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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00621413
• Other study ID #: isoray_cs131_pc01
• Status: Withdrawn
• Start date: February 2007
• Est. completion date: February 2007

Study information

• Verified date: April 2021
• Source: IsoRay Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
United States	Sentara Cancer Institute	Hampton	Virginia
United States	Arizona Oncology Services Foundation	Phoenix	Arizona
United States	Eisenhower Medical Center	Rancho Mirage	California
United States	St. Mary's Regional Medical Center	Reno	Nevada
United States	Dorthory Schneider Cancer Center	San Mateo	California
United States	Seattle Prostate Institute / Swedish Hospital	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Northshore Medical Accelerator	Smithtown	New York
United States	Levine Cancer Center	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
IsoRay Medical, Inc.	Swedish Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Data collected for analysis will be total therapeutic dose delivered to the prostate by the Cs-131 brachytherapy implant treatment in units of Gy.	5 years
Secondary	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.	Data collected for analysis will be the EPIC prostate cancer quality of life questionnaire.	5 years
Secondary	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.	Data collected for analysis will be PSA measurements.	5 years