Prostate CancerNCT00199537
Bone Loss in Men on Androgen Blockade as Adjuvant Therapy for Prostate Cancer
An observational study of Prostate Cancer and Bone Loss, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Patients with advanced prostate cancer undergoing adjuvant treatment with androgen blockade will be followed over a 1 year interval to assess the effects of this treatment on bone metabolism. It is expected that men undergoing androgen blockade will experience accelerated bone loss. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Cancer, Bone Loss
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2005to Feb 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men with Prostate Cancer undergoing continued treatment with leuteinizing hormone-releasing hormone [LHRH] therapy
Who may be able to join
- Men
- Age of 40 years or greater
- Diagnosis of advanced prostate cancer (ie: prostate-specific antigen [PSA] less than 25 ug/L and undergoing continued treatment with leuteinizing hormone-releasing hormone [LHRH] therapy)
- Willing and able to consent
Who cannot join
- Metastatic disease to bone
- Medications affecting bone turnover (bisphosphonate, steroids, anticonvulsant)
- Renal failure (serum creatinine > 200 umol/L)
- Co-morbidity factors affecting bone density (ie: Paget's, rheumatoid arthritis)
- Factors affecting ability to perform the bone density tests using femoral head measurements (ie: bilateral hip arthroplasty)
- Cancer other than skin, except when, in the investigators' opinion, it is determined to be appropriate and not adversely affect the outcome of the trial
- Gastrointestinal (GI) pathology (eg. malabsorption syndrome)
- Parathyroid disease
Trial locations and contacts
1 site in 1 country.
Canada1 site
Urology Clinic & Prostate Centre, St. Joseph's Hospital, St. Joseph's Health Care London
London, Ontario, N6A 4V2
About this study
Patients with advanced prostate cancer undergoing adjuvant treatment with androgen blockade will be followed over a 1 year interval to assess the effects of this treatment on bone metabolism. It is expected that men undergoing androgen blockade will experience accelerated bone loss.
- Conditions
- Prostate Cancer, Bone Loss
- Medical subject headings
- Prostatic Neoplasms, Bone Diseases, Metabolic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Lawson Health Research Institute Internal Review Fund, University of Western Ontario, Canada
- Investigators
- Hassan Razvi, MD, FRCSC, Principal investigator, Urology, St. Joseph's Hospital, University of Western Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199537
- Sponsor's protocol ID
- R-05-055
- Other IDs
- Lawson IRF-071-04, UWO ADF SG06-02
- Status last verified
- Jul 2008
- First submitted
- 13 Sep 2005
- Last updated
- 29 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Loss in Men on Androgen Blockade as Adjuvant Therapy for Prostate Cancer
- ClinicalTrials.gov ID
- NCT00199537
- Acronym / sponsor ID
- R-05-055
- Conditions
- Prostate Cancer, Bone Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Lawson Health Research Institute Internal Review Fund, University of Western Ontario, Canada
- Study start
- Feb 2005
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with advanced prostate cancer undergoing adjuvant treatment with androgen blockade will be followed over a 1 year interval to assess the effects of this treatment on bone metabolism. It is expected that men undergoing androgen blockade will experience accelerated bone loss.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men with Prostate Cancer undergoing continued treatment with leuteinizing hormone-releasing hormone [LHRH] therapy
Key inclusion criteria (4 listed)
- Men
- Age of 40 years or greater
- Diagnosis of advanced prostate cancer (ie: prostate-specific antigen [PSA] less than 25 ug/L and undergoing continued treatment with leuteinizing hormone-releasing hormone [LHRH] therapy)
- Willing and able to consent
Key exclusion criteria (8 listed)
- Metastatic disease to bone
- Medications affecting bone turnover (bisphosphonate, steroids, anticonvulsant)
- Renal failure (serum creatinine > 200 umol/L)
- Co-morbidity factors affecting bone density (ie: Paget's, rheumatoid arthritis)
- Factors affecting ability to perform the bone density tests using femoral head measurements (ie: bilateral hip arthroplasty)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hassan Razvi, MD, FRCSC principal investigator
Urology, St. Joseph's Hospital, University of Western Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Bone Loss, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2008.