Prostate CancerEarly Phase 1NCT01394042
Prostate Cancer Imaging With Radioactive Tracer and Ultrasound Detector Compared to MRI and ProstaScint
A Early Phase 1 study testing Proxiscan device in people with Prostate Cancer, run by Radiological Associates of Sacramento Medical Group Inc. at 1 site in United States.
Trial summary
This is a small study to determine if probe, similar to an ultrasound probe, can detect prostate cancer more specifically than other imaging studies in patients with a positive prostate cancer biopsy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Proxiscan device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Mar 2012
- Phase
- Early Phase 1
- 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
Who may be able to join
- Primary prostate cancer proven by sextant prostate biopsy
- Transrectal ultrasound (TRUS)-guided prostate biopsy within 6 months of study enrollment
- Sufficient time period to complete imaging protocol and 5-7 day safety followup assessment without other therapeutic intervention
- In the judgement of principal investigator, patient able to provide informed consent and be compliant with protocol requirements
- ECOG status of 0 or 1 Pt > 18 yrs of age
Who cannot join
- Definitive or concomitant therapeutic intervention within the interval of study intervention
- Prior pelvic therapeutic radiation
- Active malignancy or therapy for malignancy with 6 months other than basal or squamous cell carcinoma of the skin
- Pt received radiopharmaceutical which was within 5 half-lives at the time of studying imaging
- Known history of human-anti-murine-antibodies or known allergic reaction to previously received murine based products
Trial locations and contacts
1 site in 1 country.
United States1 site
Roseville PET and Nuclear Imaging Center
Roseville, California, 95661
About this study
Official title: Exploratory Evaluation of a Transrectal Scintigraphic Detector (Proxiscan) for Detection of Primary Prostate Cancer Utilizing a Radiotracer Targeting Prostate Specific Membrane Antigen (PMSA)
This is a small study to determine if probe, similar to an ultrasound probe, can detect prostate cancer more specifically than other imaging studies in patients with a positive prostate cancer biopsy.
- Conditions
- Prostate Cancer
- Being tested
- Proxiscan device
- Keywords
- Biopsy proven primary prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proxiscan deviceDevice
All patients will be imaged with the device
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | All consenting patients will be imaged with the Proxiscan and data compared with MRI, ProstaScint and biopsy data Receives: Device: Proxiscan device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of PSMA antibody (ProstaScint)uptake patterns measured by Proxiscan in comparison with anatomic biopsy reports, conventional SPECT and MRI scans within one month of Proxiscan
Detection of PSMA antibody (ProstaScint) uptake patterns measured by the new transrectal compact gamma camera (Proxiscan) will be compared to the anatomic biopsy reports along with Magnetic Resonance Imaging (MRI) and conventional ProstaScint (Single Photon Emission Computed Tomography) SPECT imaging results. All imaging and biopsy results performed within one month will be used for this investigation
Measured: Within on month of scan and corresponding MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2011 (estimated)
- Study completionMar 2012 (estimated)
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.
- 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radiological Associates of Sacramento Medical Group Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Hybridyne Imaging Technologies
- Investigators
- Benjamin Franc, MD, Principal investigator, Radiological Associates of Sacramento Medical Group Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01394042
- Sponsor's protocol ID
- Proxiscan
- Status last verified
- Jul 2011
- First submitted
- 1 Jul 2011
- Last updated
- 14 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Evaluation of a Transrectal Scintigraphic Detector (Proxiscan) for Detection of Primary Prostate Cancer Utilizing a Radiotracer Targeting Prostate Specific Membrane Antigen (PMSA)
- ClinicalTrials.gov ID
- NCT01394042
- Acronym / sponsor ID
- Proxiscan
- Conditions
- Prostate Cancer
- Keywords
- Biopsy proven primary prostate cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Radiological Associates of Sacramento Medical Group Inc.University, hospital or other
- Collaborators
- Hybridyne Imaging Technologies
- Study start
- Jun 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 14 Jul 2011 (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.
This is a small study to determine if probe, similar to an ultrasound probe, can detect prostate cancer more specifically than other imaging studies in patients with a positive prostate cancer biopsy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | Device: Proxiscan deviceAll consenting patients will be imaged with the Proxiscan and data compared with MRI, ProstaScint and biopsy data |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary prostate cancer proven by sextant prostate biopsy
- Transrectal ultrasound (TRUS)-guided prostate biopsy within 6 months of study enrollment
- Sufficient time period to complete imaging protocol and 5-7 day safety followup assessment without other therapeutic intervention
- In the judgement of principal investigator, patient able to provide informed consent and be compliant with protocol requirements
- ECOG status of 0 or 1 Pt > 18 yrs of age
Key exclusion criteria (5 listed)
- Definitive or concomitant therapeutic intervention within the interval of study intervention
- Prior pelvic therapeutic radiation
- Active malignancy or therapy for malignancy with 6 months other than basal or squamous cell carcinoma of the skin
- Pt received radiopharmaceutical which was within 5 half-lives at the time of studying imaging
- Known history of human-anti-murine-antibodies or known allergic reaction to previously received murine based products
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 |
|---|---|---|
| Proxiscan deviceAll patients will be imaged with the device | Device | No intervention |
Primary outcome
Detection of PSMA antibody (ProstaScint)uptake patterns measured by Proxiscan in comparison with anatomic biopsy reports, conventional SPECT and MRI scans within one month of Proxiscan
Time frame: Within on month of scan and corresponding MRI
Detection of PSMA antibody (ProstaScint) uptake patterns measured by the new transrectal compact gamma camera (Proxiscan) will be compared to the anatomic biopsy reports along with Magnetic Resonance Imaging (MRI) and conventional ProstaScint (Single Photon Emission Computed Tomography) SPECT imaging results. All imaging and biopsy results performed within one month will be used for this investigation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2011.
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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.
Benjamin Franc, MD principal investigator
Radiological Associates of Sacramento Medical Group Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Proxiscan device in people with Prostate Cancer, run by Radiological Associates of Sacramento Medical Group Inc. 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?
The sponsor lists 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Jul 2011. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Detection of PSMA antibody (ProstaScint)uptake patterns measured by Proxiscan in comparison with anatomic biopsy reports, conventional SPECT and MRI scans within one month of Proxiscan (time frame: Within on month of scan and corresponding MRI). 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 14 Jul 2011.