A Study to Assess Mitomic Prostate Test for Prostate Cancer Screening

Sponsor
TSH Biopharm Corporation Limited (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05180305
Collaborator
(none)
200
1
20.1
9.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
A Study to Assess Mitomic Prostate Test for Prostate Cancer Screening
Actual Study Start Date :
Apr 27, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years and Older
Sexes Eligible for Study:
Male
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Linkou Chang Gung Memorial Hospital Taoyuan Taiwan 333

Sponsors and Collaborators

  • TSH Biopharm Corporation Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
TSH Biopharm Corporation Limited
ClinicalTrials.gov Identifier:
NCT05180305
Other Study ID Numbers:
  • TSHMPT2001-P
First Posted:
Jan 6, 2022
Last Update Posted:
Jan 6, 2022
Last Verified:
Jan 1, 2022
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 6, 2022