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

Launched by ISORAY MEDICAL, INC. · Feb 21, 2008

Keywords

ClinConnect Summary

No description provided

Gender

MALE

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