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 - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 12, 2008

Last Updated Date

February 21, 2008

Start Date ^†

February 2007

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00621413 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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

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.

Detailed Description

Study Phase

Study Type ^†

Observational

Study Design ^†

Cohort, Prospective

Condition ^†

Prostate Cancer

Intervention ^†

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Enrolling by invitation

Enrollment ^†

100

Completion Date

Primary Completion Date

Eligibility 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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00621413

Responsible Party

John Sylvester, MD / Steve Kurtzman, MD, Seattle Prostate Institute / Mills Peninsula Hospital

Secondary IDs ^††

Study Sponsor ^†

IsoRay Medical, Inc.

Collaborators ^††

Swedish Medical Center

Investigators ^†

Principal Investigator:	John Sylvester, MD	Seattle Prostate Institute / Swedish Hospital
Principal Investigator:	Steve Kurtzman, MD	Mills Peninsula Hospital

Information Provided By

IsoRay Medical, Inc.

Verification Date

February 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.