A Study to Assess Mitomic Prostate Test for Prostate Cancer Screening

• Conditions: Prostate Cancer

• Registration Number: NCT05180305
• Lead Sponsor: TSH Biopharm Corporation Limited

Brief Summary

To evaluate the diagnostic accuracy of the Mitomic Prostate Test (MPT) comparing to prostate biopsy within the intended use population.

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 Timeline

• Study Start: 2021-04-27
• Study First Submitted: 2021-12-12
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-02
• Last Update Submitted: 2022-01-02
• Study First Posted: 2022-01-06
• Last Update Posted: 2022-01-06
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mitomic Prostate Test (MPT)	16 weeks	To evaluate the diagnostic accuracy of the Mitomic Prostate Test (MPT) within the intended use population.

Secondary Outcome Measures

Name	Time	Method
MPT compared to the current standard of care (SOC).	16 weeks	To evaluate optimal disease screening strategies incorporating MPT compared to the current standard of care (SOC).

Trial Locations

Locations (1)

Linkou Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan