A Trial of Samarium 153 Followed by Salvage Prostatic Fossa 3D-CRT or IMRT Irradiation in High-Risk, Clinically Non-Metastatic Prostate Cancer After Radical Prostatectomy — 0622  

Non-metastatic Prostate Cancer Clinical Trial

Official title: A Phase II Trial of Samarium 153 Followed by Salvage Prostatic Fossa 3D-CRT or IMRT Irradiation in High-Risk, Clinically Non-Metastatic Prostate Cancer After Radical Prostatectomy

Status Recruiting

Clinical Trial Summary

The pupose of this study is to assess the effectiveness of Samarium 153 administration, as determined by a 30% decline in the PSA within 12 weeks, as compared to baseline, in a population of men with high risk, clinically non-metastatic prostate cancer after a radical prostatectomy.

Clinical Trial Description

Patients with high-risk and clinically non-metastatic cancer who have a rising PSA level after a radical prostatectomy are elgible to enter this phase II trial. Initially, patients will receive Samarium 153 2.0 mCi/kg as an IV injection by the radiation oncologist one time. Twelve weeks later toxicity and PSA response will be evaluated. Next patients will receive 3D-CRT or IMRT 64.8-70.2 Gy to the prostatic fossa. If there is no PSA response at 24 weeks, patients will begin hormonal therapy at the discretion of their physicians for a suggested 2 year period. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Non-metastatic Prostate Cancer
• Post Radical Prostatectomy
• Prostatic Neoplasms

• NCT number: NCT01317043
• Study type: Interventional
• Source: Sentara Norfolk General Hospital
• Status: Recruiting
• Phase: Phase 2
• Start date: July 2007