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

IsoRay

Status: Withdrawn

Conditions: Prostate Cancer

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00621413

isoray_cs131_pc01

Details and patient eligibility

About

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.

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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