Phase 2
Completed N=30
Intensity Modulated Radiation Therapy (IMRT) Radiotherapy for Treating Prostate Pelvic Nodes
Source: ClinicalTrials.gov NCT00214136 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcomePrimary: Number of Participants Experiencing Expected Toxicities — 13 Participants
Summary
The purpose of this study is to examine the clinical feasibility and efficacy of uing IMRT to escalate the biologically effective dose to the pelvic lymph nodes in a short course of radiation therapy. An increased total and biologically effective dose will be delivered to the pelvic lymph nodes (56 Gy at 2 Gy/fraction). The prostate will receive standard "short course" IMRT of radiation (70 Gy at 2.5 Gy/fraction).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Expected Toxicities |
13 | — |
| SECONDARY To Evaluate Local Tumor Control and Biochemical Progression-free and Metastasis-free Survival |
— | — |
Eligibility Criteria
Inclusion Criteria
- Prostate cancer stage T-T3
- Predicted risk of lymph node involvement > 15%
- Gleason > 7
Exclusion Criteria
- Distance metastases
- Use of anti-coagulant therapy
Data sourced from ClinicalTrials.gov (NCT00214136). 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.