Prostate CancerProxiScanNCT02786459
Detection and Localization of Carcinoma Using High Resolution Transrectal Imaging - Proof of Concept Study
A study testing ProxiScan, Magnetic Resonance Imaging and SPECT-CT in people with Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
An exploratory, feasibility and proof-of-concept study to evaluate the capability of a rectal probe scintigraphy device (ProxiScanTM) to detect PSMA specific radiopharmaceutical agent (ProstaScint®; as a surrogate marker for prostate cancer) in patients who have undergone a radical prostatectomy for their disease… Read more about this study
- Who is it for?
- Ages 30 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- ProxiScan, Magnetic Resonance Imaging and SPECT-CT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2016to Apr 2019
- Phase
- Interventional
- 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 30 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Group 1: Rising PSA (biochemical failure) following radical prostatectomy. Group 2: Rising PSA (>10ng/ml) and/or abnormal digital rectal exam suspicious for prostate cancer. Previously negative prostate biopsies.
- Group 3: Scheduled biopsy for known PCa (patient on AS). At least 1 previously positive prostate biopsy for adenocarcinoma of the prostate.
- Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- Sufficient time period to complete the imaging protocol and 7 to 9 day safety follow-up assessment without therapeutic intervention.
- Patient is judged by the Investigator to have the initiative and means to provide written consent and be compliant with the protocol and be able and commits to make the required study visits.
- Ambulatory with ECOG performance status of 0 or 1 (see appendix section).
- Patient is between 35 and 75 years of age.
Who cannot join
- The presence of any of the following will exclude a patient from study enrollment:
- Patient or physician plans definitive concomitant chemotherapy, therapeutic radiation treatment, biologic treatment and/or local ablative treatment for cancer within the interval of study participation.
- Patients with pacemakers, neurostimulators, and foreign metal bodies will be excluded as they will be unable to undergo an MRI and SPECT-CT.
- Prior history of murine antibody infusion, patients who are hypersensitive to products of murine origin or indium-111 chloride.
- Prior therapeutic pelvic irradiation.
- Recent prostate biopsy, within 1 month of study enrollment.
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- Patient with contraindications to TRUS-guided prostate biopsy (continuous need for anti-coagulation, no rectum, etc.)
- Clinical evidence of prostatitis, or other benign prostate gland abnormality, that would explain elevated PSA and/or (digital rectal exam) DRE findings.
- Active malignancy or therapy for malignancy within 6 months, other than basal or squamous cell carcinoma of the skin.
- Patient received a radiopharmaceutical which was within 5 physical half-lives at the time of study imaging.
- Severe psychiatric or medical illness that may interfere with compliance with the study protocol or follow-up as deemed by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
An exploratory, feasibility and proof-of-concept study to evaluate the capability of a rectal probe scintigraphy device (ProxiScanTM) to detect PSMA specific radiopharmaceutical agent (ProstaScint®; as a surrogate marker for prostate cancer) in patients who have undergone a radical prostatectomy for their disease, patients with multiple negative prostate biopsies and patients with known primary prostate cancer. Developed by Hybridyne Imaging Technologies, Inc. ProxiScanTM is a small cadmium zinc telluride (CST)-based compact gamma camera. It is the same size as a trans-rectal ultrasound (TRUS), currently used for prostate biopsy guidance. Men with multiple positive biopsies will be considered controls. Prostate cancer sextant biopsy histology results will be correlated with ProxiScanTM, TRUS, MRI and SPECT/CT. The investigators hypothesize that it will be safe and feasible to utilize a rectal probe scintigraphy (ProxiScanTM) to detect PSMA specific ProstaScint®, thus identifying and localizing the tumour sites within the prostate and surrounding areas.
- Conditions
- Prostate Cancer
- Being tested
- ProxiScan, Magnetic Resonance Imaging, SPECT-CT
- Keywords
- Prostate, Local Recurrence, Radical Prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProxiScanDevice
ProxiScan probe will be coupled with ProstaScint (a radioactive tracer) and used to perform imaging to detect small lesions in the pelvis that will otherwise be hard to detect with conventional imaging modalities.
Magnetic Resonance ImagingDevice
Used as a comparative to ProxiScan.
SPECT-CTDevice
Used as a comparative to ProxiScan.
| Study group | Role | What they receive |
|---|---|---|
| Post Radical Prostatectomy | Experimental | Up to n=30 evaluable male patients, between ages 30-75, who were previously diagnosed with PCa, have undergone a RP at least 6 months before imaging and who experience rising PSA (biochemical failure). The RP group (n=30) will be stratified into PSA subgroups <0.005, 0.005-<0.2, >0.2.
Intervention: men will be imaged with ProxiScan, SPECT-CT and MRI. Receives: Device: ProxiScan; Device: Magnetic Resonance Imaging; Device: SPECT-CT |
| Active Surveillance | Active comparator | Up to n=10 men, between ages 30-75, on active surveillance with known prostate adenocarcinoma diagnosis and multiple positive biopsies.
Intervention: men will be imaged with ProxiScan, SPECT-CT and MRI, and also undergo a TRUS biopsy. Receives: Device: ProxiScan; Device: Magnetic Resonance Imaging; Device: SPECT-CT |
| Multiple Negative Biopsies | Experimental | Up to n=20 men, between ages 30-75, who have previously undergone one/or multiple negative biopsies, with elevated PSA (≥4 ng/mL) and/or an abnormal digital rectal exam suspicious for prostate cancer with a planned sextant prostate biopsy but who do not have a definitive PCa diagnosis.
Intervention: men will be imaged with ProxiScan, SPECT-CT and MRI, and also undergo a TRUS biopsy. Receives: Device: ProxiScan; Device: Magnetic Resonance Imaging; Device: SPECT-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor localization.
