Not Yet RecruitingNot Applicable

The Diagnostic Application of PSMAPET/MR in Patients Undergoing Secondary Prostate Puncture

China120 participantsStarted 2025-06-01

Plain-language summary

The present study is designed to explore the value of targeted puncture guided by PSMA PET/CT or mpMRI in the diagnosis of patients with low PSA and initial negative prostate biopsy

Who can participate

Age range

40 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age ≥40 years, male;
. Serum PSA level 4-20 ng/mL;
. Serum PSA level 4-20 ng/mL;
. No contraindications to PSMA-PET/CT or MRI;
. Signed informed consent.

Exclusion criteria

. Serum PSA \>20 ng/mL;
. History of prostate surgery/radiotherapy;
. Acute prostatitis;
. Coagulation disorders or active infection;
. Severe internal/external hemorrhoids, perianal, rectal, or gluteal lesions;
. Allergy to local anesthetics;
. Inability to tolerate the biopsy procedure.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Biospy outcome

Timeframe: 12 months

Trial details

NCT IDNCT06901492

SponsorNanjing First Hospital, Nanjing Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-01

Contact for this trial

Hongbin Sun Sun, MD, PHD

+86-02552271061 docshb@126.com

View on ClinicalTrials.gov More PSMA PET/CT trials