Prostate CancerPCMRINCT00542100
PCMRI - an MRI/TRUS System for the Evaluation of the Prostate
A study testing PCMRI in people with Prostate Cancer, run by TopSpin Medical.
Trial summary
The aim of the clinical study is to evaluate the convenience and efficacy of the PCMRI in the assessment of the prostate in humans. The study cohort will include 50 patients and is designed to be non-comparative to other diagnostic methods. Read more about this study
- Who is it for?
- Ages 25 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- PCMRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Nov 2008
- 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 25 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 45 and 80 years old.
- Presumably Stage 2 and higher prostate carcinoma as determined by the PI.
- At least 6 weeks after the last biopsy session.
- Prior to any PC treatment. for control group:
- Age between 25 and 35 years old.
- No family history of PC.
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- No lower urinary tract symptoms. Exclusion criteria for both groups:
- History of hemorrhoids.
- History of prostetitis
Who cannot join
None listed.
About this study
The aim of the clinical study is to evaluate the convenience and efficacy of the PCMRI in the assessment of the prostate in humans.
The study cohort will include 50 patients and is designed to be non-comparative to other diagnostic methods.
Read the detailed description
Prostate cancer (PC) is the most common male malignancy in the western world. In the U.S. there are approximately 230,000 new diagnoses annually. Each year, 40,000 men with established disease die from PC.
Early detection is possible using prostate specific antigen (PSA) and/or DRE, followed by biopsy if PC is suspected. Biopsy is generally carried out under transrectal ultrasound (TRUS) guidance through the rectum wall. Typically, 6-13 samples from different areas of the prostate are taken in order to cover the entire gland area. Since TRUS cannot accurately detect PC, prostate biopsies, to date, are in fact random biopsies. Furthermore, PSA may be elevated, in patients without PC, leading to as many as 75% of patients undergoing unnecessary TRUS guided biopsy [1,2].
The need for accurate preoperative evaluation of PC, as well as early detection of the tumor has lead to numerous applications of Magnetic Resonance Imaging (MRI) of the prostate.1 The sensitivity and specificity of whole body MRI with pelvic phased-array coils is as low as ~70%. Improved sensitivity is obtained using an endorectal coil where efficacies of ~85% are reported due to the improved signal to noise ratio (SNR) of such coils.2
One of the major limitations of conventional MRI scanners is their cost and limited availability. A portable, hand-held MR scanner capable of detecting PC is thus, of interest. TopSpin has developed a novel MRI based system for prostate imaging in Urology. The primary use of the prostate MRI probe will be diagnosis, staging and guidance of minimally invasive therapy for PC.
The system consists of a miniaturized transrectal MRI probe, incorporating all magnetic field sources and coils. The MRI probe is integrated with and used in conjunction with a TRUS system. The TRUS probe provides prostate gross anatomy and allows the Urologist to select the cross-section(s) of interest within the prostate. The MRI probe provides MRI images of the selected cross-section(s) with improved tissue characterization that enable localizing tumors within the prostate. Fusion of both images has promise of significantly improving the ability to direct biopsies to regions of a much higher likelihood for being malignant. In addition, the system is capable of guiding local treatment such as Cryotherapy or Brachytherapy.
The integrated MRI-TRUS system resembles a state-of-the-art, high-end ultrasound system. The MR-TRUS probe is connected to a cart based console, which houses the electronics hardware required for both MR and ultrasound activation. An investigational device will be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). It will be used in accordance with the approved protocol. Procedures that assure the quality of every aspect of the trial will be implemented.
- Conditions
- Prostate Cancer
- Being tested
- PCMRI
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCMRIDevice
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: PCMRI |
| 2 | Experimental | Not described Receives: Device: PCMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the PCMRI system in PC detection
Measured: one year
Safety of the PCMRI system in PC detection
Measured: one year
Secondary outcomes (4)
Patient comfort
Measured: one year
Compliance
Measured: one year
Ease of use
Measured: one year
Length of the test procedure
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study startNov 2007
- Study completionNov 2008 (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
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TopSpin Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Shmuel Cytron, MD., Principal investigator, Barzilai Medical Center, Ashkelon, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00542100
- Sponsor's protocol ID
- PCL-2-001
- Acronym
- PCMRI
- Status last verified
- Oct 2007
- First submitted
- 7 Oct 2007
- Last updated
- 10 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PCMRI - an MRI/TRUS System for the Evaluation of the Prostate
- ClinicalTrials.gov ID
- NCT00542100
- Acronym / sponsor ID
- PCMRI / PCL-2-001
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- TopSpin MedicalIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Study completion
- Nov 2008 (estimated)
- First posted
- 10 Oct 2007 (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.
