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Prostate CancerHEATNCT01794403

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

A study testing Extended Hypofractionation Radiotherapy and Accelerated Hypofractionation Radiotherapy in people with Prostate Cancer, run by University of Miami at 3 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 85 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Extended Hypofractionation Radiotherapy and Accelerated Hypofractionation Radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
161 participants
Where
3 sitesin 3 countries
Study dates
4 Apr 2013to 1 Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 85 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Clinical stage is based on digital rectal exam (DRE). Seminal vesicle invasion on MRI is not eligible. T1a should be permitted if subsequent peripheral zone biopsies show tumor.
  • Prostate volume: ≤ 80 cc.
  • Determined using: volume = π/6 x length x height x width.
  • Measured from CT or MRI ≤90 days prior to enrollment.
  • Zubrod performance status 0-1.
  • No prior total prostatectomy or cryotherapy of the prostate.
  • Prior suprapubic prostatectomy, transurethral resection and laser ablation are permitted.
  • No prior radiotherapy to the prostate or lower pelvis.
  • No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
  • No chemotherapy for a malignancy in the last 5 years.
  • No history of an invasive malignancy (other than this prostate cancer, or nonmetastatic basal or squamous skin cancers) in the last 5 years.
  • 4-6 months of androgen deprivation therapy (ADT) are allowed for intermediate risk patients. This must be declared prior to randomization. This may not have been started more than 2 months prior to randomization.
  • Patient must be able to have gold fiducial markers placed in the prostate (if on anticoagulants, must be cleared by a primary care physician or cardiologist), or if patient already has fiducial marker placed, they must be in accordance with the protocol specifications. 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. fourth dimensional (4D) transperitoneal ultrasound, onboard MRI guidance).
  • Ability to understand and the willingness to sign a written informed consent document.
  • Willingness to fill out quality of life/psychosocial forms.
  • Age >= 35 and =< 85 years.
  • International Prostate Symptom Index (IPSS) (AUA) score ≤12

Who cannot join

  • 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.
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  • 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.
  • Not willing to fill out quality of life/psychosocial questionnaires.
  • IPSS score > to 12.
  • Age < 35 and > 85 years.

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

United States1 site

  • University of Miami

    Miami, Florida, 33136

Other trials in United States

Australia1 site

  • Northern Sydney Local Health District - Royal North Shore Hospital

    St Leonards, New South Wales, 2065

Other trials in Australia

Italy1 site

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

    Turin, Turin

Other trials in Italy

About this study

Official title: A Randomized Study of Radiation Hypofractionation Via Extended Versus Accelerated Therapy (HEAT) For Prostate Cancer

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
Being tested
Extended Hypofractionation Radiotherapy, Accelerated Hypofractionation Radiotherapy
Keywords
Radiation Therapy, Hypofractionation Radiotherapy, Extended Hypofractionation Radiotherapy, Accelerated Hypofractionation Radiotherapy, AHRT, EHRT
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Extended Hypofractionation RadiotherapyRadiation

    Also called EHRT

    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.

  • Accelerated Hypofractionation RadiotherapyRadiation

    Also called AHRT

    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.

Study groups in NCT01794403
Study groupRoleWhat they receive
Extended Hypofractionation Radiotherapy (EHRT) GroupExperimentalParticipants in this group will receive the EHRT intervention over a period of 6 weeks.
Receives: Radiation: Extended Hypofractionation Radiotherapy
Accelerated Hypofractionation Radiotherapy (AHRT) GroupExperimentalParticipants in this group will receive the AHRT intervention over a period of 2 weeks.
Receives: Radiation: Accelerated Hypofractionation Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 4 years (After Completion of Intervention)

Secondary outcomes (11)

  1. Number of Participants Achieving Two-Year Failure.

    The number of participants achieving either biochemical or clinical failure or positive biopsy. 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. Clinical failure will be reported as any clinical evidence of local progression or recurrence. A positive biopsy will be concluded via histological evaluation.

