Proton Beam Radiation Therapy for Early Stage Adenocarcinoma of the Prostate

NCT00585962 | Completed Phase 2 DMC

• 1 other identifier: 02-064
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

proton beam radiation

Outcome Measures

Primary Outcomes (1)

• To assess the late morbidity of 82 GY delivered to the prostate and surrounding tissues using proton beam radiation

  3 years

Secondary Outcomes (1)

• To assess the acute morbidity following protocol treatment and to determine the ability of this treatment to control cancer.

  3 years

Interventions

Proton Beam Radiation RADIATION

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• American College of Radiology Imaging Network: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Study Officials

• Anthony Zietman, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 27, 2007
• First Posted: January 4, 2008
• Study Start: February 1, 2004
• Primary Completion: March 1, 2006
• Last Updated: September 5, 2017

Record last verified: 2017-08

Locations

US (1)