Prostate CancerNCT05180305
A Study to Assess Mitomic Prostate Test for Prostate Cancer Screening
An observational study of Prostate Cancer, run by TSH Biopharm Corporation Limited at 1 site in Taiwan.
Trial summary
To evaluate the diagnostic accuracy of the Mitomic Prostate Test (MPT) comparing to prostate biopsy within the intended use population. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Mitomic Prostate Test
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Apr 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Linkou Chang Gung Memorial Hospital
Taoyuan, 333
About this study
To evaluate the diagnostic accuracy of the Mitomic Prostate Test (MPT) comparing to prostate biopsy within the intended use population.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Mitomic Prostate Test
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitomic Prostate TestDiagnostic test
Mitomic Prostate Test
What is being measured
The primary outcome is the main question the study is designed to answer.
Mitomic Prostate Test (MPT)
To evaluate the diagnostic accuracy of the Mitomic Prostate Test (MPT) within the intended use population.
Measured: 16 weeks
Secondary outcomes (1)
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).
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start27 Apr 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TSH Biopharm Corporation Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180305
- Sponsor's protocol ID
- TSHMPT2001-P
- Status last verified
- Jan 2022
- First submitted
- 12 Dec 2021
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess Mitomic Prostate Test for Prostate Cancer Screening
- ClinicalTrials.gov ID
- NCT05180305
- Acronym / sponsor ID
- TSHMPT2001-P
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- TSH Biopharm Corporation LimitedIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 6 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitomic Prostate TestMitomic Prostate Test | Diagnostic test | – |
Primary outcome
Mitomic Prostate Test (MPT)
Time frame: 16 weeks
To evaluate the diagnostic accuracy of the Mitomic Prostate Test (MPT) within the intended use population.
1 secondary outcome
MPT compared to the current standard of care (SOC).
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by TSH Biopharm Corporation Limited at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jane Huang (0226558525, jane@tshbiopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mitomic Prostate Test (MPT) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2022.