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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00621413

Enrollment

Registered

2008-02-22

Start date

2007-02-28

Completion date

2007-02-28

Last updated

2021-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.	5 years	Data collected for analysis will be total therapeutic dose delivered to the prostate by the Cs-131 brachytherapy implant treatment in units of Gy.

Secondary

Measure	Time frame	Description
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	Data collected for analysis will be the EPIC prostate cancer quality of life questionnaire.
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	Data collected for analysis will be PSA measurements.

Countries

United States

Outcome results