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Radiation Hypofractionation Via Extended Versus Accelerated Therapy (HEAT) For Prostate Cancer

NCT01794403 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2025-10-24

No results posted yet for this study

Summary

Accelerated Hypofractionation Radiotherapy for prostate cancer of 36.25 Gy delivered in 5 fractions will not be inferior to the standard treatment of 70.2 Gy given in 26 fractions with respect to four-year biochemical failure (PSA failure) by Phoenix definition post-treatment completion.

Conditions

Interventions

RADIATION

Extended Hypofractionation Radiotherapy

A total dose of 70.2 Gy will be delivered in 26 fractions, 2.7 Gy to the Planning Target Volume (PTV) by Intensity Modulated Radiotherapy (IMRT) with stationary gantry or rotating gantry technique.

RADIATION

Accelerated Hypofractionation Radiotherapy

A total dose of 36.25 Gy will be delivered in 5 fractions, 7.25 Gy each to the Planning Target Volume (PTV), by Stereotactic Body Radiotherapy (SBRT) techniques.

Sponsors & Collaborators

  • Jay L. Friedland MD Prostate Cancer Research Fund

    collaborator UNKNOWN

  • University of Miami

    lead OTHER

Principal Investigators

  • Matthew Abramowitz, MD · University of Miami

  • Alan Pollack, MD, PhD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-04
Primary Completion
2027-02-01
Completion
2027-02-01
FDA Device
Yes

Countries

  • United States
  • Australia
  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01794403 on ClinicalTrials.gov