Accelerated Hypofractionation Radiotherapy for Prostate Cancer

University of Miami, Miami, FL
Prostate CancerAccelerated Hypofractionation Radiotherapy - Radiation
Eligibility
35 - 85
Male
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Prostate Cancer

Treatment Effectiveness

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Up to 5.25 years

2 years
Therapeutic procedure
Up to 2 years
Percentage of Participants achieving failure
Percentage of participants achieving two-year failure.
Up to 5.25 years
HRQOL as assessed by EPIC-SF-12 questionnaire
HRQOL as assessed by MAX-PC questionnaire
Incidence of late-occurring treatment related adverse events
Mortality Rate
Overall Survival
Percentage of participants achieving ASTRO-defined biochemical failure

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Accelerated Hypofractionation Radiotherapy (AHRT) Group
1 of 2
Extended Hypofractionation Radiotherapy (EHRT) Group
1 of 2

Experimental Treatment

456 Total Participants · 2 Treatment Groups

Primary Treatment: Accelerated Hypofractionation Radiotherapy · No Placebo Group · N/A

Accelerated Hypofractionation Radiotherapy (AHRT) Group
Radiation
Experimental Group · 1 Intervention: Accelerated Hypofractionation Radiotherapy · Intervention Types: Radiation
Extended Hypofractionation Radiotherapy (EHRT) Group
Radiation
Experimental Group · 1 Intervention: Extended Hypofractionation Radiotherapy · Intervention Types: Radiation

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5.25 years

Who is running the clinical trial?

Jay L. Friedland MD Prostate Cancer Research FundUNKNOWN
University of MiamiLead Sponsor
818 Previous Clinical Trials
388,525 Total Patients Enrolled
15 Trials studying Prostate Cancer
3,395 Patients Enrolled for Prostate Cancer
Matthew Abramowitz, MDPrincipal Investigator - University of Miami
Anne Bates Leach Eye Hospital Bascom Palmer Eye Institute, Jackson North Medical Center, University of Miami
Temple University School Of Medicine (Medical School)
Fox Chase Cancer Center (Residency)
Alan Pollack, MD, PhDPrincipal InvestigatorUniversity of Miami
5 Previous Clinical Trials
2,144 Total Patients Enrolled
5 Trials studying Prostate Cancer
2,144 Patients Enrolled for Prostate Cancer

Eligibility Criteria

Age 35 - 85 · Male Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You haven't had any other type of cancer, except for prostate cancer or non-invasive skin cancers, in the past 5 years.
You need to have small metal markers placed in your prostate, but if you are taking blood thinners, your doctor needs to approve it. If you already have markers, they need to be in the right place according to the study guidelines. If there's another method to track your prostate during treatment, it may be used instead.

Frequently Asked Questions

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](https://www.withpower.com/clinical-trials/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" - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.