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Radiation Therapy

Hypofractionated Radiotherapy for Prostate Cancer (HEAT Trial)

N/A
Recruiting
Led By Alan Pollack, MD, PhD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically proven prostate adenocarcinoma
Gleason score 2-7 (reviewed by reference lab at UM)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5.25 years
Awards & highlights

HEAT Trial Summary

This trial will compare a new, more intensive treatment for prostate cancer to the standard treatment. The new treatment will be given in fewer, but larger doses, over a shorter period of time.

Who is the study for?
Men aged 35-85 with prostate cancer, Gleason score 2-7, and PSA <20 ng/ml can join this trial. They must have a prostate size ≤80 cc, no prior major prostate treatments or pelvic radiation, and no chemotherapy for any cancer in the last 5 years. Men with low to intermediate risk of cancer spread based on specific clinical criteria are eligible.Check my eligibility
What is being tested?
The trial is testing two different radiotherapy schedules for treating prostate cancer: one delivers a total dose of radiation over fewer sessions (accelerated) while the other spreads it out over more sessions (extended). The goal is to see if the accelerated method is as effective as the standard extended treatment after two years.See study design
What are the potential side effects?
Potential side effects from both types of radiotherapy may include skin irritation in treated areas, fatigue, urinary issues like increased frequency or discomfort, bowel changes such as diarrhea or rectal bleeding, and erectile dysfunction.

HEAT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer was confirmed through a tissue examination.
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My prostate cancer has a low to medium grade.
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I can have gold markers placed in my prostate.
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I am between 35 and 85 years old.
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My cancer is in an early stage and has not spread to distant parts of my body.
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My prostate is 80 cc or smaller.
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I can carry out all my usual activities without help.
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I have not had my prostate completely removed or frozen.

HEAT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5.25 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5.25 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of participants achieving two-year failure.
Secondary outcome measures
HRQOL as assessed by EPIC-SF-12 questionnaire
HRQOL as assessed by MAX-PC questionnaire
Incidence of late-occurring treatment related adverse events
+5 more

HEAT Trial Design

2Treatment groups
Experimental Treatment
Group I: Extended Hypofractionation Radiotherapy (EHRT) GroupExperimental Treatment1 Intervention
Participants in this group will receive the EHRT intervention over a period of 6 weeks.
Group II: Accelerated Hypofractionation Radiotherapy (AHRT) GroupExperimental Treatment1 Intervention
Participants in this group will receive the AHRT intervention over a period of 2 weeks.

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
899 Previous Clinical Trials
409,276 Total Patients Enrolled
16 Trials studying Prostate Cancer
3,431 Patients Enrolled for Prostate Cancer
Jay L. Friedland MD Prostate Cancer Research FundUNKNOWN
Alan Pollack, MD, PhDPrincipal InvestigatorUniversity of Miami
5 Previous Clinical Trials
2,143 Total Patients Enrolled
5 Trials studying Prostate Cancer
2,143 Patients Enrolled for Prostate Cancer

Media Library

Accelerated Hypofractionation Radiotherapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01794403 — N/A
Prostate Cancer Research Study Groups: Accelerated Hypofractionation Radiotherapy (AHRT) Group, Extended Hypofractionation Radiotherapy (EHRT) Group
Prostate Cancer Clinical Trial 2023: Accelerated Hypofractionation Radiotherapy Highlights & Side Effects. Trial Name: NCT01794403 — N/A
Accelerated Hypofractionation Radiotherapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01794403 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the basic requirements to take part in this clinical trial?

"This clinical trial is looking for 456 participants that are between 35 and 85 years old and have prostate cancer. Other inclusion criteria are as follows: must have a Gleason score of ≤ 6, a PSA level of ≤ 10, and < 50% positive biopsy cores; must have a Prostate-Specific Antigen (PSA) level < 20 ng/ml that was obtained no more than 3 months prior to enrollment; must have histologically proven prostate adenocarcinoma; must have a Gleason score of 2-7 that has been reviewed by the reference lab at UM; must have had a biopsy within"

Answered by AI

Are patients still being accepted into the trial program?

"That is correct. The listed information on clinicaltrials.gov affirms that this research is actively seeking participants. This trial was first posted on April 4th, 2013 and was most recently updated on December 1st, 2021. 456 individuals are needed to be enrolled from a single site."

Answered by AI

Could you please share how many people are currently enrolled in this research?

"The clinical trial is actively recruiting patients, as noted on clinicaltrials.gov. The original posting date was April 4th, 2013, and the most recent update was December 1st, 2021. They are looking for 456 patients from 1 location."

Answered by AI

Does this research include patients that are above the age of 50?

"The age bracket for this particular trial is 35 to 85. There are 77 clinical trials for people who are under 18 and 1344 for people who are over 65."

Answered by AI
~10 spots leftby Aug 2024