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Proton Beam Therapy
Proton Radiation Therapy for Prostate Cancer (PR11 Trial)
N/A
Recruiting
Led By Curtis M Bryant, MD, MPH
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must be at least 18 years at the time of consent
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months after the end of radiation therapy
Awards & highlights
PR11 Trial 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).
Who is the study for?
Men over 18 with high-risk prostate cancer, who haven't had previous local treatments or pelvic radiation. They must have a visible tumor on MRI, no distant metastasis or positive lymph nodes, and be able to start treatment within 16 weeks of signing up. Participants should not have severe heart failure, end stage renal disease, inflammatory bowel diseases affecting the rectum, or recent major intrapelvic surgery.Check my eligibility
What is being tested?
The trial is testing if dose-escalated proton radiation therapy can better treat high-risk prostate cancer. It involves hypofractionation and an integrated boost targeting the tumor identified by MRI over 8-9 weeks. Androgen deprivation therapy may also be used for 18 months.See study design
What are the potential side effects?
Potential side effects include skin reactions in treated areas, fatigue, urinary issues like increased frequency or discomfort during urination, bowel changes such as diarrhea or rectal bleeding, and erectile dysfunction.
PR11 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
PR11 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years after the end of radiation therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years after the end 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
Cumulative rate of biochemical failure at 5 years after the end of treatment.
Secondary outcome measures
Assessment of local persistence or local recurrence
Disease
Cumulative rate of acute toxicity observed between day 1 of treatment and 90 days after treatment.
+3 morePR11 Trial Design
2Treatment groups
Experimental Treatment
Group I: HR-B (High-risk B)Experimental Treatment1 Intervention
Prostate, proximal seminal vesicles, and pelvic nodes: 2 cobalt gray equivalent per fraction to a total does of 46 cobalt gray equivalent.
Prostate and proximal seminal vesicles: 2 cobalt gray equivalent per fraction to a total dose of 32 cobalt gray equivalent.
Entire uninvolved seminal vesicle when part of the seminal vesicle is involved with tumor: 2 cobalt gray equivalent per fraction to a total dose of 78 cobalt gray equivalent.
Simultaneous integrated boost to the IPT: 2.2 cobalt gray equivalent per fraction to a total dose of 85.8 cobalt gray equivalent.
Group II: HR-A (High-risk A)Experimental Treatment1 Intervention
Prostate and proximal seminal vesicles: 2 cobalt gray equivalent per fraction to a total dose of 78 cobalt gray equivalent.
Simultaneous integrated boost to the IPT: 2.2 cobalt gray equivalent per fraction to a total dose of 85.8 cobalt gray equivalent.
Find a Location
Who is running the clinical trial?
University of FloridaLead Sponsor
1,341 Previous Clinical Trials
715,587 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been mostly active and able to carry out all pre-disease activities without restriction in the last 4 months.My prostate size changed by more than 25% since my last MRI, and I need another MRI.I have an active inflammatory bowel condition affecting my rectum.I have had both of my hips replaced.I have had surgery in the pelvic area, including on my bladder or prostate.I am currently on blood thinners.My prostate cancer is high-risk due to its stage, Gleason score, or PSA levels.My prostate cancer is at an early to mid-stage, confirmed by a biopsy in the last year.I haven't had a heart attack in the last 6 months, severe heart failure, or kidney failure.My prostate cancer is advanced and has been confirmed by imaging or physical exam.My prostate's inner part takes up more than 75% of its total volume on a CT scan.I had an MRI of my prostate on a high-quality machine within the last 6 months.I may have had a biopsy for prostate cancer, but it's not mandatory.I am 18 years old or older.I have a visible tumor in my prostate or seminal vesicles on an MRI taken within the last 6 months.I have had treatment for prostate cancer, such as surgery or radiation.I have had radiation therapy to my pelvic area before.My cancer has spread to distant parts of my body.
Research Study Groups:
This trial has the following groups:- Group 1: HR-B (High-risk B)
- Group 2: HR-A (High-risk A)
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.
Does this research project include elderly participants?
"This medical trial is inviting applicants aged 18 and up, but no older than 100 years old."
Answered by AI
Does my condition fulfill the requirements for participation in this experiment?
"Individuals suffering from adenocarcinoma and between the ages of 18 to 100 are eligible for this medical trial. A maximum of one hundred patients may be admitted into the study."
Answered by AI
Are there any openings for enrolment in this clinical experiment?
"Affirmative. Evidenced by the clinicaltrials.gov portal, this medical trial is currently recruiting participants, with 100 needed from 1 site. It was initially published on September 24th 2018 and recently edited on September 2nd 2022."
Answered by AI
What is the scope of participants in this research endeavor?
"Affirmative. According to clinicaltrials.gov, the medical trial posted on September 24th 2018 is currently looking for volunteers. One hundred participants are needed from a single research centre."
Answered by AI
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