Cellular Diagnosis, Prostate CancerSCORENCT03504761
ClariCore System Used in Transrectal Ultrasound Guided Prostate Biopsy for Real-Time Tissue Evaluation
A study testing ClariCore Optical Biopsy System in people with Cellular Diagnosis, Prostate Cancer, run by Precision Biopsy, Inc. at 6 sites in United States.
Trial summary
The purpose of this study is to demonstrate the effectiveness and safety of the ClariCore System in obtaining prostate biopsies with device feedback that provides real-time tissue classification. Read more about this study
- Who is it for?
- Ages 22 years and older, men only
- Conditions the study is for
- Cellular Diagnosis, Prostate Cancer
- What is being tested?
- ClariCore Optical Biopsy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 6 sitesUnited States
- Study dates
- 25 Apr 2018to Dec 2020
- 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 22 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males > 22 years old
- Patient scheduled for TRUS-guided prostate biopsy based on standard of care urologic requirements to assess for tissue malignancy (abnormal Digital Rectum Examination, Prostate Specific Antigen kinetics, age, ethnicity, family history, etc.)
- Enrolling physician must have expectation that prostate dimensions will meet minimum prostate volume and height requirements that will be evaluated at start of biopsy procedure (i.e., Prostate volume > 20cc and height at least 22mm)
- Patient signs an Institutional Review Board approved, Informed Consent form to participate in the study prior to any study mandated determinations or procedure
Who cannot join
- Any anatomical or co-morbidity contraindications to TRUS prostate biopsy
- Acute painful perianal disorder (i.e. rectal abscess)
- Symptomatic, acute prostatitis
- Surgical absence of a rectum or the presence of a rectal fistula
- Patient has systemic infection or evidence of any surgical site infection (superficial or organ space), including active urinary tract infection
- Previous prostate intervention [Transurethral Prostatectomy (TURP) (bipolar, monopolar, laser)], Transurethral Microwave Thermotherapy (TUMT), High-Intensity Focused Ultrasound (HIFU), Cryo, Rezum, Urolift], not including previous prostate biopsy
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- Current use of blood thinning agents for medical comorbidity which prohibits the cessation of use as typically required per standard of care (SOC) or history of a bleeding disorder (e.g. coagulopathy)
- Prior pelvic irradiation
- Actively receiving therapy for the treatment of cancer (except for patients on 5-alpha reductase inhibitors, or non-melanoma skin cancers that are managed nonsystemically)
- Actively receiving intravesical therapy or within 6 months of treatment for bladder cancer
- Patient has compromised immune system
- Active inflammatory bowel disease within the last 6 months
- Any condition, or history of illness or surgery that, in the opinion of the Investigator, might confound the results of the study or pose additional risks to the patient (e.g. significant cardiovascular conditions or allergies)
- Patient is not likely to comply with the protocol or follow up evaluation
- Patient is participating in a clinical trial of another investigational drug or device that may impact participation in this clinical study
- Patient is unable to provide legal Informed Consent
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites, 6 recruiting
- Not yet recruiting
Brady Urological Institute, Johns Hopkins Hospital
Baltimore, Maryland, 21287
Robin Gurganus, RN, CCRC, 410-614-6926, rgurganus@jhmi.edu
Leslie Mangold, MS, 410-955-2139, lmangold@jhmi.edu
- Recruiting
The Urology Center of Colorado
Denver, Colorado, 80211
Robin Dorsey, 303-762-7155
Larry Karsh, MD
- Recruiting
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Jennifer Baiden, 843-449-1010 ext. 237, jbaiden@atlanticurologyclinics.com
Neal Shore, MD
- Recruiting
NYU Langone Urology Associates
New York, New York, 10016
Elton Llukani, Elton.Llukani@nyumc.org
James Wysock, MD, James.Wysock@nyumc.org
- Not yet recruiting
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Melissa Salerno, BS, salernom@mskcc.org
Tanya Milan, MPH, 646-227-2231, milanrot@mskcc.org
- Not yet recruiting
Urology of San Antonio
San Antonio, Texas, 78229
Manuel R Hernandez, 210-617-4116, manuel.hernandez@urologysa.com
Daniel Saltzstein, MD
About this study
Official title: Prospective, Multi-Center Study of the ClariCore Optical Biopsy System in Patients Undergoing Transrectal Ultrasound (TRUS)-Guided Prostate Biopsy for Real-Time Tissue Evaluation
The purpose of this study is to demonstrate the effectiveness and safety of the ClariCore System in obtaining prostate biopsies with device feedback that provides real-time tissue classification.
Read the detailed description
The purpose of this study is to collect information on prostate biopsies using the ClariCore System. The ClariCore System is designed to improve how the biopsies are being collected from the prostate by using light sensors (fiber optics) that can see changes in the prostate tissue. Researchers will study the information collected from the light sensors to study a method that has been developed to tell the difference between normal and suspicious (possibly cancerous) prostate tissue during the biopsy. This information will be given to the doctor in real-time. From this study, researchers hope to learn if this method can tell the difference between normal and suspicious prostate tissue, and if this can improve the evaluation of prostate tissue (biopsies).
