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Title:
A Pilot Study of Parenteral Testosterone and Oral Etoposide as Therapy for Men with Castration Resistant Prostate Cancer
Protocol Number:
J09121
Phase:
Pilot
Physician:
Samuel Denmeade
Purpose:
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.
Eligibility:
- 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 - Must be withdrawn from antiandrogens for greater than 6 weeks and have a documented rise in PSA following that 6 weeks.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.
Treatment:
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.
Population:
Adult
Last Update
07/22/2014 04:02 AM
 

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