Proton Beam Radiation Therapy for Early Stage Adenocarcinoma of the Prostate
Completed · Phase 2
Conditions studied: Prostate Cancer
In brief
The primary purpose of this study is to determine if high doses of radiation using proton beam can be given safely with low and acceptable side effects. This study will also gather data to determine the ability of the proton beam to eradicate prostate cancer. Proton beam radiation is a very accurate kind of treatment that has been shown to affect less normal tissue than a regular radiation beam.
Key facts
- Study ID
- NCT00585962
- Run by
- Massachusetts General Hospital
- People needed
- 57
- Starts
- 2004-02-01
- Last updated by the study team
- 2017-09-05
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Patients with previously treated adenocarcinoma of the stages T1c-T2b and Gleason of equal to or greater than 5.
- PSA values of equal to or less than 15 ng/ml must be demonstrated within two months prior to study entry and greater than 3 weeks after prostate biopsy.
- Zubrod status 0-1.
- No evidence of distant metastasis.
- No evidence of other cancer. Prior malignancy does not exclude the patient if disease free for greater than five years.
You may not qualify if…
- Clinical stages T2c or above.
- PSA greater than 15.
- Any patient with T1c disease, a PSA less than or equal to 4 and Gleason sum less than 6.
- Evidence of lymph node involvement if lymph node sampling performed.
- Previous prostate surgery to include: simple prostatectomy, TURP, hyperthermia and cryosurgery.
- Previous prostate radiation.
- Prior hormonal therapy.
- History of inflammatory bowel disease even if currently inactive or controlled on medication.
- Prior systemic chemotherapy.
- History of proximal urethral stricture requiring dilatation.
- Current and continuing anticoagulation with Coumadin or equivalent.
- Major medical or psychiatric illness
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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