Urologic NeoplasmsPhase 2NCT00226954
Zoledronic Acid With Intermittent Hormonal Therapy in Patients With Prostate Cancer
A Phase 2 study testing zoledronic acid in people with Urologic Neoplasms, run by Stanford University at 1 site in United States.
Trial summary
Primary: To determine the duration of use of zoledronic acid in improving Bone mineral density in patients with prostate cancer who are on hormones intermittently. Secondary Objectives: To describe the safety and tolerability at this dose and schedule Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urologic Neoplasms
- What is being tested?
- zoledronic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Feb 2009
- Phase
- Phase 2
- 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
Inclusion Criteria:Patients: Who are 18 years of age and older Who have histologically documented adenocarcinoma of prostate Who are currently receiving LHRH agonists KPS greater than 80%Life expectancy greater than 6 months Provide written consent pursuant to regulatory requirements prior to initiation of study procedure Exclusion Criteria:Exclusion Criteria: Patients: Any patient requiring continuous LHRH Any patient who has had an orchiectomy Any patient with painful bone metastases Who have received chemotherapy for prostate cancer Who have a abnormal serum creatine >2.5 Receiving any investigational drug within the last 28 days Severe uncontrolled infection, diabetes, cardiac disease Patients with fragility fractures, hyperparathyroidism, Pagets renal osteodystrophy will be excluded History of non compliance to medical regimens or unwillingness to return for medical visits
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Primary:
To determine the duration of use of zoledronic acid in improving Bone mineral density in patients with prostate cancer who are on hormones intermittently.
Secondary Objectives:
To describe the safety and tolerability at this dose and schedule
- Conditions
- Urologic Neoplasms
- Being tested
- zoledronic acid
- Medical subject headings
- Urologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zoledronic acidDrug
| Study group | Role | What they receive |
|---|---|---|
| Zoledronic Acid with Intermittent Hormonal Therapy | Experimental | Not described Receives: Drug: zoledronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the duration of use of zoledronic acid in improving Bone mineral density in patients with prostate cancer who are on hormones intermittently.
Secondary outcomes (1)
To describe the safety and tolerability at this dose and schedule
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2005 (estimated)
- Study startMar 2003
- Primary completionNov 2007
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Sandy Srinivas, Stanford University
- Investigators
- Dr. Sandy Srinivas, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226954
- Sponsor's protocol ID
- PROS0001
- Other IDs
- 78869, NCT00226954, PROS0001
- Status last verified
- Mar 2020
- First submitted
- 13 Sep 2005
- Last updated
- 18 Mar 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zoledronic Acid With Intermittent Hormonal Therapy in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT00226954
- Acronym / sponsor ID
- PROS0001
- Conditions
- Urologic Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Mar 2003
- Primary completion
- Nov 2007 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 27 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.
Primary:
To determine the duration of use of zoledronic acid in improving Bone mineral density in patients with prostate cancer who are on hormones intermittently.
Secondary Objectives:
To describe the safety and tolerability at this dose and schedule
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zoledronic Acid with Intermittent Hormonal Therapy | Experimental | Drug: zoledronic acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 acid | Drug | Zoledronic Acid with Intermittent Hormonal Therapy |
Primary outcome
To determine the duration of use of zoledronic acid in improving Bone mineral density in patients with prostate cancer who are on hormones intermittently.
1 secondary outcome
To describe the safety and tolerability at this dose and schedule
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
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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.
Dr. Sandy Srinivas principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing zoledronic acid in people with Urologic Neoplasms, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 18 Mar 2020. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
To determine the duration of use of zoledronic acid in improving Bone mineral density in patients with prostate cancer who are on hormones intermittently.. 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 18 Mar 2020.