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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Prostate Cancer

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Arizona Oncology Services Foundation
  • California
    • Rancho Mirage, California, United States, 92270
      • Eisenhower Medical Center
    • San Mateo, California, United States, 94401
      • Dorthory Schneider Cancer Center
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • Levine Cancer Center
  • Nevada
    • Reno, Nevada, United States, 89503
      • St. Mary's Regional Medical Center
  • New York
    • Smithtown, New York, United States, 11787
      • Northshore Medical Accelerator
  • Virginia
    • Hampton, Virginia, United States, 23666
      • Sentara Cancer Institute
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center
    • Seattle, Washington, United States, 98104
      • Seattle Prostate Institute / Swedish Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• 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

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2007
• Primary Completion (ACTUAL): February 1, 2007
• Study Completion (ACTUAL): February 1, 2007

Study Registration Dates

• First Submitted: February 12, 2008
• First Submitted That Met QC Criteria: February 21, 2008
• First Posted (ESTIMATE): February 22, 2008

Study Record Updates

• Last Update Posted (ACTUAL): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 14, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: cancer; prostate; brachytherapy; high risk; intermediate risk; Cesium-131; seed brachytherapy; intermediate and high risk cancer of the prostate
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: isoray_cs131_pc01