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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT00582556 (opens ClinicalTrials.gov in a new tab)Other idCO02807Other idCO02807Other id2003-057Other idA534260
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Overview

Status
Completed
Phase
Phase 2
Enrollment
44 participants (actual)
Sponsor
University of Wisconsin, Madison · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Apr 2003
Primary completion
Mar 2011
Completion
Mar 2013
First posted
28 Dec 2007 (estimated)
Last update posted
26 Nov 2019
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200420062008201020122014
  1. Ph 2

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

    NCT00582556

    Apr 2003 to Mar 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • ZometaDrug
  • zometaDrug
  • ZometaDrug

Arms3

  • 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

  • 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

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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

    Registry description

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

Secondary outcomes(3)

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

    Time frame · 2 years

    Registry description

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

  2. Number of Subjects Had a Significant Change in Immune Markers.

    Time frame · 2 Years

    Registry description

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

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

    Time frame · 2 Years

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 2 years

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.

GroupValue (participants)
Zometa Given 7 Days Prior to Beginning ADT14
Zometa Given at Month 615
Zometa Given Monthly, Months 6-1115
Secondary and other outcome results(3)
Secondary outcomeNumber· 2 years

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

GroupValue (participants)
Zometa Given 7 Days Prior to Beginning ADT0
Zometa Given at Month 60
Zometa Given Monthly, Months 6-110
Secondary outcomeNumber· 2 Years

Number of Subjects Had a Significant Change in Immune Markers.

GroupValue (participants)
Zometa Given 7 Days Prior to Beginning ADT0
Zometa Given at Month 60
Zometa Given Monthly, Months 6-110
Secondary outcomeNumber· 2 Years

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

GroupValue (participants)
Zometa Given 7 Days Prior to Beginning ADT0
Zometa Given at Month 6not posted
Zometa Given Monthly, Months 6-11not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Zometa Given 7 Days Prior to Beginning ADTGnRH 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 / 1414 / 14
Zometa Given at Month 6GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6–2 / 1515 / 15
Zometa Given Monthly x 6 MonthsGnRH 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.–2 / 1515 / 15

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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