A Phase I Trial of Satraplatin Plus Radiation Therapy for Prostate Cancer Patients With Biochemical Recurrence

Prostate Cancer Clinical Trial

Official title: A Phase I Trial of Satraplatin Plus Radiation Therapy for Prostate Cancer Patients With Biochemical Recurrence Following Radical Prostatectomy

Status Terminated

Clinical Trial Summary

This study is designed to measure the impact of Satraplatin plus radiation therapy to the bed of the prostate in patients who have developed biochemical failure of their prostate cancer. The main objective of this study is to determine the maximum tolerated dose and dose limiting toxicity for the combination of satraplatin and radiation therapy and to determine the recommended dose for subsequent Phase II trials.

Clinical Trial Description

****Please Note: Dr.Howard Sandler's site will be open to accrual shortly, Dr. Sarantopoulos's site in San Antonio is open and recruiting patients.****

There were approximately 232,000 cases of prostate cancer diagnosed in the US in 2005. Most patients present with localized disease and undergo curative therapy, either radical prostatectomy (RP) or radiation therapy (RT). Although most men are cured after this therapy, approximately 30,000-50,000 annually in the US will develop recurrence after RP. For most of these patients, recurrence will be defined by biochemical recurrence (BCR), a rise in PSA with no other documented evidence of recurrence. Patients with BCR typically receive radiation therapy to the prostate bed. However, about 50% of these patients will develop distant recurrence outside of the pelvis and require systemic therapy.

Satraplatin is a third generation orally administered platinum compound. Early clinical studies demonstrated activity in tumors of the ovary and lung in addition to prostate cancer. Satraplatin has shown activity in prostate cancer in Phase II studies and has been evaluated in a pivotal Phase III study (The SPARC trial)as a single agent as second line therapy. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT00480623
• Study type: Interventional
• Source: Agennix
• Status: Terminated
• Phase: Phase 1
• Start date: May 2007
• Completion date: April 2008