ClariCore™ Biopsy System in Patients Undergoing Radical Retropubic Prostatectomy
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ClinicalTrials.gov Identifier: NCT02773940 |
Recruitment Status :
Active, not recruiting
First Posted : May 16, 2016
Last Update Posted : February 15, 2019
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Condition or disease | Intervention/treatment | Phase |
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Prostate Cancer | Device: ClariCore System | Not Applicable |
The overall objective of this study is to acquire and analyze spectral data and correlative tissue biopsy cores using the ClariCore System for the purpose of algorithm development.
The system algorithm will be trained to identify real-time in vivo 'Normal' versus 'Suspicious' prostate tissue. The 'Normal' or 'Suspicious' assignment will be based on the optical signal principle component parameters of the measured signal when compared to a threshold to be derived from pathologically known values of suspicious (or possibly cancerous) and normal (or non-cancerous) measurements in prostate tissue.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Prospective, Multi-Center Study of the ClariCore™ Optical Biopsy System in Patients Undergoing Radical Retropubic Prostatectomy For Prostate Tissue Classification Algorithm Development |
Study Start Date : | May 2016 |
Estimated Primary Completion Date : | December 2019 |
Estimated Study Completion Date : | June 2020 |

Arm | Intervention/treatment |
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Experimental: ClariCore System
Biopsy tissue and correlative spectral data will be acquired using the ClariCore System during the patient's already scheduled radical retropubic prostatectomy (RRP) surgery.
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Device: ClariCore System
Biopsy tissue and correlative spectral data will be acquired using the ClariCore System during a patient's already scheduled radical retropubic prostatectomy (RRP) surgery. |
- Optical spectra measurements will be correlated with biopsy tissue core samples in patients with known prostate cancer undergoing radical retropubic prostatectomy surgery to develop a prostate tissue classification database [ Time Frame: Through study completion which ends at time of procedure completion ]
- All adverse events reported during the procedure that are related to the ClariCore System [ Time Frame: Through study completion which ends at time of procedure completion ]

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient scheduled for radical retropubic prostatectomy
- Prostate volume > 20cc and height at least 22mm (at the area(s) to be biopsied) as verified by ultrasound or MRI
- Patient, or authorized representative signs a written Informed Consent form to participate in the study, prior to any study mandated determinations or procedure
Exclusion Criteria:
- Patient opted for robotic (da Vinci robot) or laparoscopic surgery
- 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 has systemic infection or evidence of any surgical site infection (superficial or organ space), including active urinary tract infection
- Bladder cancer (current or prior)
- Actively taking blood thinning agents (with the exception of low dose aspirin {81 mg}, Plavix, Coumadin etc.) or severe medical comorbidity prohibiting halting of anticoagulation therapies or history of bleeding disorder (e.g. coagulopathy)
- Any malignancy other than non-melanoma cell skin cancer, unless no evidence of disease for a minimum of 5 years
- Hormone therapy for locally advanced disease (except patients on 5-alpha reductase inhibitors to reduce the size of the prostate)
- Neo-adjuvant hormonal therapy
- Salvage radical prostatectomy, i.e., patients having surgery due to failure of previous therapy (radiation, brachytherapy, cryotherapy, etc.)
- Patient has compromised immune system or autoimmune disease (WBC < 4000 or > 20,000)
- Patient is not likely to comply with the follow-up evaluation schedule
- Patient is participating in a clinical trial of another investigational drug or device
- Patient is mentally incompetent or a prisoner

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773940
United States, Maryland | |
Brady Urological Institute, Johns Hopkins Hospital | |
Baltimore, Maryland, United States, 21287 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Principal Investigator: | Alan W Partin, M.D., Ph.D. | Johns Hopkins University | |
Principal Investigator: | E. David Crawford, M.D. | University of Colorado, Denver |
Responsible Party: | Precision Biopsy, Inc. |
ClinicalTrials.gov Identifier: | NCT02773940 |
Other Study ID Numbers: |
STP-1002 |
First Posted: | May 16, 2016 Key Record Dates |
Last Update Posted: | February 15, 2019 |
Last Verified: | February 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |