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

NCT ID: NCT00582556

Last Updated: 2019-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30
• Study Completion Date: 2013-03-31

Brief 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.

Detailed Description

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: ACTIVE_COMPARATOR

Zometa

Intervention Type: DRUG

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

2

GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6

Group Type: ACTIVE_COMPARATOR

zometa

Intervention Type: DRUG

GnRH analogue 3-mo depot - q3 months for 1 yr andZometa 4 mg IV over 15 min x 1, given at mo 6

3

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.

Group Type: ACTIVE_COMPARATOR

Zometa

Intervention Type: DRUG

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.

Interventions

Zometa

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

Intervention Type: DRUG

zometa

GnRH analogue 3-mo depot - q3 months for 1 yr andZometa 4 mg IV over 15 min x 1, given at mo 6

Intervention Type: DRUG

Zometa

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 Type: DRUG

Other Intervention Names

zoledronic acid; lupron; zolodex; zoledronic acid; lupron; zolodex; zolodronic acid; lupron; zolodex

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Douglas McNeel, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin

Madison, Wisconsin, United States

Countries

United States

Related Links

https://cancer.wisc.edu

University of Wisconsin Carbone Cancer Center

Other Identifiers

CO02807

Identifier Type: OTHER

Identifier Source: secondary_id

2003-057

Identifier Type: OTHER

Identifier Source: secondary_id

A534260

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/MEDICINE

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2011-00712

Identifier Type: REGISTRY

Identifier Source: secondary_id

CO02807

Identifier Type: -

Identifier Source: org_study_id