Duration of Suppression of Bone Turnover Following Treatment With Zoledronic Acid in Men With Metastatic CRPC

NCT01062503 | Completed

• 2 other identifiers: REB 09-0688-CPRIT9
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Bone is the most common site of metastases in prostate cancer and bone complications cause substantial morbidity to this population. Phase III studies have shown that zoledronic acid is effective in decreasing the morbidity associated with bone metastases. Zoledronic acid (ZA) is generally well tolerated but may have side effects such as hypocalcemia, renal impairment and osteonecrosis of the jaw. Administration of ZA as infrequently as once yearly is sufficient to prevent osteopenia or osteoporosis. The optimal treatment interval is unknown, but the drug is often empirically administered every 3-4 weeks. The cost of such treatment is high, and the risk of exposing patients (especially those at low risk) to potential serious side effects with uncertain benefit warrants investigation. This study will determine the duration of suppression of bone turnover in prostate cancer patients with bone metastases following a single infusion of Zoledronic Acid and its effect on quality of life.

Conditions

Metastatic Prostate Cancer; Bone Metastasis

Keywords

Cancer; Prostate; metastatic

Outcome Measures

Primary Outcomes (1)

• Patients given single dose of Zoledronic Acid 4mg IV

  baseline

Secondary Outcomes (3)

• Brief Pain Inventory Location Questionnaire

  Baseline, Q6weeks, Q12weeks, 26weeks

• FACT-BP Quality of Life Questionnaire

  Baseline, Q6weeks, Q12weeks, 26weeks

• We will monitor for uNTX, sCTX, BAP (fasting morning sample)

  Baseline, Q3wks, Q6wks, Q9wks Q12wks

Interventions

Zoledronic acid DRUG

ZA at a dose of 4mg will be administered by intravenous infusion over 15 minutes in at least 100mls of saline

Also known as: Zometa

Eligibility Criteria

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

Study Population

This is a non-randomized observational study

You may qualify if:

• Patients must have histologically confirmed prostate cancer that has become castration resistant
• Radiological or pathological evidence of bone metastases. (Positive bone scan, MRI, or CT or pathological fracture, or pathological sample from bone biopsy showing evidence of metastatic prostate cancer)
• Patient has not yet started on BP therapy for metastatic castration resistant prostate cancer
• Renal and hepatic function within the institutional normal range or at the discretion of the Investigator
• Age ≥ 18 years
• ECOG performance status ≤ 2
• Life expectancy \>6 months
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• Hypersensitivity or known allergy to bisphosphonates
• Patient who has received BP therapy for any reason within the past 1 year
• Acute or chronic renal insufficiency
• Evidence of infection/abscess on dental exam or recent dental extraction (within last 4 weeks)
• Acute pathological fracture, spinal cord compression, or hypercalcemia requiring urgent treatment (patient may enter study after acute issues are resolved)
• Patients with baseline hypocalcemia

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G2M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms; Neoplasm Metastasis

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ian F Tannock, MD, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2010
• First Posted: February 4, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 27, 2015

Record last verified: 2015-04

Locations

CA (1)