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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01062503
First received: February 3, 2010
Last updated: April 24, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention
Metastatic Prostate Cancer
Bone Metastasis
Drug: Zoledronic acid

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Duration of Suppression of Bone Turnover Following Treatment With Zoledronic Acid in Men With Metastatic Castration Resistant Prostate Cancer

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Patients given single dose of Zoledronic Acid 4mg IV [ Time Frame: baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Brief Pain Inventory Location Questionnaire [ Time Frame: Baseline, Q6weeks, Q12weeks, 26weeks ] [ Designated as safety issue: No ]
  • FACT-BP Quality of Life Questionnaire [ Time Frame: Baseline, Q6weeks, Q12weeks, 26weeks ] [ Designated as safety issue: No ]
  • We will monitor for uNTX, sCTX, BAP (fasting morning sample) [ Time Frame: Baseline, Q3wks, Q6wks, Q9wks Q12wks ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: January 2010
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Zoledronic acid
    ZA at a dose of 4mg will be administered by intravenous infusion over 15 minutes in at least 100mls of saline
    Other Name: Zometa
Detailed Description:

The bone is the most common site of metastasis in men with prostate cancer, and that bone metastases are associated with a significant risk of SREs. Prevention and delay in onset of SREs has been demonstrated with use of ZA. The optimal dosing frequency of ZA is not known in this population but it is usually given every 3-4 weeks, whereas injections as infrequently as once yearly protect from bone loss in patients without bone metastases who are receiving ADT. uNTX, sCTX and BAP are markers of bone turnover and bone formation that are suppressed in response to ZA and are associated with the likelihood of development of an SRE. In this study, we propose to determine the duration of suppression of bone turnover (all uNTX, sCTX and BAP) in response to a single dose of ZA in patients with castration resistant prostate cancer metastatic to bone.

Our objectives for this study:

  1. To estimate the proportion of patients with suppression of bone turnover at 12 weeks after administration of a single dose of ZA.
  2. To estimate the distribution of duration of suppression of bone turnover up to 12 weeks after administration of ZA.
  3. To evaluate the frequency of SREs experienced by patients in this population.
  4. To measure quality of life and presence of bone pain over a 12 week period in this patient population by utilizing the Functional Assessment of Cancer Therapy - Bone Pain (FACT-BP) and Brief Pain Inventory (BPI) questionnaires.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

This is a non-randomized observational study

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01062503

Locations
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Ian F Tannock, MD, PhD University Health Network, Toronto
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01062503     History of Changes
Obsolete Identifiers: NCT01016171
Other Study ID Numbers: REB 09-0688-C, PRIT9
Study First Received: February 3, 2010
Last Updated: April 24, 2015
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Cancer
Prostate
metastatic

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Diphosphonates
Zoledronic acid
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 04, 2015