Know Cancer

or
forgot password

Phase II Trial of Zometa on Bone Mineral Density on Patients With Stage D Prostate Cancer Undergoing Androgen Ablation Therapy


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

Phase II Trial of Zometa on Bone Mineral Density on Patients With Stage D Prostate Cancer Undergoing Androgen Ablation Therapy


Castration by GnRH agonist therapy with or without androgen antagonists has been a mainstay
for advanced prostate cancer. One of the most significant side effects of the use of
androgen ablative therapies has been a decrease in bone mineral density, potentially placing
patients at greater risk of osteoporosis and bone fractures. It is prudent to anticipate
this adverse effect of therapy and to minimize its severity with appropriate and timely
pharmacologic intervention. Zometa is a bisphosphonates and bisphosphonates are effective
inhibitors of osteoclastic bone resorption. Recent studies have shown that other
bisphosphonates were able to reduce the bone loss observed after 24 and 48 weeks of
treatment with a GnRH analogue. An unanswered question remains, however, in how frequently
these agents should be employed in clinical practice.

This is a three-arm randomized trial of Zometa® on bone mineral density in subjects with
stage D prostate cancer undergoing androgen ablation therapy. If subjects are enrolled in
Arm 1, the GnRH analogue would be administered every 3 months for 1 year. Four milligrams of
Zometa® would be administered IV over 15 minutes 7 days prior to beginning androgen
deprivation therapy. If subjects are enrolled in Arm 2, the GnRH analogue would be
administered every 3 months for one year, and 4 mg of Zometa® would be administered IV over
15 minutes at month 6. If subjects are enrolled in Arm 3, the GnRH analogue is administered
every 3 months for 1 year, with 4 mg of Zometa® administered IV over 15 minutes monthly for
6 months, beginning at month 6.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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 .

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Douglas McNeel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Institutional Review Board

Study ID:

CO02807

NCT ID:

NCT00582556

Start Date:

April 2003

Completion Date:

March 2013

Related Keywords:

  • Prostate Cancer
  • bone mineral density
  • Prostatic Neoplasms

Name

Location

University of Wisconsin Madison,, Wisconsin  53792-5666