Zometa on Bone Mineral Density in Prostate Cancer Patients Undergoing Androgen Ablation Therapy

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborator: Novartis Pharmaceuticals
• Treatments: Androgens; Diphosphonates; Leuprolide; Zoledronic Acid

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