CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 25 enrolled
Drug / intervention
Lattice Extreme Ablative Dose Radiation Therapy +1 moreradiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01411319
NCT01411319N/ACompleted
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A Phase I Trial of MRI-Guided Lattice Extreme Ablative Dose Radiotherapy For Prostate Cancer

University of Miami·interventional·Posted Aug 8, 2011·Updated Jul 13, 2021

In Brief

A clinical study evaluating Lattice Extreme Ablative Dose Radiation Therapy and Standard IMRT for Prostate Cancer and Prostate Adenocarcinoma. Completed, enrolled 25 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer, Prostate Adenocarcinoma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 8, 2011
Enrollment StartDec 27, 2011
Primary CompletionDec 31, 2014
Study CompletionMar 2, 2020
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 14.9 years ago

Interventions

Lattice Extreme Ablative Dose Radiation Therapyradiation

12 - 14 Gy dose pipes in 1 fraction to the multiparametric MRI defined gross tumor volumes (GTV) on Day 1.

Standard IMRTradiation

76 Gy in 38 fractions (2 Gy daily) of Standard Intensity-modulated radiation therapy (IMRT) starting on Day 2 for 7.5 weeks.