N/A
Completed N=12
Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer
Prostatic Neoplasm
Source: ClinicalTrials.gov NCT01540994 ↗
Enrolled (actual)
12
Serious AEs
16.7%
Results posted
Jan 2025
Primary outcomePrimary: Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. — 11; 0; 0; 0 participants
Summary
The purpose of this study is to evaluate a short course (five radiation treatments) of very focused ("stereotactic") external beam radiation therapy for the treatment of early stage prostate cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. |
11; 0; 0; 0; 1; 0 | — |
| SECONDARY Rate of Biochemical Disease-free Status |
10 | — |
Eligibility Criteria
Inclusion Criteria
- Male with any age (typically 50 to 70 years old) with a low risk disease. This is defined as a Gleason's score of 6 or less, clinical stage of T2a or less, and a PSA of less than 15. We will also include patients with Gleason's score of 3+4=7 if there are fewer than 2 cores positive, with no more than 5mm of tumor in aggregate dimension.
Exclusion Criteria
- Prior surgery or radiotherapy for prostate cancer, PSA over 10, Gleason scores 7, 8, 9, or 10 (except Gleason 7 as noted, above), or clinical stage T2b, T2c, T3, or T4.
Data sourced from ClinicalTrials.gov (NCT01540994). 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.