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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01794403
Registration number
NCT01794403
Ethics application status
Date submitted
14/02/2013
Date registered
18/02/2013
Date last updated
13/03/2024
Titles & IDs
Public title
Radiation Hypofractionation Via Extended Versus Accelerated Therapy (HEAT) For Prostate Cancer
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Scientific title
A Randomized Study of Radiation Hypofractionation Via Extended Versus Accelerated Therapy (HEAT) For Prostate Cancer
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Secondary ID [1]
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NCI-2019-06935
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Secondary ID [2]
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20110491
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Universal Trial Number (UTN)
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Trial acronym
HEAT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Extended Hypofractionation Radiotherapy
Treatment: Other - Accelerated Hypofractionation Radiotherapy
Experimental: Extended Hypofractionation Radiotherapy (EHRT) Group - Participants in this group will receive the EHRT intervention over a period of 6 weeks.
Experimental: Accelerated Hypofractionation Radiotherapy (AHRT) Group - Participants in this group will receive the AHRT intervention over a period of 2 weeks.
Treatment: Other: 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.
Treatment: Other: 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.
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of participants achieving two-year failure.
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Assessment method [1]
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Reported will be the percentage of participants achieving either a 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.
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Timepoint [1]
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Up to 2 years
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Secondary outcome [1]
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Incidence of treatment related adverse events.
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Assessment method [1]
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Toxicity will be reported as the incidence of treatment related grade 2 or higher gastrointestinal (GI) or genitourinary (GU) toxicity. 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.
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Timepoint [1]
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2 years
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Secondary outcome [2]
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Percentage of Participants achieving failure
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Assessment method [2]
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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.
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Timepoint [2]
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Up to 2 years
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Secondary outcome [3]
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Mortality Rate
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Assessment method [3]
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Rate of death from prostate cancer will be reported.
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Timepoint [3]
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Up to 5.25 years
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Secondary outcome [4]
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Overall Survival
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Assessment method [4]
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Overall survival will be reported as the elapsed time from randomization to death from any cause. For surviving patients, follow-up will be censored at the date of last contact.
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Timepoint [4]
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Up to 5.25 years
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Secondary outcome [5]
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Percentage of participants achieving ASTRO-defined biochemical failure
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Assessment method [5]
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American Society for Therapeutic Radiation and Oncology (ASTRO) Consensus Definition (ACD) failure is defined as three consecutive rises in post-treatment PSA, measured at the specified follow-up intervals.
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Timepoint [5]
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Up to 5.25 years
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Secondary outcome [6]
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HRQOL as assessed by MAX-PC questionnaire
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Assessment method [6]
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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.
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Timepoint [6]
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Up to 5.25 years
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Secondary outcome [7]
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HRQOL as assessed by EPIC-SF-12 questionnaire
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Assessment method [7]
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Health-related Quality of Life (HRQOL) will be measured using the Expanded Prostate Cancer Index Composite and Medical Outcomes Study SF-12 (EPIC SF-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.
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Timepoint [7]
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Up to 5.25 years
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Secondary outcome [8]
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Incidence of late-occurring treatment related adverse events
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Assessment method [8]
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Late occurring toxicity will be reported as the incidence of treatment related grade 2 or higher gastrointestinal (GI) or genitourinary (GU) toxicity 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.
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Timepoint [8]
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Up to 5.25 years
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Eligibility
Key inclusion criteria
1. Histologically proven prostate adenocarcinoma.
- Gleason score 2-7 (reviewed by reference lab at UM).
- Biopsy within one year of date of enrollment.
2. 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.
3. Prostate-Specific Antigen (PSA) < 20 ng/ml, obtained no greater than 3 months prior to
enrollment.
4. 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.
5. Prostate volume: = 80 cc.
- Determined using: volume = p/6 x length x height x width.
- Measured from CT or MRI =90 days prior to enrollment.
6. Zubrod performance status 0-1.
7. No prior total prostatectomy or cryotherapy of the prostate.
- Prior suprapubic prostatectomy, transurethral resection and laser ablation are
permitted.
8. No prior radiotherapy to the prostate or lower pelvis.
9. No implanted hardware or other material that would prohibit appropriate treatment
planning or treatment delivery, in the investigator's opinion.
10. No chemotherapy for a malignancy in the last 5 years.
11. No history of an invasive malignancy (other than this prostate cancer, or
nonmetastatic basal or squamous skin cancers) in the last 5 years.
12. 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.
13. 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 (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).
14. Ability to understand and the willingness to sign a written informed consent document.
15. Willingness to fill out quality of life/psychosocial forms.
16. Age >= 35 and =< 85 years.
17. IPSS (AUA) score =12
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Minimum age
35
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Maximum age
85
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Does not have a diagnosis of prostate adenocarcinoma.
2. Patient has clinical T3a or any evidence of T3b disease.
3. Patient has stage N1 or M1 disease.
4. Patients has a PSA of greater than 20 ng/ml, obtained no greater than 3 months prior
to randomization.
5. Patient does not meet any of the risk groups outlined in section 3.1.4.
6. Prostate volume greater than 80 cc.
7. Zubrod performance status 2 or greater.
8. Prior total prostatectomy.
9. Prior radiation therapy to the prostate or lower pelvis.
10. Implanted hardware which limits treatment planning or delivery (determined by the
investigator).
11. Chemotherapy within the past 5 years.
12. 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).
13. 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.
14. 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).
15. Unwilling or inability to give informed consent.
16. Not willing to fill out quality of life/psychosocial questionnaires.
17. IPSS score > to 12.
18. Age < 35 and > 85 years.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
4/04/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2024
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Actual
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Sample size
Target
456
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Northern Sydney Local Health District - Royal North Shore Hospital - St. Leonards
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Recruitment postcode(s) [1]
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2065 - St. Leonards
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Florida
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Country [2]
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Italy
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State/province [2]
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Turin
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Miami
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Jay L. Friedland MD Prostate Cancer Research Fund
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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 two-year failure defined as a positive biopsy two years post treatment
completion or earlier evidence of biochemical or clinical failure.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01794403
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Matthew Abramowitz, MD
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Address
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University of Miami
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Jacqueline Rodriguez Amado
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Address
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Country
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Phone
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305-243-5620
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01794403
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