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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)

Must not have

Previous cancer excluding non-melanoma skin cancer

Physically or mentally incapable of signing the consent form of their own volition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up monitored for 10 years after completion of radiation therapy

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had cancer before, but not skin cancer.

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I am unable to sign the consent form by myself due to physical or mental reasons.

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I have used hormone therapy for cancer treatment.

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I am under 18 years old.

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My prostate cancer is considered high risk.

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My cancer has spread to my lymph nodes.

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I have had surgery to remove my prostate.

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I have had brachytherapy for prostate cancer.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and monitored for 10 years after completion of radiation therapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dysuria - Change from baseline

Erectile Dysfunction - Change from baseline

Hematuria - Change from baseline

+3 more

Secondary study objectives

Overall Survival

Progression Free Survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 13Eligibility criteria met