    Measured: Up to 2 years (After Completion of Intervention)

  2. Number of Participants Experiencing Acute Treatment-Related Toxicity

    Acute treatment-related toxicity will be reported as the number of participants experiencing treatment-related grade 3 or higher gastrointestinal (GI) or genitourinary (GU) adverse events during treatment or within three (3) months after treatment completion. Toxicity will be assessed using the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

    Measured: Up to 5 months (After Completion of Intervention)

  3. Prostate Cancer Mortality Rate as Measured by Number of Deaths

    The prostate cancer mortality rate will be reported as the number of deaths related to prostate cancer among participants.

    Measured: Up to 5.25 years (After Completion of Intervention)

  4. Overall Survival

    Overall survival will be reported as the elapsed time in months from randomization to death from any cause. For surviving patients, follow-up will be censored at the date of last contact.

    Measured: Up to 5.25 years (After Completion of Intervention)

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

    The number of participants achieving American Society for Therapeutic Radiation and Oncology (ASTRO) Consensus Definition (ACD) of biochemical failure will be reported. ACD failure is defined as three consecutive rises in post-treatment PSA, measured at the specified follow-up intervals.

    Measured: Up to 5.25 years (After Completion of Intervention)

  6. HRQOL as Assessed by MAX-PC questionnaire

    Health-related quality of life (HRQOL) will be measured using the scores on the Modified 18-item Memorial Anxiety Scale for Prostate Cancer (MAX-PC) from pre-treatment to post-treatment. The scale consists of 18 items (e.g. "I thought about prostate cancer even though I didn't mean to.") scored on a scale from 0 ("not at all") to 3 ("often"). Total scores range from 0 to 54, with higher scores indicating higher levels of anxiety.

    Measured: Up to 5.25 years (After Completion of Intervention)

  7. HRQOL as Assessed by EPIC-Short Form-12 questionnaire

    Health-related Quality of Life (HRQOL) will be measured using the Expanded Prostate Cancer Index Composite and Medical Outcomes Study Short Form-12 (EPIC-Short Form-12) to evaluate patient function and satisfaction after prostate cancer treatment. The questionnaire has 5 subscales (Urinary Function, Urinary Symptoms, Bowel Habits, Sexual Function and Hormonal Function). Each subscale has a total score ranging from 0-100, with higher scores representing better HRQOL.

    Measured: Up to 5.25 years (After Completion of Intervention)

  8. Number of Participants Experiencing Late Treatment-Related Toxicity

    Late treatment-related toxicity will be reported as the number of participants experiencing treatment-related grade 2 or higher gastrointestinal (GI) or genitourinary (GU) adverse events occurring more than three months after treatment completion. Toxicity will be assessed using the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

    Measured: Up to 5.25 years (After Completion of Intervention)

  9. Percentage of Participants Achieving Efficacy

    Efficacy will be reported as the percentage of participants achieving biochemical or clinical failure between participants with low and early intermediate risk for prostate cancer. 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. Clinical failure will be reported as any clinical evidence of local progression or recurrence.

    Measured: Up to 2 years (After Completion of Intervention)

  10. Average Incremental Cost Utility Score as Measured by Quality Adjusted Life Years (QALYs)

    An average cost utility score per patient for each treatment arm (AHRT and EHRT) will be reported as the quality adjusted life years among participants for that treatment. Cost utility will be calculated via analysis of the costs of a given treatment and compared to the cost utility of competing treatment.

    Measured: Up to 5.25 years (After Completion of Intervention)

  11. Percentage of Participants with Residual Tumor Post-Treatment

    The percentage of participants with residual tumor on both arms will be reported. The investigators will obtain prostate tissue from participants via biopsy two years after completion of protocol tissue. Tissue will analyzed for the expression of prostate cancer biomarkers. The expression of biomarkers in the post-treatment biopsies will be compared to that in the pre-treatment prostate biopsies.

    Measured: 2.25 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2013 (estimated)
  2. Study start4 Apr 2013
  3. Primary completion1 Feb 2027 (estimated)
  4. Study completion1 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01794403
Sponsor's protocol ID
20110491
Other IDs
NCI-2019-06935
Acronym
HEAT
Status last verified
Oct 2026
First submitted
14 Feb 2013
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Extended Hypofractionation Radiotherapy and Accelerated Hypofractionation Radiotherapy in people with Prostate Cancer, run by University of Miami at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 32 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Australia, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Achieving Four-Year Biochemical Failure. (time frame: Up to 4 years (After Completion of Intervention)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01794403.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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