Study Summary
This trial is testing a new way to give radiation therapy to patients with high-risk prostate cancer. The new method features hypofractionation and a simultaneous integrated boost to the magnetic resonance imaging (MRI) identified intraprostatic tumor (IPT).
Eligible Conditions
- Prostate Cancer
Treatment Effectiveness
Study Objectives
1 Primary · 6 Secondary · Reporting Duration: 60 months after the end of radiation therapy
Year 5
Assessment of local persistence or local recurrence
Disease
Cumulative rate of biochemical failure at 5 years after the end of treatment.
Rate of distant metastases five years after end of radiation therapy
Month 60
Cumulative rate of late toxicity observed between 90 days and 5 years after end of treatment.
Day 90
Cumulative rate of acute toxicity observed between day 1 of treatment and 90 days after treatment.
Year 5
Rate of change in sexual, bowel, and urinary function from baseline measurement to 5 years after end of treatment.
Trial Safety
Trial Design
2 Treatment Groups
HR-A (High-risk A)
1 of 2
HR-B (High-risk B)
1 of 2
Experimental Treatment
100 Total Participants · 2 Treatment Groups
Primary Treatment: HR-A · No Placebo Group · N/A
HR-A (High-risk A)
Radiation
Experimental Group · 1 Intervention: HR-A · Intervention Types: RadiationHR-B (High-risk B)
Radiation
Experimental Group · 1 Intervention: HR-B · Intervention Types: RadiationTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 60 months after the end of radiation therapy
Who is running the clinical trial?
University of FloridaLead Sponsor
1,261 Previous Clinical Trials
699,340 Total Patients Enrolled
10 Trials studying Prostate Cancer
3,818 Patients Enrolled for Prostate Cancer
Curtis M Bryant, MD, MPHPrincipal InvestigatorUniversity of Florida Health Proton Therapy Institute
1 Previous Clinical Trials
1 Trials studying Prostate Cancer
Eligibility Criteria
Age 18 - 100 · Male Participants · 11 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
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Frequently Asked Questions
Does this research project include elderly participants?
"This medical trial is inviting applicants aged 18 and up, but no older than 100 years old." - Anonymous Online Contributor
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