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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 below
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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 weeks
Treatment ~ Varies
Follow Up ~2 years & 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years & 5 years for reporting.

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

Find a Location

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

Hypofractionated Proton Therapy (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02040610 — N/A
Prostate Cancer Research Study Groups: Low Risk Prostate Cancer, Intermediate Risk Prostate Cancer
Prostate Cancer Clinical Trial 2023: Hypofractionated Proton Therapy Highlights & Side Effects. Trial Name: NCT02040610 — N/A
Hypofractionated Proton Therapy (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02040610 — N/A

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
~21 spots leftby May 2025