Phase II Study of Proton Beam Radiation Therapy for Prostate Cancer
Sponsor: The New York Proton Center
ClinicalTrials ID:NCT04842890
This clinical trial is testing a new type of radiation therapy called pencil beam scanning proton therapy for men with low- and intermediate-risk prostate cancer. The study aims to see if this treatment is safe and effective, especially in terms of side effects related to the urinary and digestive systems.
Patient Parameters
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Program Overview
This study is exploring a new radiation treatment called pencil beam scanning proton therapy for men with low- and intermediate-risk prostate cancer. The treatment involves five sessions of radiation given every other day. The main goal is to see if this treatment causes fewer side effects, particularly those affecting the urinary and digestive systems, compared to traditional radiation methods. Doctors will monitor patients for side effects during and after treatment at regular intervals for up to two years. The study aims to enroll 61 participants over three years. If too many patients experience severe side effects, the study will pause to ensure safety. Researchers will also look at how the treatment affects patients' quality of life, including urinary, digestive, sexual, and financial aspects, using questionnaires. They will also track cancer markers and perform scans and biopsies to assess the treatment's effectiveness.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with low- or intermediate-risk prostate cancer confirmed by biopsy.
- Gleason score of 7 or lower.
- PSA level of 20 ng/ml or lower.
- Cancer stage T1 to T2c.
- Prostate size less than 100 cc as measured by MRI or CT scan.
- Male, 18 years or older.
- Good overall health with a performance score of 80% or higher.
- IPSS score of 20 or lower.
- Willing to have small markers placed in the prostate and a gel spacer to protect the rectum.
- Available for follow-up visits for at least two years.
Exclusion Criteria
- Previous prostate surgery, except for certain procedures done more than 12 weeks before starting the study.
- History of chronic prostate inflammation or urethral narrowing.
- Currently have another active cancer, except for non-melanoma skin cancer, unless the doctor believes there is less than a 5% chance of it returning within two years.
- Life expectancy of less than two years.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| The New York Proton Center | 10035 | New York | New York |
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