Duration of Suppression of Bone Turnover Following Treatment With Zoledronic Acid in Men With Metastatic Castration Resistant Prostate Cancer (SubDueP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01062503
First received: February 3, 2010
Last updated: June 26, 2012
Last verified: June 2012
  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:

Estimated Enrollment: 50
Study Start Date: January 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (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
  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:

  1. Patients must have histologically confirmed prostate cancer that has become castration resistant.
  2. 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).
  3. Patient has not yet started on BP therapy for metastatic castration resistant prostate cancer.
  4. Renal and hepatic function within the institutional normal range.
  5. Age >/= 18 years
  6. ECOG performance status < 2
  7. Life expectancy > 6 months
  8. Ability to understand and the willingness to sign a written informed consent document.
  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

Contacts
Contact: Anna Dodd 416-946-4501 ext 3176 anna.dodd@uhn.on.ca
Contact: Saroj Niraula, MD 416-946-4501 saroj.niraula@uhn.on.ca

Locations
Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G2M9
Contact: Anna Dodd    416-946-4501 ext 3    anna.dodd@uhn.on.ca   
Principal Investigator: Ian F. Tannock, MD, PhD         
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: Dr. Ian Tannock, University Health Network
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: June 26, 2012
Health Authority: Canada: Research Ethics Board

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

Additional relevant MeSH terms:
Bone Neoplasms
Neoplasm Metastasis
Prostatic Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014