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

Sponsor

IsoRay Medical, Inc. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT00621413

Collaborator

Swedish Medical Center (Other)

Enrollment

Locations

Patients Per Site

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Prostate Cancer

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

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

Anticipated Study Start Date :

Feb 1, 2007

Actual Primary Completion Date :

Feb 1, 2007

Actual Study Completion Date :

Feb 1, 2007

Outcome Measures

Primary Outcome Measures

The 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. [5 years]
Data collected for analysis will be total therapeutic dose delivered to the prostate by the Cs-131 brachytherapy implant treatment in units of Gy.

Secondary Outcome Measures

The analysis of treatment related morbidities following Cs-131 prostate brachytherapy in combination with external beam therapy for intermediate to high risk cancer of the prostate. [5 years]
Data collected for analysis will be the EPIC prostate cancer quality of life questionnaire.
The analysis of PSA control rates following Cs-131 prostate brachytherapy in combination with external beam therapy for intermediate to high risk cancer of the prostate. [5 years]
Data collected for analysis will be PSA measurements.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Arizona Oncology Services Foundation	Phoenix	Arizona	United States	85013
2	Eisenhower Medical Center	Rancho Mirage	California	United States	92270
3	Dorthory Schneider Cancer Center	San Mateo	California	United States	94401
4	Levine Cancer Center	Worcester	Massachusetts	United States	01605
5	St. Mary's Regional Medical Center	Reno	Nevada	United States	89503
6	Northshore Medical Accelerator	Smithtown	New York	United States	11787
7	Sentara Cancer Institute	Hampton	Virginia	United States	23666
8	Virginia Mason Medical Center	Seattle	Washington	United States	98101
9	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