Ultrahypofractionated Proton Therapy for Localized Prostate Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center observational cohort at the National Cancer Center in Korea enrolling about 50 adults with localized prostate cancer treated with ultrahypofractionated proton beam therapy (35–40 Gy[RBE] in 5 fractions). Participants will undergo standard clinical follow-up, PSA testing, and imaging to assess long-term biochemical recurrence-free survival, progression-free survival, overall survival, and treatment-related toxicity, as well as factors that may predict outcomes. The study emphasizes the potential radiobiological and dosimetric advantages of proton therapy, including reduced exposure to surrounding tissues. Results will help clarify long-term safety, effectiveness, and predictors of benefit for ultrahypofractionated PBT in this setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* Residual or recurrent prostate cancer following prior radical prostatectomy.
* Previous pelvic radiotherapy.
* Evidence of distant metastatic disease.
* 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.
* 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.

Where it's running

• National Cancer Center, Korea
  Goyang-si, Gyeonggi-do, South Korea Recruiting

Study contacts

• Study coordinator: Hyuna Park Clinical Research Coordinator, BS
• Email: 77313@ncc.re.kr
• Phone: 82-31-920-0491

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.