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Observation of Outcomes and Side Effects of Cesium-131 in Combination With External Beam Radiation for the Treatment of Intermediate to High Risk Prostate Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2008 by IsoRay Medical, Inc..
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00621413
First Posted: February 22, 2008
Last Update Posted: February 22, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Swedish Medical Center
Information provided by:
IsoRay Medical, Inc.
  Purpose
The purpose of this study is to observe PSA response and incidence of side effects in patients diagnosed with intermediate to high risk prostate cancer and treated with Cesium-131 in combination of external beam therapy.

Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dosimetric and Morbidity Outcomes of Cs-131 Brachytherapy in Combination With External Beam Radiation Therapy in Subjects With Intermediate to High Risk Adenocarcinoma of the Prostate: An Observational Study

Resource links provided by NLM:


Further study details as provided by IsoRay Medical, Inc.:

Primary Outcome Measures:
  • The accumulation and analysis of dosimetric data resultant from Cs-131 permanent prostate brachytherapy in combination with external beam radiation therapy in the setting of intermediate to high risk cancer of the prostate. [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • The accumulation and analysis of treatment related morbidities and PSA control rates following Cs-131 prostate brachytherapy in combination with external beam therapy for intermediate to high risk cancer of the prostate. [ Time Frame: 5 years ]

Estimated Enrollment: 100
Study Start Date: February 2007
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
diagnosed patients with intermediate to high risk cancer of the prostate. Patient will be in a Radiation Oncology setting.
Criteria

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the prostate
  • Clinical stage T1c - T2c (AJCC 6th Edition), NX/N0, M0
  • Karnofsky Performance Score of 90 to 100
  • Greater than or equal to 18 years of age
  • Prostate volumes by TRUS ≤ 60 cc
  • I-PSS score < 15 (alpha blockers allowed)
  • Signed study-specific informed consent form prior to study entry

Intermediate Risk prostate cancer as determined by the following:

  • Gleason sum of 7; PSA less than 10.1 ng/ml; Stage T2a or less
  • Gleason sum 6 or less; PSA >10.0 and < 20.1ng/ml; Stage T2a or less
  • Gleason sum 6 or less; PSA < 10.1; Stage T2b

High risk prostate cancer as determined by the following:

  • Any Gleason Sum; PSA greater than 20 ng/ml; Stage T2c or less
  • Gleason Sum > 7; Any PSA; Stage T2c or less
  • Any Gleason Sum; Any PSA; Stage T2c
  • Any two or three intermediate risk factor

Exclusion Criteria:

  • Lymph node involvement (N1)
  • Evidence of distant metastases (M1)
  • Any hormonal blockade or therapy that:

    • Has persisted for more than 6 months by time of protocol screening; OR
    • Is ongoing within 3 months of study enrollment
  • Radical surgery for carcinoma of the prostate
  • Prior pelvic radiation
  • Previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers unless disease-free for ≥ 5 years
  • Major medical or psychiatric illness, which in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up
  • Hip prosthesis
  • Inability or refusal to provide informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00621413


Locations
United States, Arizona
Arizona Oncology Services Foundation
Phoenix, Arizona, United States, 85013
United States, California
Eisenhower Medical Center
Rancho Mirage, California, United States, 92270
Dorthory Schneider Cancer Center
San Mateo, California, United States, 94401
United States, Massachusetts
Levine Cancer Center
Worcester, Massachusetts, United States, 01605
United States, Nevada
St. Mary's Regional Medical Center
Reno, Nevada, United States, 89503
United States, New York
Northshore Medical Accelerator
Smithtown, New York, United States, 11787
United States, Virginia
Sentara Cancer Institute
Hampton, Virginia, United States, 23666
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Seattle Prostate Institute / Swedish Hospital
Seattle, Washington, United States, 98104
Sponsors and Collaborators
IsoRay Medical, Inc.
Swedish Medical Center
Investigators
Principal Investigator: John Sylvester, MD Seattle Prostate Institute / Swedish Hospital
Principal Investigator: Steve Kurtzman, MD Mills Peninsula Hospital
  More Information

Responsible Party: John Sylvester, MD / Steve Kurtzman, MD, Seattle Prostate Institute / Mills Peninsula Hospital
ClinicalTrials.gov Identifier: NCT00621413     History of Changes
Other Study ID Numbers: isoray_cs131_pc01
First Submitted: February 12, 2008
First Posted: February 22, 2008
Last Update Posted: February 22, 2008
Last Verified: February 2008

Keywords provided by IsoRay Medical, Inc.:
prostate
cancer
intermediate risk
high risk
brachytherapy
Cesium-131
seed brachytherapy
intermediate and high risk cancer of the prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases