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

Withdrawn before enrolling

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00621413

Run by

IsoRay Medical, Inc.

People needed

0

Starts

2007-02-01

Expected to finish

2007-02-01

Last updated by the study team

2021-04-19

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: accepted.

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
• Any two or three intermediate risk factor

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

Where it is running

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

Full record on ClinicalTrials.gov

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