Ultra-hypofractionated radiation therapy for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Michigan Rogel Cancer Center, Ann Arbor, MIProstate CancerUltra-hypofractionated radiation therapy - Radiation
Eligibility
18+
Male
What conditions do you have?
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Study Summary

This trial will compare the quality of life of prostate cancer patients treated with two different types of radiation therapy.

Eligible Conditions
  • Prostate Cancer

Treatment Effectiveness

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: up to 5 years

2-years post-treatment
Change in patient reported GI and GU quality of life (QOL) at 2-years post-treatment from baseline
60 months post-treatment
Patient reported GI quality of life (QOL) up to 60 months
Patient reported GU quality of life (QOL) up to 60 months
Year 5
Treatment related toxicity - late
up to 5 years
Local failure, Regional failure, Distant metastases
Overall survival
Prostate cancer specific survival
Rate of biochemical failure
Time to progression
Day 90
Treatment related toxicity - acute

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Moderately Hypo-fractionated Radiation Therapy
1 of 2
Ultra-Hypofractionated Radiation Therapy
1 of 2

Active Control

Experimental Treatment

136 Total Participants · 2 Treatment Groups

Primary Treatment: Ultra-hypofractionated radiation therapy · No Placebo Group · Phase 2

Ultra-Hypofractionated Radiation Therapy
Radiation
Experimental Group · 1 Intervention: Ultra-hypofractionated radiation therapy · Intervention Types: Radiation
Moderately Hypo-fractionated Radiation Therapy
Radiation
ActiveComparator Group · 1 Intervention: Moderately Hypo-fractionated Radiation Therapy · Intervention Types: Radiation

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor
270 Previous Clinical Trials
18,019 Total Patients Enrolled
27 Trials studying Prostate Cancer
2,829 Patients Enrolled for Prostate Cancer
William Jackson, M.D.Principal InvestigatorUniversity of Michigan Rogel Cancer Center
1 Previous Clinical Trials
100 Total Patients Enrolled
1 Trials studying Prostate Cancer
100 Patients Enrolled for Prostate Cancer

Eligibility Criteria

Age 18+ · Male Participants · 7 Total Inclusion Criteria

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Frequently Asked Questions

What is the greatest number of participants allowed in this clinical research protocol?

"Affirmative. Details available on clinicaltrials.gov report that this medical experiment, first advertised on November 12th 2021, is currently enrolling participants from 1 trial site with a target of 136 patients in total." - Anonymous Online Contributor

Unverified Answer

Has Ultra-hypofractionated radiation therapy been given the stamp of approval by the FDA?

"Ultra-hypofractionated radiation therapy is considered moderately safe according to our team at Power, scoring a 2. This evaluation was reached due to the existence of some data on safety but no evidence regarding efficacy in this phase 2 trial." - Anonymous Online Contributor

Unverified Answer

Are recruitment efforts ongoing for this research endeavor?

"According to the details provided on clinicaltrials.gov, this study is accepting candidates and was initially posted November 12th 2021 with a recent amendment from December 16th 2021." - 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.