Mitomic Prostate Test in Prostate Cancer - Clinical Trials Registry

Study Overview

Status

Recruiting

Conditions

Prostate Cancer

Intervention / Treatment

Diagnostic test: Mitomic Prostate Test

Detailed Description

To determine the clinical performance of a blood-based test for clinically significant (CS) prostate cancer (PCa) (grade group ≥ 2) intended for use in men with prostate serum antigen levels in the 'grey zone' (PSA < 10 ng/ml). The test quantifies a previously described 3.4 kb mitochondrial DNA (mtDNA) deletion.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Jane Huang
Phone Number: 0226558525
Email: jane@tshbiopharm.com

Study Contact Backup

Name: Nick Li
Phone Number: 0226558525
Email: Nick_Li@tshbiopharm.com

Study Locations

Taiwan
- - Taoyuan, Taiwan, 333
    - Recruiting
    - Linkou Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

To investigate the mitochondrial DNA biomarker in a large group of patients suspicious for prostate cancer to evaluate the Mitomic Prostate Test (MPT)'s accuracy in target population.

Description

Inclusion Criteria:

Men of screening age (≧45) who are scheduled for prostate needle biopsy due to suspicion of prostate cancer and have a total PSA < 10ng/ml within the previous 3 months.
Extended Sextant biopsy pattern that must include a minimum of 12 cores. MRI targeted biopsy preferred where available.
Age, total PSA, biopsy pathology, prostate medication history, and ethnicity data must be available;
The index biopsy must occur following and within 16 weeks of blood draw.

Exclusion Criteria:

Subject does not undergo their prostate biopsy within 16 weeks of collection of pre-biopsy blood sample;
Previous diagnosis of prostate cancer;
Prostate biopsy within the previous 3 months;
Men with a total PSA>10ng/ml within the previous 3 months;
Provides less than the required amount of blood;
Considered incompetent to provide informed consent;
Does not understand and read language of informed consent;
Age, total PSA, biopsy pathology information, medication history or ethnicity data unavailable;
Males who are not of screening age (<45);
Subjects whose classification as cancer positive or negative is undetermined following biopsy due to suspicious results such as Atypical Suspicious Acinar Proliferation (ASAP);
Blood collected after index biopsy.
Subject is taking antibiotics at the time of blood collection or has taken antibiotics within the 2 weeks prior to blood collection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Case-Only
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mitomic Prostate Test (MPT) Time Frame: 16 weeks	To evaluate the diagnostic accuracy of the Mitomic Prostate Test (MPT) within the intended use population.	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MPT compared to the current standard of care (SOC). Time Frame: 16 weeks	To evaluate optimal disease screening strategies incorporating MPT compared to the current standard of care (SOC).	16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TSH Biopharm Corporation Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)