A Pilot Study of Parenteral Testosterone and Oral Etoposide as Therapy for Men With Castration Resistant Prostate Cancer
Status:
Completed
Trial end date:
2014-10-01
Target enrollment:
Participant gender:
Summary
The objective of the study is to determine if men with evidence of progressive prostate
cancer while on chronic androgen ablation of ≥ 1 year duration will exhibit a clinical
response following administration of parenteral testosterone and oral etoposide.
Treatment Plan: Eligible patients will continue on androgen ablative therapy with luteinizing
hormone-releasing hormone (LHRH) agonist (i.e. Zoladex or Lupron) if not surgically
castrated. Patients will receive intramuscular injection with testosterone cypionate at a
dose of 400 mg every month for a total of 3 injections (i.e. 3 months of therapy). This dose
was selected based on data demonstrating that it produces an initial supraphysiologic serum
level of testosterone (i.e. > 3-5 times normal level) with eugonadal levels achieved at the
end of two weeks. Beginning the day of the testosterone injection, patients will also receive
oral etoposide 100 mg/day in divided doses (50 mg q 12h) x 14 days out of 28 days per cycle.
After 3 months on therapy, patients will have repeat prostate specific antigen (PSA) and
bone/computed tomography (CT) scans to establish the effect of combined testosterone and
etoposide treatment on these parameters (i.e. "testosterone effect baseline"). Patients with
sustained elevations in PSA ≥ 50% above pre-testosterone treatment PSA levels after the
initial three months of testosterone and etoposide therapy will not receive continued therapy
and will come off study. Patients with PSA levels less than the peak serum PSA level seen
over the three month period (PSA decline) or patients with PSA ≤ 50% of pretreatment baseline
will receive a second 3 month course of monthly testosterone and etoposide therapy until
evidence of disease progression. Disease progression is defined as a PSA increase above the
PSA level obtained after 3 months on testosterone treatment over two successive measurements
2 weeks apart or evidence of new lesions or progression on bone/CT scans compared to baseline
studies. Patients who respond to initial treatment with testosterone and etoposide and then
show signs of progression will have the option of retreatment with testosterone alone after a
period of 3 months or greater off of the original therapy.
Phase:
N/A
Details
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins