At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed adenocarcinoma of the prostate
- ✓Stage ≤ T2b disease per 1997 AJCC classification
- ✓Gleason score ≤ 7
- ✓Predicted lymph node involvement ≤15% by nomograms, or histologically negative pelvic nodes
- ✕Prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
- ✕Prior radical surgery or cryosurgery for prostate cancer
- ✕Prior or concurrent cytotoxic chemotherapy
- ✕Other active cancers (except localized basal/squamous skin cancer unless disease-free ≥5 years)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I/II Trial Examining Dose-per-Fraction Escalation Using Intensity Modulated Radiation Therapy in the Treatment of Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating Radiotherapy for Prostate Cancer. Completed, enrolled 347 participants across 1 site.
Detailed Summary
The purpose of this study is to examine the clinical feasibility of using Intensity-modulated radiation therapy (IMRT) combined with daily pretreatment prostate localization to deliver increasingly hypofractionated treatment courses. Progressively larger fraction sizes will be delivered in a phase I design based on both acute and long-term tolerances to the treatment. The dose-per-fraction escalation design utilizes schemas that maintain an isoeffective dose for late effects, while predicting that tumor control will actually improve. The delivery of fewer, larger fractions of radiation, if proven effective and safe, would result in significant cost saving and more efficient use of resources. Phase II will commence with Maximum Tolerated Dose (MTD) finding with up to 200 additional patients being enrolled during this phase of the study.
Study Details
Timeline
Interventions
Daily radiation to prescribed dose