Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Neoplasm | Prostate Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ultrahypofractionated Proton Beam Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ultrahypofractionated proton beam therapy
- description
- Participants receive definitive ultrahypofractionated proton beam therapy (35-40 Gy\[RBE\] in 5 fractions) for localized prostate adenocarcinoma using image-guided proton therapy. Participants are prospectively followed for oncologic outcomes, treatment-related toxicity, and patient-reported quality of life.
- interventionNames
- Radiation: Ultrahypofractionated Proton Beam Therapy
Primary outcomes (1)
- measure
- Biochemical recurrence-free survival
- timeFrame
- Up to 5 years after completion of proton beam therapy
- description
- Biochemical recurrence is defined according to the Phoenix definition (PSA nadir + 2 ng/mL). Biochemical recurrence-free survival is measured from completion of proton beam therapy to biochemical recurrence or last follow-up.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 19 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available