Bipolar Androgen-based Therapy for Prostate Cancer (BAT)
Condition: Recurrent Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Testosterone cypionate; Goserelin; Leuprolide
Intervention description: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.; Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an "LHRH agonist."; Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection.
Intervention MeSH terms: Methyltestosterone; Leuprolide; Goserelin; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Testosterone, Leuprolide, Goserelin

Summary:

      The purpose of this study is 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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age ≥ 18 years

          2. Performance status ≤2.

          3. Documented histologically confirmed adenocarcinoma of the prostate.

          4. No prior AD therapy (i.e. surgical castration LHRH agonist, LHRH antagonist) 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 ≥ 1 year prior to recurrence).

          5. No prior treatment with second line hormonal therapies (flutamide, bicalutamide,
             nilutamide, ketoconazole, abiraterone acetate or MDV3100) is permitted.

          6. Prior treatment with 5-alpha reductase inhibitors (e.g. finasteride or dutasteride)
             for treatment of benign prostatic hyperplasia (BPH) is permitted, but patients must be
             off therapy for ≥ 6 months prior to enrolling on study

          7. No prior treatment with chemotherapeutic regimens allowed.

          8. Prior treatment with non-hormonal investigational agents is permitted.

          9. Evidence of rising PSA on two successive dates > 2 weeks apart. There is no maximum or
             minimum PSA requirement to come on study.

         10. Patients must have ≤ 10 total sites of bone metastases and no evidence for lung or
             liver or other parenchymal metastases documented within 28 days of enrollment on trial

         11. Patient may have lymph node metastases with no single lymph node >5 cm short axis
             diameter

         12. Patients must be asymptomatic with no sites of pain due to prostate cancer.

        Exclusion Criteria:

          1. Evidence of serious and/or unstable pre-existing medical, psychiatric or other
             condition (including laboratory abnormalities) that could interfere with patient
             safety or provision of informed consent to participate in this study.

          2. Any psychological, familial, sociological, or geographical condition that could
             potentially interfere with compliance with the study protocol and follow-up schedule.

          3. Evidence of disease that, in the opinion of the investigator, would put the patient at
             risk from testosterone therapy (e.g. femoral metastases with concern over fracture
             risk, spinal metastases with concern over spinal cord compression, lymph node disease
             with concern for ureteral obstruction).

          4. Requires urinary catheterization for voiding as a result of tumor obstructing the
             urinary outflow tract; catheterization is permitted if due to a non-oncologic cause
             (e.g urethral stricture or atonic bladder).

          5. No prior history of deep venous thrombosis or pulmonary embolism within 5 years prior
             to enrollment in the study

          6. Abnormal liver function (bilirubin, AST, ALT ≥ 3 x upper limit of normal)

          7. Abnormal kidney function (serum creatinine ≥ 2 x upper limit of normal)

          8. Abnormal cardiac function as manifested by NYHA (New York Heart Association) class III
             or IV heart failure or history of a prior myocardial infarction (MI) within 5 years
             prior to enrollment in the study

          9. Inability to provide informed consent.