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Proton Beam Therapy

Proton SBRT for Prostate Cancer

Phase 2

Recruiting

Led By Shaakir Hasan, DO

Research Sponsored by The New York Proton Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male 18 years of age or older

Clinical T1-T2c disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years and 5 years

Awards & highlights

Study Summary

This trial is testing whether proton SBRT is as safe as photon SBRT for treating low- and intermediate-risk prostate cancer.

Who is the study for?

Men over 18 with low or intermediate-risk prostate cancer, a Gleason score ≤7, PSA ≤20 ng/ml, and no prior major prostate surgery. They must have a life expectancy of more than 2 years and be able to follow up for at least that time. Participants need an IPSS score ≤20, KPS ≥80%, and agree to specific procedures like fiducial marker placement.Check my eligibility

What is being tested?

The trial is testing pencil beam scanning proton SBRT as a treatment for prostate cancer. It involves delivering radiation in five sessions every other day. The main goal is to see if this method causes less severe urinary or gastrointestinal side effects compared to traditional treatments after two years.See study design

What are the potential side effects?

Potential side effects include severe urinary (GU) or gastrointestinal (GI) issues such as pain during urination, frequent urination, rectal bleeding or discomfort. These are monitored closely; the study aims for less than 5% of patients experiencing these grade 3+ toxicities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man aged 18 or older.

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My cancer is in an early stage and has not spread widely.

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I agree to have markers and a rectal spacer placed for my prostate treatment.

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I can carry out normal activities with minimal symptoms.

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My prostate cancer is low or intermediate risk with a Gleason score of 7 or less and PSA of 20 ng/ml or less.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years and 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years and 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years and 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

1. Grade 3+ GU/GI toxicity-free rate determined by CTCAE v5.0 grading.

Secondary outcome measures

1. Patient reported urinary symptoms determined by IPSS.

2. Patient reported urinary, bowel, and hormonal quality of life determined by EPIC-26.

3. Patient reported financial toxicity determined by COST

+6 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Stereotactic body radiation therapy (SBRT) with Pencil Beam Scanning (PBS) proton therapyExperimental Treatment1 Intervention

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

The New York Proton CenterLead Sponsor

2 Previous Clinical Trials

1,840 Total Patients Enrolled

1 Trials studying Prostate Cancer

1,800 Patients Enrolled for Prostate Cancer

Shaakir Hasan, DOPrincipal InvestigatorThe New York Proton Center

Daniel Gorovets, MDPrincipal InvestigatorThe New York Proton Center

3 Previous Clinical Trials

300 Total Patients Enrolled

3 Trials studying Prostate Cancer

300 Patients Enrolled for Prostate Cancer

Media Library

Pencil Beam Scanning Proton SBRT (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04842890 — Phase 2

Prostate Cancer Research Study Groups: Stereotactic body radiation therapy (SBRT) with Pencil Beam Scanning (PBS) proton therapy

Prostate Cancer Clinical Trial 2023: Pencil Beam Scanning Proton SBRT Highlights & Side Effects. Trial Name: NCT04842890 — Phase 2

Pencil Beam Scanning Proton SBRT (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04842890 — Phase 2

Frequently Asked Questions

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

Are new volunteers being taken for this experiment currently?

"The clinical trial was first posted on 1/8/2021 and was most recently updated on 4/9/2021, as reported by clinicaltrials.gov. The site currently lists the trial as seeking participants."

Answered by AI