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NCT01205646 · ClinicalTrials.gov registry record · NA
PET Scanning to Evaluate Zoledronate Efficacy in Metastatic Prostate Cancer
A NA study of Prostate Cancer, sponsored by Barbara Ann Karmanos Cancer Institute.
- Completed
- Registry status
- NA
- Development phase
- 11
- Enrollment target
- 2
- Study locations
NCT01205646: Completed NA study of Prostate Cancer, sponsored by Barbara Ann Karmanos Cancer Institute.
NCT01205646 is a NA study of Prostate Cancer that has completed, run by Barbara Ann Karmanos Cancer Institute. The registered enrollment target is 11 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01205646, a NA study of Prostate Cancer, has completed, sponsored by Barbara Ann Karmanos Cancer Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
- 2
- Study locations
Study 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. 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE PET Scan
- DRUG zoledronate therapy
Study Locations (2)
Michigan
- Barbara Ann Karmanos Cancer Institute - Detroit
- Karmanos Cancer Institute Weisberg Cancer Treatment Center - Farmington Hills
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2010-09 |
| Est. Completion | 2015-08 |
| Phase | NA |
What the finished NCT01205646 record still lists
NCT01205646 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which PET Scan is the first listed.
NCT01205646 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT01205646 about?
NCT01205646 is a clinical study titled "PET Scanning to Evaluate Zoledronate Efficacy in 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...
What is the current status of trial NCT01205646?
This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2010-09. Estimated completion is 2015-08.
What conditions does trial NCT01205646 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT01205646?
The interventions under investigation include: PET Scan (DEVICE), zoledronate therapy (DRUG).
Who is sponsoring clinical trial NCT01205646?
This trial is sponsored by Barbara Ann Karmanos Cancer Institute, which has 139 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01205646 being conducted?
This trial has 2 study locations across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01205646's enrollment target sits among peer trials
11 714th of 735 higher than 19 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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