Prostate CancerNCT01205646
PET Scanning to Evaluate Zoledronate Efficacy in Metastatic Prostate Cancer
A study testing zoledronate therapy and PET Scan in people with Prostate Cancer, run by Barbara Ann Karmanos Cancer Institute at 2 sites in United States.
Trial summary
The primary goal for this trial is to assess the change in PET scans with the administration of zoledronate (bisphosphonate) therapy in patients with metastatic prostate cancer. It has been established that zoledronate therapy may play a role in delaying and reducing the incidence of skeletal events. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- zoledronate therapy and PET Scan
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2010to Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histological diagnosis of prostate cancer
- Evidence of metastatic disease by radiologic criteria
- Bone scan within 4 weeks of starting therapy
- Creatinine within 2 weeks of registration, calculated creatinine clearance > 60ml/min.
- Minimum life expectancy of 6 months
- Willingness to have pre-therapy PET scans performed within 2 weeks after registration and post therapy PET scan performed within 1 week after dose of Zometa (a total of 3 PET scans required)
Show all 17Show fewer
- Calculated creatinine clearance > 50ml/min.
- No prior Zoledronate therapy
- Patients must have disease progression despite testosterone suppression (level<50ng/ml); progression can be by rising PSA ( at least 2 values at least 2 weeks apart) or by new lesions on scans or progression of existing lesions on CT scan.
- No concomitant systemic therapy for metastatic prostate cancer is allowed except LHRH analogue should be continued if necessary to maintain testosterone suppression.
- No concomitant radiation therapy
- Prior RT is allowed if completed at least 2 weeks prior to registration.
- Presence of measurable or evaluable disease
- If RT has been administered, disease outside the RT port is required.
- Willingness to sign informed consent.
- Registration and willingness to sign informed consent for separate PET protocol 2335 that describes the PET scan procedure.
- Patients must have good oral hygiene which includes having a recent dental evaluation
Who cannot join
- Patients who are unable to swallow
- Patients with dental cavities that are likely to need dental extraction or root canal treatment as management
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
Karmanos Cancer Institute Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334
About this study
Official title: Pilot Trial to Evaluate Change in Positron Emission Tomography Scanning (PET) as a Surrogate for Zoledronate (Zometa) Efficacy in Patients With Metastatic Prostate Cancer
The primary goal for this trial is to assess the change in PET scans with the administration of zoledronate (bisphosphonate) therapy in patients with metastatic prostate cancer. It has been established that zoledronate therapy may play a role in delaying and reducing the incidence of skeletal events. Researchers propose to evaluate the change in the uptake value of FMAU PET scan after the zoledronate therapy. It has been demonstrated that FMAU PET scans can successfully demonstrate and detect bony metastatic sites in prostate cancer.
In addition, investigators would like to evaluate the change in the level of the prostate-specific antigen (PSA) in the patient as well as outcome of bone scans.
- Conditions
- Prostate Cancer
- Being tested
- zoledronate therapy, PET Scan
- Keywords
- prostate cancer, metastatic, zoledronate, zometa
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zoledronate therapyDrug
Also called Zometa
Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function.
PET ScanDevice
2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration.
| Study group | Role | What they receive |
|---|---|---|
| Zometa & PET Scans | Experimental | Zoledronate therapy \& PET scan ;2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Receives: Drug: zoledronate therapy; Device: PET Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET Response Rate in Metastatic Prostate Cancer Patients Treated With Zoledronate Therapy.
PET response rate was pre-defined in Section 5.0 of the protocol based on the magnitude of change in the mean standardized uptake value (SUVmean), which is measured at each PET scan. Specifically, a decline in SUVmean of at least 15% pre/post Zometa was taken as evidence of a "PET response". Per the protocol, Scan 2 was used as the pre-Zometa measure of SUVmean, and Scan 3 (1-2 weeks later) was used as the post-Zometa measure of SUVmean.
