A Phase II Study of Bipolar Androgen-based Therapy for Men with Androgen Ablation NaÃ¯ve Recurrent Prostate Cancer
To determine the safety and clinical effects of alternating androgen deprivation therapy with testosterone therapy in men with recurrent prostate cancer as first line hormonal therapy, to assess the effect of alternating therapy on quality of life and metabolic changes associated with androgen-deprivation therapy
Must be at least 18 years, Must have good physical status, must have confirmed adenocarcinoma of the prostate, must have had no prior androgen deprivation (AD)therapy as treatment for recurrent or metastatic disease (may have received neoadjuvant, concurrent and/or adjuvant AD therapy in the context of definitive local therapy if it was administered ï¿½ 1 year prior to recurrence), no prior treatment with second line hormonal therapies, no prior treatment with chemotherapeutic regimens, rising PSA on two successive dates greater than 2 weeks apart, must have ï¿½ 5 total sites of bone metastases and no evidence for lung, liver or other non-bone parenchymal metastases documented within 28 days of enrollment on trial, may have lymph node metastases with no single lymph node greater than 5 cm short axis diameter, must be asymptomatic with no sites of pain due to prostate cancer, must not require urinary catheterization for voiding, must have normal kidney and liver functions, must have normal heart function, must not be surgically castrated prior to consent
After signing informed consent patients will undergo screening including blood work/ EKGs/ Scans/ among other testing, if patient meets eligibility requirements he will begin androgen deprivation therapy (ADT) with an LHRH agonist (i.e. Zoladex, Lupron or Eligard) if not surgically castrated for a total of 6 months, after this initial 6 months lead-in phase patients will continue on ADT every three months but will also receive an intramuscular gluteal injection with testosterone cypionate (T) every 4 weeks for a total of 3 injections (i.e. 12 week constituting one T cycle), patients will then cycle back to ADT only for 12 weeks (i.e. one ADT cycle), this will then be followed by another 12 week cycle of T injections followed by a 12 week cycle of ADT monotherapy, subjects will then be off study, with the option to continue on intermittent or continuous ADT at the discretion of their treating physician.
12/08/2013 04:02 AM