N/A
Completed N=167
Study of Hypofractionated Proton Beam Radiation Therapy for Prostate Cancer
Source: ClinicalTrials.gov NCT00831623 ↗Enrolled (actual)
167
Serious AEs
0.7%
Results posted
Mar 2023
Primary outcomePrimary: Number of Participants With Late Treatment-Related Toxicity Greater Than or Equal to Grade 3, CTCAE Version 4.0 — 1 Participants
Summary
The purpose of this study is to determine hypofractionated conformal proton beam radiation therapy of prostate cancer can achieve similar treatment benefits as our current institutional standard with conventional fractionation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Late Treatment-Related Toxicity Greater Than or Equal to Grade 3, CTCAE Version 4.0 |
1 | — |
| SECONDARY Number of Participants With Acute and Late Gastrointestinal or Genitourinary Grade 2 Morbidity, CTCAE Version 4.0 |
21 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed adenocarcinoma within 180 days of registration
- History & Physical Exam, including digital rectal exam (DRE), within 8 wks prior to registration
- Histologic evaluation of prostate biopsies at LLUMC, with Gleason score assignment
- Clinical stage, Tumor Stage (T1-T2C)
- Prostatic Specific Antigen (PSA) less than 10 ng.ml within 180 days prior to registration
Exclusion Criteria
- Prior or concurrent invasive malignancy
- Evidence of distant metastasis
Data sourced from ClinicalTrials.gov (NCT00831623). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.