- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00585962
Proton Beam Radiation Therapy for Early Stage Adenocarcinoma of the Prostate
August 31, 2017 updated by: Anthony Laurence Zietman, MD, Massachusetts General Hospital
A Phase II Study Using Proton Beam Radiation Therapy for Early Stage Adenocarcinoma of the Prostate
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
- 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.
Study Type
Interventional
Enrollment (Actual)
57
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the late morbidity of 82 GY delivered to the prostate and surrounding tissues using proton beam radiation
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the acute morbidity following protocol treatment and to determine the ability of this treatment to control cancer.
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Anthony Zietman, MD, Massachusetts General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2004
Primary Completion (Actual)
March 1, 2006
Study Registration Dates
First Submitted
December 27, 2007
First Submitted That Met QC Criteria
December 27, 2007
First Posted (Estimate)
January 4, 2008
Study Record Updates
Last Update Posted (Actual)
September 5, 2017
Last Update Submitted That Met QC Criteria
August 31, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02-064
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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