Proton Beam Radiation Therapy for Early Stage Adenocarcinoma of the Prostate

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Massachusetts General Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
American College of Radiology Imaging Network
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00585962
First received: December 27, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Radiation: Proton Beam Radiation
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Using Proton Beam Radiation Therapy for Early Stage Adenocarcinoma of the Prostate

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • To assess the late morbidity of 82 GY delivered to the prostate and surrounding tissues using proton beam radiation [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the acute morbidity following protocol treatment and to determine the ability of this treatment to control cancer. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 85
Study Start Date: February 2004
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: Proton Beam Radiation
    Once a day, 5 days a week (Monday-Friday), for 8 weeks.
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00585962

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
American College of Radiology Imaging Network
Investigators
Principal Investigator: Anthony Zietman, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Anthony Zietman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00585962     History of Changes
Other Study ID Numbers: 02-064
Study First Received: December 27, 2007
Last Updated: December 27, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
proton beam radiation

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014