Back to resultsProton Beam Radiation Therapy for Early Stage Adenocarcinoma of the Prostate
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Proton Beam Radiation
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring proton beam radiation
Eligibility Criteria
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
Sites / Locations
- Massachusetts General Hospital
Outcomes
Primary Outcome Measures
To assess the late morbidity of 82 GY delivered to the prostate and surrounding tissues using proton beam radiation
Secondary Outcome Measures
To assess the acute morbidity following protocol treatment and to determine the ability of this treatment to control cancer.
Full Information
NCT ID
NCT00585962
First Posted
December 27, 2007
Last Updated
August 31, 2017
Sponsor
Massachusetts General Hospital
Collaborators
American College of Radiology Imaging Network
1. Study Identification
Unique Protocol Identification Number
NCT00585962
Brief Title
Proton Beam Radiation Therapy for Early Stage Adenocarcinoma of the Prostate
Official Title
A Phase II Study Using Proton Beam Radiation Therapy for Early Stage Adenocarcinoma of the Prostate
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
American College of Radiology Imaging Network
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
proton beam radiation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Radiation
Intervention Name(s)
Proton Beam Radiation
Intervention Description
Once a day, 5 days a week (Monday-Friday), for 8 weeks.
Primary Outcome Measure Information:
Title
To assess the late morbidity of 82 GY delivered to the prostate and surrounding tissues using proton beam radiation
Time Frame
3 years
Secondary Outcome Measure Information:
Title
To assess the acute morbidity following protocol treatment and to determine the ability of this treatment to control cancer.
Time Frame
3 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Zietman, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Proton Beam Radiation Therapy for Early Stage Adenocarcinoma of the Prostate
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