Identification of tumour and/or tumour recurrence in the pelvis with imaging.
Measured: Within 2 days of imaging.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2018
- Study completionApr 2019
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Hybridyne Imaging Technologies Inc, Aytu BioPharma, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02786459
- Sponsor's protocol ID
- 15-8723-C
- Acronym
- ProxiScan
- Status last verified
- May 2019
- First submitted
- 4 May 2016
- Last updated
- 3 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection and Localization of Carcinoma Using High Resolution Transrectal Imaging - Proof of Concept Study
- ClinicalTrials.gov ID
- NCT02786459
- Acronym / sponsor ID
- ProxiScan / 15-8723-C
- Conditions
- Prostate Cancer
- Keywords
- Prostate, Local Recurrence, Radical Prostatectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Hybridyne Imaging Technologies Inc, Aytu BioPharma, Inc.
- Study start
- Apr 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 1 Jun 2016 (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.
An exploratory, feasibility and proof-of-concept study to evaluate the capability of a rectal probe scintigraphy device (ProxiScanTM) to detect PSMA specific radiopharmaceutical agent (ProstaScint®; as a surrogate marker for prostate cancer) in patients who have undergone a radical prostatectomy for their disease, patients with multiple negative prostate biopsies and patients with known primary prostate cancer. Developed by Hybridyne Imaging Technologies, Inc. ProxiScanTM is a small cadmium zinc telluride (CST)-based compact gamma camera. It is the same size as a trans-rectal ultrasound (TRUS), currently used for prostate biopsy guidance. Men with multiple positive biopsies will be considered controls. Prostate cancer sextant biopsy histology results will be correlated with ProxiScanTM, TRUS, MRI and SPECT/CT. The investigators hypothesize that it will be safe and feasible to utilize a rectal probe scintigraphy (ProxiScanTM) to detect PSMA specific ProstaScint®, thus identifying and localizing the tumour sites within the prostate and surrounding areas.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Post Radical Prostatectomy | Experimental | Device: ProxiScan, Device: Magnetic Resonance Imaging, Device: SPECT-CTUp to n=30 evaluable male patients, between ages 30-75, who were previously diagnosed with PCa, have undergone a RP at least 6 months before imaging and who experience rising PSA (biochemical failure). The RP group (n=30) will be stratified into PSA subgroups <0.005, 0.005-<0.2, >0.2. Intervention: men will be imaged with ProxiScan, SPECT-CT and MRI. |
| Active Surveillance | Active comparator | Device: ProxiScan, Device: Magnetic Resonance Imaging, Device: SPECT-CTUp to n=10 men, between ages 30-75, on active surveillance with known prostate adenocarcinoma diagnosis and multiple positive biopsies. Intervention: men will be imaged with ProxiScan, SPECT-CT and MRI, and also undergo a TRUS biopsy. |
| Multiple Negative Biopsies | Experimental | Device: ProxiScan, Device: Magnetic Resonance Imaging, Device: SPECT-CTUp to n=20 men, between ages 30-75, who have previously undergone one/or multiple negative biopsies, with elevated PSA (≥4 ng/mL) and/or an abnormal digital rectal exam suspicious for prostate cancer with a planned sextant prostate biopsy but who do not have a definitive PCa diagnosis. Intervention: men will be imaged with ProxiScan, SPECT-CT and MRI, and also undergo a TRUS biopsy. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Group 1: Rising PSA (biochemical failure) following radical prostatectomy. Group 2: Rising PSA (>10ng/ml) and/or abnormal digital rectal exam suspicious for prostate cancer. Previously negative prostate biopsies.
- Group 3: Scheduled biopsy for known PCa (patient on AS). At least 1 previously positive prostate biopsy for adenocarcinoma of the prostate.
- Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- Sufficient time period to complete the imaging protocol and 7 to 9 day safety follow-up assessment without therapeutic intervention.
- Patient is judged by the Investigator to have the initiative and means to provide written consent and be compliant with the protocol and be able and commits to make the required study visits.
Key exclusion criteria (11 listed)
- Patient or physician plans definitive concomitant chemotherapy, therapeutic radiation treatment, biologic treatment and/or local ablative treatment for cancer within the interval of study participation.
- Patients with pacemakers, neurostimulators, and foreign metal bodies will be excluded as they will be unable to undergo an MRI and SPECT-CT.
- Prior history of murine antibody infusion, patients who are hypersensitive to products of murine origin or indium-111 chloride.
- Prior therapeutic pelvic irradiation.
- Recent prostate biopsy, within 1 month of study enrollment.
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 |
|---|---|---|
| ProxiScanProxiScan probe will be coupled with ProstaScint (a radioactive tracer) and used to perform imaging to detect small lesions in the pelvis that will otherwise be hard to detect with conventional imaging modalities. | Device | Active Surveillance, Multiple Negative Biopsies, Post Radical Prostatectomy |
| Magnetic Resonance ImagingUsed as a comparative to ProxiScan. | Device | Active Surveillance, Multiple Negative Biopsies, Post Radical Prostatectomy |
| SPECT-CTUsed as a comparative to ProxiScan. | Device | Active Surveillance, Multiple Negative Biopsies, Post Radical Prostatectomy |
Primary outcome
Tumor localization.
Time frame: Within 2 days of imaging.
Identification of tumour and/or tumour recurrence in the pelvis with imaging.
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 3 Jun 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProxiScan, Magnetic Resonance Imaging and SPECT-CT in people with Prostate Cancer, 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 7 inclusion and 11 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 3 Jun 2019. 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?
Tumor localization. (time frame: Within 2 days of imaging.). 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 3 Jun 2019.