- Conditions
- Cellular Diagnosis, Prostate Cancer
- Being tested
- ClariCore Optical Biopsy System
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClariCore Optical Biopsy SystemDevice
Also called ClariCore System
Demonstrate the efficacy and safety of the ClariCore System in obtaining prostate biopsies utilizing real-time tissue classification.
| Study group | Role | What they receive |
|---|---|---|
| ClariCore System | Experimental | ClariCore System study designed to obtain prostate biopsies utilizing real-time tissue classification with the ClariCore Optical Biopsy System. Receives: Device: ClariCore Optical Biopsy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the tissue classification algorithm
Correlate histopathology of tissue biopsy core samples with the tissue classification algorithm results obtained at the time of the procedure to validate the tissue classification algorithm.
Measured: At time of procedure
Secondary outcomes (2)
Sensitivity and Specificity
The sensitivity and specificity of the ClariCore System will be calculated and reported.
Measured: At time of procedure
Cancer Detection Rate
The cancer detection per core rate in the Targeted Cores that have been classified as suspicious will be determined and reported.
Measured: At time of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start25 Apr 2018
- Primary completionJan 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cellular Diagnosis, 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 325 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Precision Biopsy, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neal Shore, M.D., Principal investigator, Carolina Urologic Research Center/Atlantic Urology Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504761
- Sponsor's protocol ID
- CIP-1010-B
- Acronym
- SCORE
- Status last verified
- Feb 2019
- First submitted
- 6 Apr 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-Center Study of the ClariCore Optical Biopsy System in Patients Undergoing Transrectal Ultrasound (TRUS)-Guided Prostate Biopsy for Real-Time Tissue Evaluation
- ClinicalTrials.gov ID
- NCT03504761
- Acronym / sponsor ID
- SCORE / CIP-1010-B
- Conditions
- Cellular Diagnosis, Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 325 participants (estimated)
- Lead sponsor
- Precision Biopsy, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 20 Apr 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.
The purpose of this study is to demonstrate the effectiveness and safety of the ClariCore System in obtaining prostate biopsies with device feedback that provides real-time tissue classification.
Detailed description
The purpose of this study is to collect information on prostate biopsies using the ClariCore System. The ClariCore System is designed to improve how the biopsies are being collected from the prostate by using light sensors (fiber optics) that can see changes in the prostate tissue. Researchers will study the information collected from the light sensors to study a method that has been developed to tell the difference between normal and suspicious (possibly cancerous) prostate tissue during the biopsy. This information will be given to the doctor in real-time. From this study, researchers hope to learn if this method can tell the difference between normal and suspicious prostate tissue, and if this can improve the evaluation of prostate tissue (biopsies).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ClariCore System | Experimental | Device: ClariCore Optical Biopsy SystemClariCore System study designed to obtain prostate biopsies utilizing real-time tissue classification with the ClariCore Optical Biopsy System. |
Who may qualify
- Ages
- 22 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males > 22 years old
- Patient scheduled for TRUS-guided prostate biopsy based on standard of care urologic requirements to assess for tissue malignancy (abnormal Digital Rectum Examination, Prostate Specific Antigen kinetics, age, ethnicity, family history, etc.)
- Enrolling physician must have expectation that prostate dimensions will meet minimum prostate volume and height requirements that will be evaluated at start of biopsy procedure (i.e., Prostate volume > 20cc and height at least 22mm)
- Patient signs an Institutional Review Board approved, Informed Consent form to participate in the study prior to any study mandated determinations or procedure
Key exclusion criteria (16 listed)
- Any anatomical or co-morbidity contraindications to TRUS prostate biopsy
- Acute painful perianal disorder (i.e. rectal abscess)
- Symptomatic, acute prostatitis
- Surgical absence of a rectum or the presence of a rectal fistula
- Patient has systemic infection or evidence of any surgical site infection (superficial or organ space), including active urinary tract infection
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 |
|---|---|---|
| ClariCore Optical Biopsy SystemAlso: ClariCore SystemDemonstrate the efficacy and safety of the ClariCore System in obtaining prostate biopsies utilizing real-time tissue classification. | Device | ClariCore System |
Primary outcome
Validation of the tissue classification algorithm
Time frame: At time of procedure
Correlate histopathology of tissue biopsy core samples with the tissue classification algorithm results obtained at the time of the procedure to validate the tissue classification algorithm.
2 secondary outcomes
Sensitivity and Specificity
Time frame: At time of procedure
Cancer Detection Rate
Time frame: At time of procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Neal Shore, M.D. principal investigator
Carolina Urologic Research Center/Atlantic Urology Clinics
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ClariCore Optical Biopsy System in people with Cellular Diagnosis, Prostate Cancer, run by Precision Biopsy, Inc. at 6 sites 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 4 inclusion and 16 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 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
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 Amanda K Jonas, B.S. (510-676-0904, amanda.jonas@precisionbiopsy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of the tissue classification algorithm (time frame: At time of procedure). 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 15 Feb 2019.