Zometa on Bone Mineral Density in Prostate Cancer Patients Undergoing Androgen Ablation Therapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Zometa; zometa; Zometa
Intervention description: GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy; GnRH analogue 3-mo depot - q3 months for 1 yr andZometa 4 mg IV over 15 min x 1, given at mo 6; GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
Intervention MeSH terms: Zoledronic Acid; Leuprolide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: bone mineral density

Summary:

      The purpose of this research is to determine the effect of timing of Zometa® administration
      on bone mineral density of the lumbar spine and femoral neck in men undergoing androgen
      deprivation therapy for prostate adenocarcinoma. In addition, the researchers will also
      determine the effects of treatment with Zometa® on peripheral blood markers of bone turnover,
      on peripheral blood gd T-cell frequencies and function, and to determine if the above
      treatments elicit prostate antigen-specific IgG immune responses. The effects of the above
      treatments on serial serum PSA measurements will also be examined.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have a histologic diagnosis of adenocarcinoma of the prostate.

          -  For patients without clinical metastasis treated by surgery, serum PSA values must be
             > 0.2 ng/ml by two measurements at least two weeks apart. In patients treated with
             ablative radiation therapy without clinical metastasis, three consecutive increases in
             serum PSA must be documented, with at least a one-month interval between values with
             the final PSA > 2ng/m as evidence of biochemical PSA failure. P

          -  Patients who have not had prior primary therapy such as radiation or surgery, are
             required to have a detectable PSA of at least 0.2 ng/ml.

          -  Patients with evidence of metastatic disease are eligible irrespective of serum PSA
             level.

          -  Prior history of a second malignancy is allowed if treated with curative intent and
             patient has been free of disease greater than five years

          -  ECOG performance status of < 2.

        Exclusion Criteria:

          -  Prior treatment with a GnRH analogue or anti-androgen.

          -  Evidence of immunosuppression or have been treated with immunosuppressive therapy,
             such as chemotherapy, chronic treatment dose corticosteroids, or radiation therapy to
             bones, within 6 months of study enrollment

          -  Current or treatment within 4 weeks with estrogen or estrogenic agents (including
             herbal compound PC-SPES)

          -  Current or treatment within 4 weeks with herbal compounds for prostate cancer such as
             PC-SPES or saw palmetto

          -  Current or treatment within 4 weeks with megestrol

          -  Current or prior treatment with a bisphosphonate, calcitonin, or other bone
             resorptive/anabolic agents

          -  Current use of oral corticosteroids or any such use within the past 6 months

          -  Current use of potentially bone-toxic anticonvulsants (phenytoin, or carbamazepine)

          -  History of orchiectomy

          -  Hypocalcemia