At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 30 enrolled
Drug / intervention
radiotherapyradiation
Likely dose
Prostate: 70 Gy; pelvic lymph nodes: 56 Gy via intensity-modulated radiation therapyAI-extracted
Key inclusion· 3
- ✓Prostate cancer stage T1-T3
- ✓Predicted risk of lymph node involvement >15%
- ✓Gleason score >7
Key exclusion· 2
- ✕Distant metastases present
- ✕Currently on anticoagulant therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Prostate Cancer Trial Treating Pelvic Lymph Nodes to High Dose Using Intensity Modulated Radiation Therapy
In Brief
A Phase 2 clinical trial evaluating radiotherapy for Prostate Cancer. Completed, enrolled 30 participants across 1 site.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2005
First PostedSep 2005
Primary CompletionMar 2016
TodayJul 2026
First PostedSep 21, 2005
Enrollment StartMar 1, 2005
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 11 yearsPosted 20.8 years ago
Interventions
radiotherapyradiation
prostate radiation to 70Gy; nodal radiation to 56Gy