A Study to Assess Mitomic Prostate Test for Prostate Cancer Screening

NCT05180305 | Unknown

• 1 other identifier: TSHMPT2001-P
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Mitomic Prostate Test (MPT)

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

  16 weeks

Secondary Outcomes (1)

• MPT compared to the current standard of care (SOC).

  16 weeks

Interventions

Mitomic Prostate Test DIAGNOSTIC_TEST

Mitomic Prostate Test

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TSH Biopharm Corporation Limited: lead

Study Sites (1)

Linkou Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The subject will be draw for 17 ml of blood in the screening phase.The blood sample will be sent to the central laboratory for analysis by Mitomic Mitomic Prostate Test Prostate TestProstate Test to detect the 3.4 kb mitochondrial DNA deletion.

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Jane Huang

CONTACT

0226558525; jane@tshbiopharm.com

Nick Li

CONTACT

0226558525; Nick_Li@tshbiopharm.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2021
• First Posted: January 6, 2022
• Study Start: April 27, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 6, 2022

Record last verified: 2022-01

Locations

TW (1)