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

NCT00621413 | Withdrawn

• 1 other identifier: isoray_cs131_pc01
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 9

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.

Conditions

Prostate Cancer

Keywords

prostate; cancer; intermediate risk; high risk; brachytherapy; Cesium-131; seed brachytherapy; intermediate and high risk cancer of the prostate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IsoRay Medical, Inc.: lead
• Swedish Medical Center: collaborator

Study Sites (9)

Arizona Oncology Services Foundation

Phoenix, Arizona, 85013, United States

Location

Eisenhower Medical Center

Rancho Mirage, California, 92270, United States

Location

Dorthory Schneider Cancer Center

San Mateo, California, 94401, United States

Location

Levine Cancer Center

Worcester, Massachusetts, 01605, United States

Location

St. Mary's Regional Medical Center

Reno, Nevada, 89503, United States

Location

Northshore Medical Accelerator

Smithtown, New York, 11787, United States

Location

Sentara Cancer Institute

Hampton, Virginia, 23666, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Seattle Prostate Institute / Swedish Hospital

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• John Sylvester, MD

  Seattle Prostate Institute / Swedish Hospital

  PRINCIPAL INVESTIGATOR

• Steve Kurtzman, MD

  Mills Peninsula Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2008
• First Posted: February 22, 2008
• Study Start: February 1, 2007
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: April 19, 2021

Record last verified: 2021-04

Locations

US (9)