Metastatic Prostate CancerSubDuePNCT01062503
Duration of Suppression of Bone Turnover Following Treatment With Zoledronic Acid in Men With Metastatic CRPC
An observational study of Metastatic Prostate Cancer and Bone Metastasis, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Prostate Cancer, Bone Metastasis
- What is being tested?
- Zoledronic acid
- Type of treatment
- Injection or infusion
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2010to Jun 2014
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: This is a non-randomized observational study
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Duration of Suppression of Bone Turnover Following Treatment With Zoledronic Acid in Men With Metastatic Castration Resistant Prostate Cancer
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.
Read the 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:
- To estimate the proportion of patients with suppression of bone turnover at 12 weeks after administration of a single dose of ZA.
- To estimate the distribution of duration of suppression of bone turnover up to 12 weeks after administration of ZA.
- To evaluate the frequency of SREs experienced by patients in this population.
- 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.
- Conditions
- Metastatic Prostate Cancer, Bone Metastasis
- Being tested
- Zoledronic acid
- Keywords
- Cancer, Prostate, metastatic
- Medical subject headings
- Prostatic Neoplasms, Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic acidDrug
Also called Zometa
ZA at a dose of 4mg will be administered by intravenous infusion over 15 minutes in at least 100mls of saline
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients given single dose of Zoledronic Acid 4mg IV
Measured: baseline
Secondary outcomes (3)
Brief Pain Inventory Location Questionnaire
Measured: Baseline, Q6weeks, Q12weeks, 26weeks
FACT-BP Quality of Life Questionnaire
Measured: Baseline, Q6weeks, Q12weeks, 26weeks
We will monitor for uNTX, sCTX, BAP (fasting morning sample)
Measured: Baseline, Q3wks, Q6wks, Q9wks Q12wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ian F Tannock, MD, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062503
- Sponsor's protocol ID
- REB 09-0688-C
- Other IDs
- PRIT9
- Acronym
- SubDueP
- Status last verified
- Apr 2015
- First submitted
- 3 Feb 2010
- Last updated
- 27 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Suppression of Bone Turnover Following Treatment With Zoledronic Acid in Men With Metastatic Castration Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT01062503
- Acronym / sponsor ID
- SubDueP / REB 09-0688-C
- Conditions
- Metastatic Prostate Cancer, Bone Metastasis
- Keywords
- Cancer, Prostate, metastatic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 4 Feb 2010 (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.
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.
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:
- To estimate the proportion of patients with suppression of bone turnover at 12 weeks after administration of a single dose of ZA.
- To estimate the distribution of duration of suppression of bone turnover up to 12 weeks after administration of ZA.
- To evaluate the frequency of SREs experienced by patients in this population.
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a non-randomized observational study
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoledronic acidAlso: ZometaZA at a dose of 4mg will be administered by intravenous infusion over 15 minutes in at least 100mls of saline | Drug | – |
Primary outcome
Patients given single dose of Zoledronic Acid 4mg IV
Time frame: baseline
3 secondary outcomes
Brief Pain Inventory Location Questionnaire
Time frame: Baseline, Q6weeks, Q12weeks, 26weeks
FACT-BP Quality of Life Questionnaire
Time frame: Baseline, Q6weeks, Q12weeks, 26weeks
We will monitor for uNTX, sCTX, BAP (fasting morning sample)
Time frame: Baseline, Q3wks, Q6wks, Q9wks Q12wks
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 27 Apr 2015.
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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.
Ian F Tannock, MD, PhD principal investigator
University Health Network, Toronto
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 Metastatic Prostate Cancer and Bone Metastasis, run by University Health Network, Toronto 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 8 inclusion and 6 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 27 Apr 2015. 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.
What does the primary outcome measure?
Patients given single dose of Zoledronic Acid 4mg IV (time frame: baseline). It is what the study was designed to measure, not a finding.
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 27 Apr 2015.