The aim of the clinical study is to evaluate the convenience and efficacy of the PCMRI in the assessment of the prostate in humans.
The study cohort will include 50 patients and is designed to be non-comparative to other diagnostic methods.
Detailed description
Prostate cancer (PC) is the most common male malignancy in the western world. In the U.S. there are approximately 230,000 new diagnoses annually. Each year, 40,000 men with established disease die from PC.
Early detection is possible using prostate specific antigen (PSA) and/or DRE, followed by biopsy if PC is suspected. Biopsy is generally carried out under transrectal ultrasound (TRUS) guidance through the rectum wall. Typically, 6-13 samples from different areas of the prostate are taken in order to cover the entire gland area. Since TRUS cannot accurately detect PC, prostate biopsies, to date, are in fact random biopsies. Furthermore, PSA may be elevated, in patients without PC, leading to as many as 75% of patients undergoing unnecessary TRUS guided biopsy [1,2].
The need for accurate preoperative evaluation of PC, as well as early detection of the tumor has lead to numerous applications of Magnetic Resonance Imaging (MRI) of the prostate.1 The sensitivity and specificity of whole body MRI with pelvic phased-array coils is as low as ~70%. Improved sensitivity is obtained using an endorectal coil where efficacies of ~85% are reported due to the improved signal to noise ratio (SNR) of such coils.2
One of the major limitations of conventional MRI scanners is their cost and limited availability. A portable, hand-held MR scanner capable of detecting PC is thus, of interest. TopSpin has developed a novel MRI based system for prostate imaging in Urology. The primary use of the prostate MRI probe will be diagnosis, staging and guidance of minimally invasive therapy for PC.
The system consists of a miniaturized transrectal MRI probe, incorporating all magnetic field sources and coils. The MRI probe is integrated with and used in conjunction with a TRUS system. The TRUS probe provides prostate gross anatomy and allows the Urologist to select the cross-section(s) of interest within the prostate. The MRI probe provides MRI images of the selected cross-section(s) with improved tissue characterization that enable localizing tumors within the prostate. Fusion of both images has promise of significantly improving the ability to direct biopsies to regions of a much higher likelihood for being malignant. In addition, the system is capable of guiding local treatment such as Cryotherapy or Brachytherapy.
The integrated MRI-TRUS system resembles a state-of-the-art, high-end ultrasound system. The MR-TRUS probe is connected to a cart based console, which houses the electronics hardware required for both MR and ultrasound activation. An investigational device will be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). It will be used in accordance with the approved protocol. Procedures that assure the quality of every aspect of the trial will be implemented.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: PCMRI |
| 2 | Experimental | Device: PCMRI |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age between 45 and 80 years old.
- Presumably Stage 2 and higher prostate carcinoma as determined by the PI.
- At least 6 weeks after the last biopsy session.
- Prior to any PC treatment. for control group:
- Age between 25 and 35 years old.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PCMRI | Device | 1, 2 |
Primary outcome
Efficacy of the PCMRI system in PC detection
Time frame: one year
Safety of the PCMRI system in PC detection
Time frame: one year
4 secondary outcomes
Patient comfort
Time frame: one year
Compliance
Time frame: one year
Ease of use
Time frame: one year
Length of the test procedure
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2007.
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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.
Shmuel Cytron, MD. principal investigator
Barzilai Medical Center, Ashkelon, Israel
Questions about this trial
What is this clinical trial studying?
A study testing PCMRI in people with Prostate Cancer, run by TopSpin Medical.
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 9 inclusion and 0 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 10 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Efficacy of the PCMRI system in PC detection (time frame: one year). The study lists 2 primary outcomes in all. 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 10 Oct 2007.