Measured: Within 3 weeks
Secondary outcomes (3)
The Change in PSA After Zoledronate Therapy
The change in PSA after zoledronate therapy using per cent change.
Measured: Four weeks after initiating Zoledronate therapy
Change in Bone Scans
Change in bone scans using per cent change in SUVmax.
Measured: Four weeks after initiating zoledronate therapy
Changes in Bone Turnover Markers
Changes in bone turnover markers using per cent change of BSAP and NTx
Measured: Four weeks after initiating zoledronte therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionAug 2013
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Ulka Vaishampayan, Barbara Ann Karmanos Cancer Institute
- Investigators
- Ulka N. Vaishampayan, M.D., Principal investigator, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01205646
- Sponsor's protocol ID
- WSU 2006-066
- Status last verified
- Apr 2019
- First submitted
- 17 Sep 2010
- Last updated
- 12 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial to Evaluate Change in Positron Emission Tomography Scanning (PET) as a Surrogate for Zoledronate (Zometa) Efficacy in Patients With Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT01205646
- Acronym / sponsor ID
- WSU 2006-066
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, metastatic, zoledronate, zometa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Sep 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 20 Sep 2010 (estimated)
- Results
- Posted 6 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goal for this trial is to assess the change in PET scans with the administration of zoledronate (bisphosphonate) therapy in patients with metastatic prostate cancer. It has been established that zoledronate therapy may play a role in delaying and reducing the incidence of skeletal events. Researchers propose to evaluate the change in the uptake value of FMAU PET scan after the zoledronate therapy. It has been demonstrated that FMAU PET scans can successfully demonstrate and detect bony metastatic sites in prostate cancer.
In addition, investigators would like to evaluate the change in the level of the prostate-specific antigen (PSA) in the patient as well as outcome of bone scans.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zometa & PET Scans | Experimental | Drug: zoledronate therapy, Device: PET ScanZoledronate therapy \& PET scan ;2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- Histological diagnosis of prostate cancer
- Evidence of metastatic disease by radiologic criteria
- Bone scan within 4 weeks of starting therapy
- Creatinine within 2 weeks of registration, calculated creatinine clearance > 60ml/min.
- Minimum life expectancy of 6 months
Key exclusion criteria (2 listed)
- Patients who are unable to swallow
- Patients with dental cavities that are likely to need dental extraction or root canal treatment as management
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 |
|---|---|---|
| zoledronate therapyAlso: ZometaZometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function. | Drug | Zometa & PET Scans |
| PET Scan2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration. | Device | Zometa & PET Scans |
Primary outcome
PET Response Rate in Metastatic Prostate Cancer Patients Treated With Zoledronate Therapy.
Time frame: Within 3 weeks
PET response rate was pre-defined in Section 5.0 of the protocol based on the magnitude of change in the mean standardized uptake value (SUVmean), which is measured at each PET scan. Specifically, a decline in SUVmean of at least 15% pre/post Zometa was taken as evidence of a "PET response". Per the protocol, Scan 2 was used as the pre-Zometa measure of SUVmean, and Scan 3 (1-2 weeks later) was used as the post-Zometa measure of SUVmean.
3 secondary outcomes
The Change in PSA After Zoledronate Therapy
Time frame: Four weeks after initiating Zoledronate therapy
Change in Bone Scans
Time frame: Four weeks after initiating zoledronate therapy
Changes in Bone Turnover Markers
Time frame: Four weeks after initiating zoledronte therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ulka N. Vaishampayan, M.D. principal investigator
Barbara Ann Karmanos Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing zoledronate therapy and PET Scan in people with Prostate Cancer, run by Barbara Ann Karmanos Cancer Institute at 2 sites 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?
The sponsor lists 17 inclusion and 2 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 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
PET Response Rate in Metastatic Prostate Cancer Patients Treated With Zoledronate Therapy. (time frame: Within 3 weeks). 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 12 Apr 2019.