NCT07699705Recruiting
Prospective Study of Ultrahypofractionated Proton Beam Therapy for Localized Prostate Cancer
Prospective Cohort Study for Identifying Factors Predicting Long-term Outcomes of Prostate Cancer Patients Who Received Ultrahypofractionated Proton Beam Therapy
Source: ClinicalTrials.gov · Last updated 13 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 2 Jul 2026
- Start date
- 4 Nov 2024
- Primary completion date
- 31 Dec 2034
- Lead sponsor
- National Cancer Center, Korea
- Diseases
- Prostate cancer
- NCT number
- NCT07699705
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 4 Nov 2024 to the primary completion date, 31 Dec 2034
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Inability or unwillingness to provide written informed consent or comply with study procedures.
Who the study is looking for
- 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.
Age in the registry: 19 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Cancer Center - Korea Coordinator of this site? Confirm its status | Goyang-si | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.