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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
Must not have
Prior prostate cancer therapy such as: prostatectomy, cryotherapy, or hyperthermia
Prior systemic therapy (chemotherapy) for prostate cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years & 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had treatments like surgery, cryotherapy, or hyperthermia for prostate cancer.
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I have received chemotherapy for prostate cancer.
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My cancer has spread to distant parts of my body.
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I have had chemotherapy for prostate cancer.
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I have had radiation therapy to my pelvic area before.
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My cancer has spread to nearby lymph nodes.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to biochemical failure
Secondary study objectives
Analyze Quality of Life
Toxicity Assessment
Other study objectives
Salvage Androgen Deprivation Therapy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~20 spots leftby Dec 2025
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