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

NCT01794403 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: 20110491NCI-2019-06935
• Study Type: interventional
• Target: 161
• Locations: 3 countries
• Sites: 3

Brief 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

Prostate Cancer

Keywords

Radiation Therapy; Hypofractionation Radiotherapy; Extended Hypofractionation Radiotherapy; Accelerated Hypofractionation Radiotherapy; AHRT; EHRT

Outcome Measures

Primary Outcomes (1)

• Number of Participants Achieving Four-Year Biochemical Failure.

  The number of participants achieving four-year biochemical failure between both treatment arms will be reported. Biochemical Failure will be evaluated using the Phoenix definition wherein failure occurs when the Prostate Specific Antigen (PSA) is ≥ 2 ng/ml more than the lowest PSA measurement before the current one.

  Up to 4 years (After Completion of Intervention)

Secondary Outcomes (11)

• Number of Participants Achieving Two-Year Failure.

  Up to 2 years (After Completion of Intervention)

• Number of Participants Experiencing Acute Treatment-Related Toxicity

  Up to 5 months (After Completion of Intervention)

• Prostate Cancer Mortality Rate as Measured by Number of Deaths

  Up to 5.25 years (After Completion of Intervention)

• Overall Survival

  Up to 5.25 years (After Completion of Intervention)

• Numbers of Participants Achieving ASTRO Consensus Definition (ACD) of Biochemical Failure

  Up to 5.25 years (After Completion of Intervention)

Study Arms (2)

Extended Hypofractionation Radiotherapy (EHRT) Group

EXPERIMENTAL

Participants in this group will receive the EHRT intervention over a period of 6 weeks.

Radiation: Extended Hypofractionation Radiotherapy

Accelerated Hypofractionation Radiotherapy (AHRT) Group

EXPERIMENTAL

Participants in this group will receive the AHRT intervention over a period of 2 weeks.

Radiation: Accelerated Hypofractionation Radiotherapy

Interventions

Extended Hypofractionation Radiotherapy RADIATION

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.

Also known as: EHRT

Extended Hypofractionation Radiotherapy (EHRT) Group

Accelerated Hypofractionation Radiotherapy RADIATION

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.

Also known as: AHRT

Accelerated Hypofractionation Radiotherapy (AHRT) Group

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven prostate adenocarcinoma.
• Gleason score 2-7 (reviewed by reference lab at UM).
• Biopsy within one year of date of enrollment.
• Clinical stage ≤ T2 based on DRE and/or ≤ T3a based on MRI (if done); N0-Nx; M0-Mx (AJCC 7th Edition)
• T-stage and N-stage determined by physical exam and available imaging studies (CT, and/or MRI of the pelvis; see section 4.5). For MRI, questionable extracapsular extension is permitted. To distinguish blood from tumor the ideal study would be to acquire T2, T1 noncontrast and T1 dynamic contrast enhanced sequence, although this is not required. A small amount of extracapsular extension is permitted, as long as it can be included in the clinical target volume (CTV) and the constraints are met.
• M-stage determined by physical exam, CT or MRI. Bone scan not required unless clinical findings suggest possible osseous metastases.
• Prostate-Specific Antigen (PSA) \< 20 ng/ml, obtained no greater than 3 months prior to enrollment.
• Patients belonging in one of the following risk groups:
• Low:
• Clinical stage\* T1-T2; Gleason ≤ 6, PSA ≤ 10 \& \<50% biopsy cores positive.
• Intermediate:
• Clinical stage T2b-T2c; Gleason ≤ 6, PSA ≤ 10 \& \<50% biopsy cores positive.
• Clinical stage T1-T2; Gleason ≤ 6, PSA ≤ 10 \& ≥50% biopsy cores positive.
• Clinical stage T1-T2; Gleason = 7, PSA ≤ 10 \& \<50% biopsy cores positive or T1-T2; Gleason ≤ 6 \& PSA \>10 and \< 20 \& \< 50% biopsy cores positive.
• MRI stage T3a with evidence of extraprostatic extension is allowed.

You may not qualify if:

• Does not have a diagnosis of prostate adenocarcinoma.
• Patient has clinical T3a or any evidence of T3b disease.
• Patient has stage N1 or M1 disease.
• Patients has a PSA of greater than 20 ng/ml, obtained no greater than 3 months prior to randomization.
• Patient does not meet any of the risk groups outlined in section 3.1.4.
• Prostate volume greater than 80 cc.
• Zubrod performance status 2 or greater.
• Prior total prostatectomy.
• Prior radiation therapy to the prostate or lower pelvis.
• Implanted hardware which limits treatment planning or delivery (determined by the investigator).
• Chemotherapy within the past 5 years.
• Diagnosis of an invasive malignancy within 5 years (other than current prostate cancer or non-metastatic basal or squamous skin cancers or non-metastatic curatively treated papillary thyroid carcinoma).
• The use of more than 2 months of androgen deprivation therapy (ADT) prior to randomization, or plans for ADT to be continued for greater than 6 months.
• Inability to have gold fiducial markers placed in the prostate, or fiducial markers already placed that are not in accordance with the protocol (Section 4.2.2). Note: If a method of intrafraction prostate tracking is available which does not require fiducial markers, this will be adequate for this trial (i.e. 4D transperitoneal ultrasound, onboard MRI guidance).
• Unwilling or inability to give informed consent.

Sponsors & Collaborators

• University of Miami: lead
• Jay L. Friedland MD Prostate Cancer Research Fund: collaborator

Study Sites (3)

University of Miami

Miami, Florida, 33136, United States

Location

Northern Sydney Local Health District - Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

A.O.U. Città della Salute e della Scienza di Torino - University Hospital Trust of Turin

Turin, Turin, Italy

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Matthew Abramowitz, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

• Alan Pollack, MD, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical

Study Record Dates

• First Submitted: February 14, 2013
• First Posted: February 18, 2013
• Study Start: April 4, 2013
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); IT (1); AU (1)