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

This study is enrolling participants by invitation only.

First Received: February 12, 2008 Last Updated: February 21, 2008 History of Changes

Sponsors and Collaborators:	IsoRay Medical, Inc. Swedish Medical Center
Information provided by:	IsoRay Medical, Inc.
ClinicalTrials.gov Identifier:	NCT00621413

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

MedlinePlus related topics: Cancer Prostate Cancer Radiation Therapy

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, 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

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	100
Study Start Date:	February 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: 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
Seattle Prostate Institute / Swedish Hospital
Seattle, Washington, United States, 98104
Virginia Mason Medical Center
Seattle, Washington, United States, 98101

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

No publications provided

Responsible Party:	Seattle Prostate Institute / Mills Peninsula Hospital ( John Sylvester, MD / Steve Kurtzman, MD )
Study ID Numbers:	isoray_cs131_pc01
Study First Received:	February 12, 2008
Last Updated:	February 21, 2008
ClinicalTrials.gov Identifier:	NCT00621413 History of Changes
Health Authority:	United States: Institutional Review Board

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

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms

Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009