A Phase I Trial of Satraplatin Plus Radiation Therapy for Prostate Cancer Patients With Biochemical Recurrence Following Radical Prostatectomy
****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
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine maximum tolerated dose and dose limiting toxicity for the combination of Satraplatin and radiation therapy.
Serum chemistry and CBC will be evaluated weekly. PSA level will be evaluated on Day on of week 5.
Howard Sandler, MD
University of Michigan
United States: Food and Drug Administration
|Medical College of Wisconsin||Milwaukee, Wisconsin 53226|
|University of California San Francisco||San Francisco, California 941104206|
|The University of Texas Health Science Center at San Antonio||San Antonio, Texas 78229|
|UT Southwestern Medical Center at Dallas||Dallas, Texas 75390|