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

Prostate Cancer

Intervention / Treatment

Radiation: Proton Beam Radiation

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)

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

United States
- 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

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

Massachusetts General Hospital

Collaborators

American College of Radiology Imaging Network

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