NCT01411319

MRI-Guided Lattice Extreme Ablative Dose Radiotherapy For Prostate Cancer

A Phase I Trial of MRI-Guided Lattice Extreme Ablative Dose Radiotherapy For Prostate Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: Male
• Age: 35 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The hypotheses of this study are: 1. Delivery of single fraction Lattice Extreme Ablative Dose (LEAD) radiotherapy (RT) to the dominant tumor lesion(s) in the prostate as identified by multiparametric functional Magnetic Resonance Imaging is safe and feasible when given prior to standard prostate radiotherapy. 2. Biomarker expression levels differ in the functional MRI identified suspicious tumor regions and unsuspicious tumor regions. The investigators hypothesize that a significant source of variation in biomarker levels is due to tumor heterogeneity and that it is molecular abnormalities in the dominant tumor areas that are angiogenic and determine outcome.

Conditions

• Prostate Cancer
• Prostate Adenocarcinoma

Interventions

Type	Name	Description
RADIATION	Lattice Extreme Ablative Dose Radiation Therapy	12 - 14 Gy dose pipes in 1 fraction to the multiparametric MRI defined gross tumor volumes (GTV) on Day 1.
RADIATION	Standard IMRT	76 Gy in 38 fractions (2 Gy daily) of Standard Intensity-modulated radiation therapy (IMRT) starting on Day 2 for 7.5 weeks.

Timeline

• Start date: 2011-12-27
• Primary completion: 2014-12-31
• Completion: 2020-03-02
• First posted: 2011-08-08
• Last updated: 2021-07-13
• Results posted: 2021-06-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study