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

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Zometa

zometa

Zometa

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring bone mineral density

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

University of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Arm 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 and Zometa 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.

Outcomes

Primary Outcome Measures

The Number of Subjects Who Had Either an Increase or Decrease on Bone Mineral Density of the Lumbar Spine and Femoral Neck in Men Undergoing Androgen Deprivation Therapy for Prostate Adenocarcinoma.

Effects on bone mineral density were measured at four locations at six month intervals for 24 months.

Secondary Outcome Measures

The Number of Subjects Who Had a Significant Increase of Peripheral Blood Markers of Bone Turnover.

Serum bone-specific alkaline phosphatase was collected as the blood marker of bone turnover.

Number of Subjects Had a Significant Change in Immune Markers.

Immune markers were measured by isolating gamma-delta T cells one month after treatment with zoledronic acid.

Number of Subjects With Decreases in Prostate Specific Antigen (PSA) After Zoledronic Acid Prior to Beginning Androgen Deprivation Therapy

PSA response was measured by observing the serum PSA one week after beginning zoledronic acid and prior to beginning androgen deprivation therapy. Arm 2 and Arm 3 were not able to be assessed for this endpoint as all subjects were on androgen deprivation prior to receiving zoledronic acid.

Full Information

NCT ID

NCT00582556

First Posted

December 19, 2007

Last Updated

November 15, 2019

Sponsor

University of Wisconsin, Madison

Collaborators

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00582556

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Completed

Study Start Date

April 2003 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Wisconsin, Madison

Collaborators

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

bone mineral density

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm 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

Arm Title

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm Type

Active Comparator

Arm Description

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

Intervention Name(s)

Zometa

Other Intervention Name(s)

zoledronic acid, lupron, zolodex

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

Intervention Type

Drug

Intervention Name(s)

zometa

Other Intervention Name(s)

zoledronic acid, lupron, zolodex

Intervention Description

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

Intervention Name(s)

Zometa

Other Intervention Name(s)

zolodronic acid, lupron, zolodex

Intervention Description

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.

Primary Outcome Measure Information:

Title

The Number of Subjects Who Had Either an Increase or Decrease on Bone Mineral Density of the Lumbar Spine and Femoral Neck in Men Undergoing Androgen Deprivation Therapy for Prostate Adenocarcinoma.

Description

Effects on bone mineral density were measured at four locations at six month intervals for 24 months.

Time Frame

2 years

Secondary Outcome Measure Information:

Title

The Number of Subjects Who Had a Significant Increase of Peripheral Blood Markers of Bone Turnover.

Description

Serum bone-specific alkaline phosphatase was collected as the blood marker of bone turnover.

Time Frame

2 years

Title

Number of Subjects Had a Significant Change in Immune Markers.

Description

Immune markers were measured by isolating gamma-delta T cells one month after treatment with zoledronic acid.

Time Frame

2 Years

Title

Number of Subjects With Decreases in Prostate Specific Antigen (PSA) After Zoledronic Acid Prior to Beginning Androgen Deprivation Therapy

Description

Time Frame

2 Years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Douglas McNeel, MD

Organizational Affiliation

University of Wisconsin, Madison

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Wisconsin

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

12. IPD Sharing Statement

Links:

URL

https://cancer.wisc.edu

Description

University of Wisconsin Carbone Cancer Center

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

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