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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01794403




Registration number
NCT01794403
Ethics application status
Date submitted
14/02/2013
Date registered
18/02/2013

Titles & IDs
Public title
Radiation Hypofractionation Via Extended Versus Accelerated Therapy (HEAT) for Prostate Cancer
Scientific title
A Randomized Study of Radiation Hypofractionation Via Extended Versus Accelerated Therapy (HEAT) for Prostate Cancer
Secondary ID [1] 0 0
NCI-2019-06935
Secondary ID [2] 0 0
20110491
Universal Trial Number (UTN)
Trial acronym
HEAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of participants achieving two-year failure.
Timepoint [1] 0 0
Up to 2 years
Secondary outcome [1] 0 0
Incidence of treatment related adverse events.
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Percentage of Participants achieving failure
Timepoint [2] 0 0
Up to 2 years
Secondary outcome [3] 0 0
Mortality Rate
Timepoint [3] 0 0
Up to 5.25 years
Secondary outcome [4] 0 0
Overall Survival
Timepoint [4] 0 0
Up to 5.25 years
Secondary outcome [5] 0 0
Percentage of participants achieving ASTRO-defined biochemical failure
Timepoint [5] 0 0
Up to 5.25 years
Secondary outcome [6] 0 0
HRQOL as assessed by MAX-PC questionnaire
Timepoint [6] 0 0
Up to 5.25 years
Secondary outcome [7] 0 0
HRQOL as assessed by EPIC-SF-12 questionnaire
Timepoint [7] 0 0
Up to 5.25 years
Secondary outcome [8] 0 0
Incidence of late-occurring treatment related adverse events
Timepoint [8] 0 0
Up to 5.25 years

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
Minimum age
35 Years
Maximum age
85 Years
Sex
Males
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/04/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2027
Actual
Sample size
Target
456
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Northern Sydney Local Health District - Royal North Shore Hospital - St. Leonards
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
Italy
State/province [2] 0 0
Turin

Funding & Sponsors
Primary sponsor type
Other
Name
University of Miami
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Jay L. Friedland MD Prostate Cancer Research Fund
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Matthew Abramowitz, MD
Address 0 0
University of Miami
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jacqueline Rodriguez Amado
Address 0 0
Country 0 0
Phone 0 0
305-243-5620
Fax 0 0
Email 0 0
jxr1572@med.miami.edu
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT01794403