Study on Shortened Proton Radiation Therapy for Low Risk Prostate Cancer
Sponsor: Proton Collaborative Group
ClinicalTrials ID:NCT01230866
This clinical trial is comparing two types of radiation therapy for prostate cancer: the standard treatment over 8-9 weeks and a new, shorter treatment over 1-2 weeks. The goal is to see if the shorter treatment is as effective or better.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to compare the effects of two different radiation therapy schedules for patients with low risk prostate cancer. One group will receive the standard radiation therapy, which involves 44 treatments over about 8½ to 9 weeks. The other group will receive a higher daily dose of radiation over just 5 treatments in 1 to 2 weeks. Researchers want to find out if the shorter treatment is as effective or even better than the standard treatment.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with prostate adenocarcinoma within the past year.
- Underwent a physical exam, including a prostate exam, within the last 90 days.
- Prostate biopsy results with a Gleason score between 2 and 6.
- PSA levels below 10 ng/ml, tested within 90 days before joining the study.
- Cancer stage T1a-T2a N0 M0, as determined by the doctor.
- No enlarged pelvic lymph nodes unless tested and found not cancerous.
- At least 18 years old.
- In good general health with an ECOG performance status of 0 or 1.
- IPSS score of 16 or lower.
- Willing to give informed consent and complete all required tests.
- Able to start treatment within 56 days of joining the study.
Exclusion Criteria
- Previous prostate surgery like prostatectomy or cryosurgery.
- Previous radiation treatment for prostate cancer.
- Ongoing hormone therapy during radiation.
- Active bowel conditions like rectal diverticulitis or Crohn's disease.
- Previous chemotherapy for prostate cancer.
- History of urethral stricture needing treatment.
- Currently taking blood thinners unless they can be paused if needed.
- Major medical, psychiatric, or addiction issues affecting participation.
- Other cancers within the last 5 years, except certain skin cancers.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic Cancer Center | 85054 | Phoenix | Arizona |
| Northwestern Medicine Chicago Proton Center | 60555 | Warrenville | Illinois |
| Maryland Proton Treatment Center | 21201 | Baltimore | Maryland |
| Oklahoma Proton Center | 73142 | Oklahoma City | Oklahoma |
| Hampton University Proton Therapy Institute | 23666 | Hampton | Virginia |
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