies; Evidence of distant metastatic disease; Uncontrolled psychiatric illness, severe traumatic brain injury, chronic alcohol or substance dependence, or other medical conditions that, in the investigator's judgment, would preclude safe participation or adequate follow-up; Inability or unwillingness to provide written informed consent or comply with study procedures.