Clinical trial · Interventional
Hypofractionated Proton Beam Therapy for Localized Prostate Cancer
Phase II Trial of Hypofractionated Proton Beam Therapy in Men With Localized Prostate Adenocarcinoma
NCT01950351CI-TRIAL-00114942active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This phase II trial studies the side effects and how well hypofractionated proton beam radiation therapy works in treating patients with prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Specialized radiation therapy, such as proton beam radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage II Prostate Adenocarcinoma AJCC v7 | Prostate Adenocarcinoma | CURATED_BROADER | 0.78 |
| Stage I Prostate Adenocarcinoma AJCC v7 | Prostate Adenocarcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Proton Beam Radiation Therapy | Radiation | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (proton beam radiation therapy)
- description
- Patients undergo proton beam radiation therapy in 15 fractions over 5-6 weeks.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Radiation: Proton Beam Radiation Therapy
- Other: Quality-of-Life Assessment
Primary outcomes (1)
- measure
- Cumulative incidence of late grade 2 or greater gastrointestinal (GI) toxicity
- timeFrame
- Up to 2 years post-treatment
- description
- The cumulative incidence of late grade 2 or greater GI toxicity will be estimated with a 95% confidence interval.
Secondary outcomes (5)
- measure
- Rates of acute toxicity
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of adenocarcinoma of the prostate within one year of study entry; evaluation can happen outside of MD Anderson as long as histological confirmation takes place at MD Anderson * History/physical examination with digital rectal examination of the prostate within 90 days prior to registration * Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material demonstrating Gleason score 2-7 within 365 days of registration * Clinical stage T1-2b (American Joint Committee on Cancer \[AJCC\] 7th edition) and PSA \< 20 ng/mL within 90 days prior to registration; PSA should not be obtained within 10 days after prostate biopsy * Zubrod performance status 0-1 within 90 days prior to registration * Patient must be able to provide study-specific informed consent prior to study entry * Willingness and ability to complete the EPIC questionnaire Exclusion Criteria: * Prior or concurrent invasive malignancy (except non-melanomatous skin cancer or lymphomatous/hematogenous malignancy) unless continually disease free for a minimum of 5 years * Evidence of distant metastases * Regional lymph node involvement * Previous prostatectomy, cryosurgery, or high intensity focused ultrasound (HIFU) for prostate cancer * Previous pelvic radiation or prostate brachytherapy * Active and severe medical co-morbidity defined as follows: unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months, transmural myocardial infarction within the last 6 months, acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration, chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration, hepatic insufficiency resulting in clinical jaundice, active inflammatory bowel disease (Crohn's disease or ulcerative colitis), diagnosed connective tissue disorder, or congenital coagulation defects (patients on medical therapy with Coumadin or other blood thinning agents are eligible for participation)
References
Publications (0)
Data not yet available
No reference posted for this study.