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Proton Beam Therapy

Proton Beam Therapy for Prostate Cancer

Phase 2
Waitlist Available
Led By Richard Choo, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinical stage T1-2 N0 M0, Gleason Score 7, Prostate Specific Antigen (PSA) 20-100 ng/mL, or Clinical stage Any T N0 M0, Gleason Score 8-10, PSA ≤ 100 ng/mL, or Clinical stage T3-4 N0 M0, any Gleason Score, PSA ≤ 100 ng/mL, or Clinical stage T1-2 N0 M0, Gleason Score 4+3, PSA 10-20 ng/mL
Male; Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years post proton beam therapy
Awards & highlights

Study Summary

This trial is testing whether a shorter, more intense course of proton beam therapy is effective for high risk prostate cancer.

Who is the study for?
Men over 18 with high risk or unfavorable intermediate risk prostate cancer, confirmed within the last 6 months. They should have specific clinical stages and PSA levels, good liver and kidney function, and a performance score indicating they can carry out daily activities. Excluded are those who've had long-term hormone therapy for cancer, bowel disease history, hip replacements, prior pelvic radiation or surgery on the prostate, other recent cancers except skin cancer that's not melanoma.Check my eligibility
What is being tested?
The trial is testing a proton beam therapy regimen where the prostate and seminal vesicles receive one dose while pelvic nodes get another at the same time. The goal is to see how well this works over a five-week period for treating certain stages of prostate cancer.See study design
What are the potential side effects?
Potential side effects may include skin reactions in treated areas, fatigue, digestive issues like diarrhea or discomfort when urinating due to inflammation of bladder or rectum; however specifics will depend on individual patient responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer is in an early or specific advanced stage with certain PSA levels.
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I am a man aged 18 or older.
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My prostate cancer was confirmed by a biopsy within the last 6 months.
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I am fully active or can carry out light work.
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I am fully active or have minor restrictions in physical activity.
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I am a man aged 18 or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years post proton beam therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years post proton beam therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Late Grade ≥ 3 Gastrointestinal (GI) and Genitourinary (GU) Toxicity of Interest, Using the CTCAE v4.0
Secondary outcome measures
Acute Grade ≥ 3 GI and GU Toxicity of Interest Within 3 Months Post Proton Beam Therapy, Using the CTCAE v4.0
Disease-free Survival Including Freedom From PSA Relapse at 5 Years Post Proton Beam Therapy
Disease-specific Survival at 5 Years Post Proton Beam Therapy
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Hypofractionation Proton beam therapyExperimental Treatment1 Intervention
Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,176 Previous Clinical Trials
3,757,995 Total Patients Enrolled
31 Trials studying Prostate Cancer
7,932 Patients Enrolled for Prostate Cancer
Richard Choo, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
67 Total Patients Enrolled
1 Trials studying Prostate Cancer
67 Patients Enrolled for Prostate Cancer

Media Library

Prostate Cancer Research Study Groups: Hypofractionation Proton beam therapy

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any recruitment opportunities currently available for this medical trial?

"According to clinicaltrials.gov, this trial is not currently looking for participants. Initially posted on July 25th 2016 and last updated August 3rd 2022, it has since become dormant. There are however 1322 other medical trials actively recruiting patients now."

Answered by AI
~6 spots leftby Mar 2025