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

NCT00582556 | Completed Phase 2 Results DMC

• 5 other identifiers: CO028072003-057A534260SMPH/MEDICINENCI-2011-00712
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

bone mineral density

Outcome Measures

Primary Outcomes (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.

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

  2 years

Secondary Outcomes (3)

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

  2 years

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

  2 Years

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

  2 Years

Study Arms (3)

1

ACTIVE COMPARATOR

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

Drug: Zometa

2

ACTIVE COMPARATOR

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

Drug: zometa

3

ACTIVE COMPARATOR

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.

Drug: Zometa

Interventions

Zometa 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

Also known as: zoledronic acid, lupron, zolodex

1

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Related Links

• University of Wisconsin Carbone Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Zoledronic Acid; Leuprolide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Dr. Douglas McNeel
• Organization: University of Wisconsin Carbone Cancer Center

dm3@medicine.wisc.edu

608-263-4198

Study Officials

• Douglas McNeel, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 28, 2007
• Study Start: April 1, 2003
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2013
• Last Updated: November 26, 2019
• Results First Posted: May 12, 2014

Record last verified: 2014-06

Locations

US (1)