A Phase II Study Using Proton Beam Radiation Therapy for Early Stage Adenocarcinoma of the Prostate
18 Years
N/A
Male
Prostate Cancer
Trial Information
A Phase II Study Using Proton Beam Radiation Therapy for Early Stage Adenocarcinoma of the Prostate
- Radiation therapy to the pelvis and prostate will be given once a day, 5 days a week
(Monday-Friday), for 8 weeks. Each treatment takes about 10-20 minutes.
- Participants will be seen once a week for the entire 8 weeks by their study doctor to
monitor and record any side effects. At the end of radiation therapy, participants
will have a history and physical examination. Follow-up visits with the study doctor
will be done at weeks 13 and 26 and then every 6 months for 3 years, then annually to
year five.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To assess the late morbidity of 82 GY delivered to the prostate and surrounding tissues using proton beam radiation
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Anthony Zietman, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Massachusetts General Hospital
Authority:
United States: Institutional Review Board
Study ID:
02-064
NCT ID:
NCT00585962
Start Date:
February 2004
Completion Date:
Related Keywords:
- Prostate Cancer
- proton beam radiation
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Prostatic Neoplasms
Name | Location |
|---|---|
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
