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Proton Therapy for Prostate Cancer
N/A
Waitlist Available
Led By William Barrett, MD
Research Sponsored by University of Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Physically and mentally capable of signing the consent form of their own volition
Diagnosis of low risk prostate cancer (T1c-T2a, Gleason 6, Prostate Specific Antigen (PSA) <10) -OR- Diagnosis of intermediate risk prostate cancer (T1c-T2c, Gleason 7 and/or PSA 10- 20)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up monitored for 10 years after completion of radiation therapy
Awards & highlights
Study Summary
This trial is testing proton therapy as a boost to regular radiation therapy to see if it decreases toxicity and is more effective in treating prostate cancer.
Who is the study for?
Men over 18 with low (T1c-T2a, Gleason 6, PSA <10) or intermediate risk (T1c-T2c, Gleason 7 and/or PSA 10-20) prostate cancer can join. They must be able to consent and have a life expectancy of more than 10 years. Those with high-risk cancer, prior treatments like prostatectomy or brachytherapy, other cancers except non-melanoma skin cancer, or under hormone therapy cannot participate.Check my eligibility
What is being tested?
The trial is testing if using proton radiation as an additional treatment after photon IMRT reduces side effects in treating prostate cancer compared to just photon IMRT. It also looks at how long patients stay disease-free and their overall survival after this combined treatment.See study design
What are the potential side effects?
Potential side effects may include typical reactions from radiation therapy such as fatigue, skin irritation in the treated area, urinary issues like increased frequency or discomfort during urination, bowel changes including diarrhea or rectal bleeding.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to understand and sign the consent form by myself.
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My prostate cancer is classified as low or intermediate risk.
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I am 18 years old or older.
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I have low risk prostate cancer.
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My prostate cancer is at an intermediate stage.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ monitored for 10 years after completion of radiation therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~monitored for 10 years after 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
Dysuria - Change from baseline
Erectile Dysfunction - Change from baseline
Hematuria - Change from baseline
+3 moreSecondary outcome measures
Overall Survival
Progression Free Survival
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Prospective Treatment GroupExperimental Treatment1 Intervention
Proton Boost
Group II: Retrospective Comparison GroupActive Control1 Intervention
Retrospective patients previously treated with standard of care photon therapy. There is no patient interaction with this group. Data collection from medical records only.
Find a Location
Who is running the clinical trial?
University of CincinnatiLead Sponsor
427 Previous Clinical Trials
634,352 Total Patients Enrolled
4 Trials studying Prostate Cancer
439 Patients Enrolled for Prostate Cancer
William Barrett, MDPrincipal InvestigatorUniversity of Cincinnati
1 Previous Clinical Trials
200 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My prostate cancer is classified as low or intermediate risk.I am 18 years old or older.I have low risk prostate cancer.I am unable to sign the consent form by myself due to physical or mental reasons.I am under 18 years old.I have had cancer before, but not skin cancer.I am able to understand and sign the consent form by myself.My prostate cancer is considered high risk.I have used hormone therapy for cancer treatment.My prostate cancer is at an intermediate stage.My cancer has spread to my lymph nodes.I have had surgery to remove my prostate.I have had brachytherapy for prostate cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Prospective Treatment Group
- Group 2: Retrospective Comparison Group
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 any remaining vacancies in this clinical experiment?
"This clinical trial, which was first posted on April 16th 2018 and last updated July 1st 2021 is not recruiting participants at this time. Nevertheless, there are over 1300 other studies that are currently seeking volunteers."
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