Proton Beam Radiation Therapy for Early Stage Adenocarcinoma of the Prostate

NCT ID: NCT00585962

Last Updated: 2017-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Proton Beam Radiation

Once a day, 5 days a week (Monday-Friday), for 8 weeks.

Intervention Type: 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

American College of Radiology Imaging Network

NETWORK

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anthony Laurence Zietman, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anthony Zietman, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

02-064

Identifier Type: -

Identifier Source: org_study_id