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Hormone Therapy
> 15% risk of + LN for Prostate Cancer (PR05 Trial)
N/A
Waitlist Available
Led By Nancy P Mendenhall, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months after the completion of radiation therapy
Awards & highlights
PR05 Trial Summary
This trial is testing a new cancer treatment that uses proton radiation and low-dose chemotherapy. Researchers want to see if it is effective and has any side effects.
Eligible Conditions
- Prostate Cancer
PR05 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months after the completion of radiation therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after the completion of radiation therapy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acute Grade 3 or Higher Treatment-related Toxicity Rate.
Secondary outcome measures
Collect and Analyze Quality of Life, Treatment-related Late Morbidity, Disease Control, and Survival Outcome Parameters.
Collect and Analyze Treatment, Biologic and Diagnostic Information That May Impact Quality of Life, Disease Control, Morbidity and/or Survival Outcomes.
PR05 Trial Design
2Treatment groups
Experimental Treatment
Group I: High-risk arm A (HR-A)Experimental Treatment1 Intervention
< 15% risk of + lymph nodes (LN)
Group II: HR-BExperimental Treatment1 Intervention
> 15% risk of + LN
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
< 15% risk of + LN
2009
N/A
~80
> 15% risk of + LN
2009
N/A
~80
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Who is running the clinical trial?
University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,619 Total Patients Enrolled
9 Trials studying Prostate Cancer
3,741 Patients Enrolled for Prostate Cancer
Nancy P Mendenhall, MDPrincipal InvestigatorUniversity of Florida Proton Therapy Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a heart attack or heart failure in the past.You have had a hip replacement surgery in the past.You have an active inflammatory bowel disease that affects your rectum, such as Crohn's disease or ulcerative colitis. If you have non-active diverticulitis or Crohn's disease that doesn't affect your rectum, you can still participate.You are currently taking Saw Palmetto or methotrexate and cannot stop using it while undergoing radiation treatment.
Research Study Groups:
This trial has the following groups:- Group 1: High-risk arm A (HR-A)
- Group 2: HR-B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies for enrolment in this trial?
"This clinical trial, which was uploaded to the database on December 1st 2009 and last updated on December 1st 2021, is not presently seeking participants. Nevertheless, there are currently 1321 other trials recruiting patients."
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