- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00582556
Zometa on Bone Mineral Density in Prostate Cancer Patients Undergoing Androgen Ablation Therapy
Phase II Trial of Zometa on Bone Mineral Density on Patients With Stage D Prostate Cancer Undergoing Androgen Ablation Therapy
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Wisconsin
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Madison, Wisconsin, United States, 53792
- University of Wisconsin
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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
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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
Other Names:
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.
Other Names:
|
Active Comparator: 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
|
GnRH analogue 3-mo depot - q3 months for 1 yr andZometa 4 mg IV over 15 min x 1, given at mo 6
Other Names:
|
Active Comparator: 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.
|
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
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 2 years
|
Effects on bone mineral density were measured at four locations at six month intervals for 24 months.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Number of Subjects Who Had a Significant Increase of Peripheral Blood Markers of Bone Turnover.
Time Frame: 2 years
|
Serum bone-specific alkaline phosphatase was collected as the blood marker of bone turnover.
|
2 years
|
Number of Subjects Had a Significant Change in Immune Markers.
Time Frame: 2 Years
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Immune markers were measured by isolating gamma-delta T cells one month after treatment with zoledronic acid.
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2 Years
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Number of Subjects With Decreases in Prostate Specific Antigen (PSA) After Zoledronic Acid Prior to Beginning Androgen Deprivation Therapy
Time Frame: 2 Years
|
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. |
2 Years
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Hormonal
- Bone Density Conservation Agents
- Reproductive Control Agents
- Fertility Agents, Female
- Fertility Agents
- Leuprolide
- Zoledronic Acid
Other Study ID Numbers
- CO02807 (Other Identifier: University of Wisconsin Carbone Cancer Center)
- A534260 (Other Identifier: UW Madison)
- SMPH/MEDICINE (Other Identifier: UW Madison)
- 2003-057 (Other Identifier: Institutional Review Board)
- NCI-2011-00712 (Registry Identifier: NCI Trial ID)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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