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Proton Beam Therapy
Hypofractionated Proton Therapy for Prostate Cancer
N/A
Recruiting
Led By J. Ben Wilkinson, M.D.
Research Sponsored by Provision Center for Proton Therapy
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No prior radiotherapy to the pelvic area
Gleason Score < 7
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years & 5 years
Awards & highlights
Study Summary
This trial is testing whether a more abbreviated course of proton therapy is just as effective for low and intermediate risk prostate cancer patients as the current standard of care, which is a longer course of proton therapy.
Who is the study for?
Men over 18 with low or intermediate risk prostate cancer, PSA <20 ng/mL, ECOG status 0-1, no evidence of distant metastases or regional lymph node involvement. Eligible patients must have a Gleason Score <7 and clinical stage T1-T2c. Prior systemic therapy for prostate cancer disqualifies participation.Check my eligibility
What is being tested?
The trial is testing moderate hypofractionated proton therapy against conventional regimens in treating low and intermediate risk prostate cancer. It aims to compare quality of life outcomes and early/late gastrointestinal/genitourinary toxicities.See study design
What are the potential side effects?
Potential side effects may include issues related to the gastrointestinal system (like upset stomach) and genitourinary system (such as urinary problems), which will be monitored against those from standard treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not had radiation treatment to my pelvic area.
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My prostate cancer has a Gleason score of less than 7.
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I am fully active or can carry out light work.
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I am 18 years old or older.
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I have not had any treatment for prostate cancer before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years & 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years & 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to biochemical failure
Secondary outcome measures
Analyze Quality of Life
Toxicity Assessment
Other outcome measures
Salvage Androgen Deprivation Therapy
Trial Design
2Treatment groups
Active Control
Group I: Low Risk Prostate CancerActive Control1 Intervention
Hypofractionated Proton Therapy 62 Gy (RBE) in 20 fractions of 3.1 Gy (RBE) over 4 weeks
Group II: Intermediate Risk Prostate CancerActive Control1 Intervention
Hypofractionated Proton Therapy 62 Gy (RBE) in 20 fractions of 3.1 Gy (RBE) over 4 weeks
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Who is running the clinical trial?
Provision Center for Proton TherapyLead Sponsor
2 Previous Clinical Trials
754 Total Patients Enrolled
1 Trials studying Prostate Cancer
454 Patients Enrolled for Prostate Cancer
Center for Biomedical Research, LLCOTHER
1 Previous Clinical Trials
300 Total Patients Enrolled
J. Ben Wilkinson, M.D.Principal InvestigatorProvision Center for Proton Therapy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a physical exam to determine the stage of my prostate cancer.I was diagnosed with prostate cancer in the last year.I don't need a bone scan if I have only one risk factor, but I must have a negative bone scan if I have two or three risk factors.I can understand and agree to the study's requirements.My recent scans show no cancer spread to bones.I can start recommended therapy within 12 weeks of signing up.I have high-risk prostate cancer but am not a candidate for pelvic lymph node radiation.I have received chemotherapy for prostate cancer.My cancer has spread to distant parts of my body.I have had treatments like surgery, cryotherapy, or hyperthermia for prostate cancer.I have had chemotherapy for prostate cancer.My breast cancer is in an early stage (T1-T2c).My lymph nodes are either small or stable, as confirmed by my doctor.My blood counts meet the required levels for platelets, neutrophils, and hemoglobin.I have not had radiation treatment to my pelvic area.My prostate cancer has a Gleason score of less than 7.I am fully active or can carry out light work.I am 18 years old or older.I have had radiation therapy to my pelvic area before.My cancer has spread to nearby lymph nodes.I have not had any treatment for prostate cancer before.
Research Study Groups:
This trial has the following groups:- Group 1: Low Risk Prostate Cancer
- Group 2: Intermediate Risk Prostate Cancer
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.
How many participants are involved in this research endeavor?
"Affirmative. According to the details hosted on clinicaltrials.gov, this medical study is actively enrolling participants; having first been posted on January 1st 2014 and last updated April 3rd 2019. It requires 235 individuals from two different sites for completion."
Answered by AI
Are there any remaining patient openings for this experiment?
"The details on clinicaltrials.gov denote that this experiment is currently seeking participants with its inception date being 1/1/2014 and latest adjustment occurring 4/3/2019."
Answered by AI
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