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New scan could spot prostate cancer earlier and more accurately

NCT ID NCT05422105

Diagnosis Sponsor: Primo Biotechnology Co., Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This trial evaluates a new imaging technique called 18F-PSMA-1007 PET/CT for detecting prostate cancer in men with elevated PSA levels (4-20 ng/mL) or abnormal rectal exams. The scan uses a radioactive tracer that targets a protein common on prostate cancer cells, aiming to improve accuracy over standard tests. About 230 men receiving their first prostate biopsy will be scanned to see how well this method identifies cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
18F-PSMA-1007
What this could lead to
If successful, this imaging method could become a more accurate, non-invasive way to detect early prostate cancer, reducing unnecessary biopsies.
What could go wrong
This is a diagnostic accuracy study, not a treatment trial. The scan may still miss some cancers or give false alarms, and results need confirmation in larger, diverse populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 230 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The patients with suspected prostate cancer had a serum PSA value between 4 and 20 ng/ml or a serum PSA value of \< 4ng/ml but noted abnormal lesions by digital rectal examination.

Ages

20 to 100 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria 1. The participants are male adults over 20 years old. 2. The participants are suspected prostate cancer patients by a serum PSA value of 4-20 ng/ml or a serum PSA value of \< 4ng/ml but noted abnormal lesion by DRE. 3. The participants agree to receive TRUS Bx or mpMRI fusion Bx examination. 4. The participants are the first time to receive a prostatic biopsy. Exclusion Criteria 1. The participants are diagnosed with prostate cancer before this study. 2. The participants have received any related treatment for prostate cancer. 3. The participants have chronic prostatitis. 4. The participants' serum hemoglobin lowers than 10 mg/dl within 1 month. 5. The participants' serum platelet lowers than 15 103/uL within 1 month. 6. The participants' serum prothrombin time (PT) is prolonged longer than 1.2-fold within 1 month. 7. The participants' serum active partial prothrombin time (aPPT) is prolonged longer than 45 seconds within 1 month. 8. The participants have hemorrhagic disease such as Hemophilia, Von Willebrand disease, thrombocytopenia, systemic Lupus Erythematosus, etc. within 6 months. 9. The participants have conditions of poor immunity status such as HIV infection, receiving treatment for other cancer, DM poor control, use of immunomodulator (ex. steroid, etc.) within 6 months. 10. The participants have hypertension poor control that is BP cannot be controlled lower than 140/90mmHg whether or not taking medication within 6 months. 11. The participants have suffered from CVA including infarctions and hemorrhages within 6 months. 12. The participants have suffered from angina including stable and unstable types within 6 months. 13. The participants have suffered from arrythmia poor control within 6 months. 14. The participants have suffered from liver dysfunction such as AST/ALT ratio \>2、total bilirubin \>1.5 mg/dL within 6 months. 15. The participants are allergic to any radiopharmaceutical or imaging agent. 16. The participants suffered stage IV chronic kidney disease (eGFR\<30 mL/min/1.73 m2) within 6 months 17. The participants suffered acute kidney injury within 6 months. 18. The participants are absolute and relative contraindications to MRI examination.

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Conditions

The condition(s) this trial relates to.

prostate cancer prostate neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer Prostate neoplasm

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Shin Kong Wu Ho-Su Memorial Hospital

    Taipei, 111, Taiwan

  • Tungs'Taichung Metro Harbor Hospital

    Taichung, 43503, Taiwan

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