A Pilot Study of Parenteral Testosterone and Oral Etoposide as Therapy for Men with Castration Resistant Prostate Cancer
To determine if men with progressive prostate cancer who have been on continuous hormone therapy for at least a year will have a clinical response to the administration of testosterone given intramuscularly and oral etoposide.
- Must be on continuous androgen ablative therapy (either surgically castrated or LHRH agonist) for at least one year. - Testosterone level less than 50ng/dl. - Rising PSA's on two successive dates at least one month apart. - No more than 2 prior chemotherapy regimens allowed. - No more than 2 prior second line hormonal therapies allowed. - Must be withdrawn from antiandrogens for greater than 6 weeks and have a documented rise in PSA following that 6 weeks. - Can have metastatic disease but no more than 5 sites. - Adequate kidney and liver function.
Patients will receive an intramuscular gluteal injection with testosterone cypoinate at a dose of 400mg every month for a total of 3 months. On the day of testosterone injection patients will begin taking etoposide orally daily for 14 days. this is followed by a 14 day rest period to make up a 28 day cycle. Following the 3 months of treatment patients will be re evaluated with CT scan and bone scan. If stable disease, patients will be allowed to continue on therapy.
06/18/2013 04:02 AM