A Study to Assess Mitomic Prostate Test for Prostate Cancer Screening

Prostate Cancer Clinical Trial

Official title:

A Study to Assess Mitomic Prostate Test for Prostate Cancer Screening

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05180305
• Other study ID #: TSHMPT2001-P
• Status: Recruiting
• Start date: April 27, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2022
• Source: TSH Biopharm Corporation Limited
• Contact: Jane Huang
• Phone: 0226558525
• Email: jane[@]tshbiopharm.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Gender: Male
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• Mitomic Prostate Test
Mitomic Prostate Test

Locations

Country	Name	City	State
Taiwan	Linkou Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
TSH Biopharm Corporation Limited

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mitomic Prostate Test (MPT)	To evaluate the diagnostic accuracy of the Mitomic Prostate Test (MPT) within the intended use population.	16 weeks
Secondary	MPT compared to the current standard of care (SOC).	To evaluate optimal disease screening strategies incorporating MPT compared to the current standard of care (SOC).	16 weeks