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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


N/A
18 Years
N/A
Open (Enrolling by invite only)
Male
Prostate Cancer

Thank you

Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

The accumulation and 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.

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

John Sylvester, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seattle Prostate Institute / Swedish Hospital

Authority:

United States: Institutional Review Board

Study ID:

isoray_cs131_pc01

NCT ID:

NCT00621413

Start Date:

February 2007

Completion Date:

Related Keywords:

  • Prostate Cancer
  • prostate
  • cancer
  • intermediate risk
  • high risk
  • brachytherapy
  • Cesium-131
  • seed brachytherapy
  • intermediate and high risk cancer of the prostate
  • Prostatic Neoplasms

Name

Location

Virginia Mason Medical CenterSeattle, Washington  98111
Eisenhower Medical CenterRancho Mirage, California  92270
Arizona Oncology Services FoundationPhoenix, Arizona  85013
Dorthory Schneider Cancer CenterSan Mateo, California  94401
Levine Cancer CenterWorcester, Massachusetts  01605
St. Mary's Regional Medical CenterReno, Nevada  89503
Northshore Medical AcceleratorSmithtown, New York  11787
Sentara Cancer InstituteHampton, Virginia  23666
Seattle Prostate Institute / Swedish HospitalSeattle, Washington  98104