CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 18 enrolled
Drug / intervention
SIMRT +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/NCT01411332
NCT01411332N/ACompleted
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A Phase III Trial of Hypofractionated External Beam Image-Guided Highly Targeted Radiotherapy: The HEIGHT Trial

University of Miami·interventional·Posted Aug 8, 2011·Updated May 22, 2023

In Brief

A clinical study evaluating SIMRT and HTIMRT for Prostate Cancer and Prostate Adenocarcinoma. Completed, enrolled 18 participants across 1 site.

Detailed Summary

1. Delivery of directed hypofractionated targeted (HT) radiotherapy (RT) tumor boost to the dominant tumor lesion in the prostate as identified by multiparametric MRI will increase tumor eradication from the prostate. 2. Biomarker expression levels differ in the multiparametric MRI defined regions at high risk of harboring tumors that determine outcome. 3. 10-15% of men undergoing RT have Circulating DNA or tumor cells (CTC) that are related to an adverse treatment outcome. 4. Quality of life will not differ significantly between the treatment arms. 5. Prostate cancer-related anxiety will be reduced in the HTIMRT arm, because the patients will be aware that the dominant tumor will be targeted with higher radiation dose.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer, Prostate Adenocarcinoma
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 8, 2011
Enrollment StartOct 31, 2011
Primary CompletionJul 11, 2017
Study CompletionNov 22, 2021
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 14.9 years ago

Interventions

SIMRTradiation

A total dose of 80 Gy will be delivered in 40 fractions to the Clinical Target Volume (CTV).

HTIMRTradiation

Dose escalation to the Multiparametric MRI (MP-MRI) by dose painting at 2.35-2.40 Gy per fraction, while the rest of the Clinical Target Volume (CTV) receives 2.0 Gy a fraction to 76 Gy. The hypofractionated targeted (HT) boost region will receive an absolute dose of 89.3-91.2 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 95.5 Gy in 2.0 Gy fractions.