Prostatic NeoplasmsPROSITNCT03428087
Prostate Impendance Test Project
An observational study of Prostatic Neoplasms and PSA, run by University of Pisa at 1 site in Italy.
Trial summary
Impedance-based analysis could provide an adequate response to the need to identify a safe and reliable tool alternative to bioptic diagnosis. Patients who are candidates for prostate biopsy as suffering from urinary symptoms accompanied by clinical suspicions such as high total PSA value and / or presence of prostate… Read more about this study
- Who is it for?
- Ages 45 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostatic Neoplasms, PSA, Prostatic Biopsy
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2017to 30 Jun 2018
- Phase
- Observational
- 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 45 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: In order to build a two-pronged analysis of areas of confidence and tolerance, it is necessary to examine a fair number of potentially ill subjects and compare them with healthy subjects (controls). Past experiences indicate that about 100 measurements in each grop can create a sufficiently dense and significant cluster to be able to trace besides the "boundries" of 50%, 75%, and 95% even a 95% confidence center of small size suitable to establish an adequate significance.
Who may be able to join
- age> 45 years
- up of total PSA values beyond the normal range (> 4 ng / ml)
- presence or absence of suspicious prostate nodule
Who cannot join
- previous history of cancer
- BMI>30
- patients with previous diagnosis of PIN HG at prostate core biopsy or in active surveillance
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
AOUP Ospedale cisanello
Pisa, Tuscany, 56124
Tommaso Di Vico, MD, 3393642655, urologiapisa@gmail.com
About this study
Official title: Prostate Impendance Test Project (PROS.IT) in Prostate Cancer Diagnosis: a Cross-sectional Observational Study
Impedance-based analysis could provide an adequate response to the need to identify a safe and reliable tool alternative to bioptic diagnosis. Patients who are candidates for prostate biopsy as suffering from urinary symptoms accompanied by clinical suspicions such as high total PSA value and / or presence of prostate nodule and / or evidence of obvious lesion to available imaging methods will be subjected to impedance measurement. Aim of this study is to be able to structure a bivariate analysis of the distribution of impedances detected in patients with neoplasia in order to detect test median reference values.
- Conditions
- Prostatic Neoplasms, PSA, Prostatic Biopsy, Impedance Test
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients undergoing prostatic biopsy | Patients who are candidates for prostate biopsy as suffering from urinary symptoms accompanied by clinical suspicions such as high total PSA value and / or presence of prostate nodule and / or evidence of obvious lesion to available imaging methods. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impedance-based analysis based on phase-sensitive sensors
Measured: during rectal examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start1 Jul 2017
- Primary completion2 Feb 2018
- Study completion30 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Riccardo Bartoletti, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428087
- Sponsor's protocol ID
- 151/2016
- Acronym
- PROSIT
- Status last verified
- Feb 2018
- First submitted
- 3 Feb 2018
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Impendance Test Project (PROS.IT) in Prostate Cancer Diagnosis: a Cross-sectional Observational Study
- ClinicalTrials.gov ID
- NCT03428087
- Acronym / sponsor ID
- PROSIT / 151/2016
- Conditions
- Prostatic Neoplasms, PSA, Prostatic Biopsy, Impedance Test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 2 Feb 2018 (actual)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 9 Feb 2018 (actual)
- 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.
Impedance-based analysis could provide an adequate response to the need to identify a safe and reliable tool alternative to bioptic diagnosis. Patients who are candidates for prostate biopsy as suffering from urinary symptoms accompanied by clinical suspicions such as high total PSA value and / or presence of prostate nodule and / or evidence of obvious lesion to available imaging methods will be subjected to impedance measurement. Aim of this study is to be able to structure a bivariate analysis of the distribution of impedances detected in patients with neoplasia in order to detect test median reference values.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients undergoing prostatic biopsy | – | –Patients who are candidates for prostate biopsy as suffering from urinary symptoms accompanied by clinical suspicions such as high total PSA value and / or presence of prostate nodule and / or evidence of obvious lesion to available imaging methods. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In order to build a two-pronged analysis of areas of confidence and tolerance, it is necessary to examine a fair number of potentially ill subjects and compare them with healthy subjects (controls). Past experiences indicate that about 100 measurements in each grop can create a sufficiently dense and significant cluster to be able to trace besides the "boundries" of 50%, 75%, and 95% even a 95% confidence center of small size suitable to establish an adequate significance.
Key inclusion criteria (3 listed)
- age> 45 years
- up of total PSA values beyond the normal range (> 4 ng / ml)
- presence or absence of suspicious prostate nodule
Key exclusion criteria (3 listed)
- previous history of cancer
- BMI>30
- patients with previous diagnosis of PIN HG at prostate core biopsy or in active surveillance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Impedance-based analysis based on phase-sensitive sensors
Time frame: during rectal examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasms and PSA, run by University of Pisa at 1 site in Italy.
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 3 inclusion and 3 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 19 Feb 2018. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tommaso Di Vico, Resident (3393642655, urologiapisa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impedance-based analysis based on phase-sensitive sensors (time frame: during rectal examination). 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 19 Feb 2018.