Clinical trial NCT00621413: 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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Prostate Cancer
Keywords: prostate
cancer
intermediate risk
high risk
brachytherapy
Cesium-131
seed brachytherapy
intermediate and high risk cancer of the prostate
Lead sponsor: IsoRay Medical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Swedish Medical Center
First posted: 2008-02-22
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: 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.
timeFrame: 5 years
Secondary outcomes:
measure: 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.
timeFrame: 5 years
measure: 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.
timeFrame: 5 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Oncology Services Foundation
state: Arizona
city: Rancho Mirage
country: United States
facility: Eisenhower Medical Center
state: California
city: San Mateo
country: United States
facility: Dorthory Schneider Cancer Center
state: California
city: Worcester
country: United States
facility: Levine Cancer Center
state: Massachusetts
city: Reno
country: United States
facility: St. Mary's Regional Medical Center
state: Nevada
city: Smithtown
country: United States
facility: Northshore Medical Accelerator
state: New York
city: Hampton
country: United States
facility: Sentara Cancer Institute
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: Seattle Prostate Institute / Swedish Hospital
state: Washington
Study officials:
affiliation: Seattle Prostate Institute / Swedish Hospital
name: John Sylvester, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mills Peninsula Hospital
name: Steve Kurtzman, MD
role: PRINCIPAL_INVESTIGATOR
References: