RecruitingNot Applicable

PSMA PET/MRI-Guided Prostate Biopsy for PI-RADS ≤3 and Prior Negative Biopsy

China230 participantsStarted 2025-05-07

Plain-language summary

The goal is to provide more accurate diagnostic tools and optimized diagnostic workflows for clinically suspected prostate cancer patients with prior negative biopsies, improving early detection rates for csPCa and reducing missed diagnoses.

Who can participate

Age range

30 Years – 85 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: * Serum PSA \> 4 ng/mL * At least one prior negative prostate biopsy * At least two consecutive increases in PSA and/or PHI * Negative digital rectal examination * Multiparametric MRI (mpMRI) indicating a PI-RADS score ≤ 3 Exclusion Criteria * Age ≤ 30 years or \> 85 years * Concurrent presence of other malignant tumors * Previous treatment with any form of anti-tumor therapy or prostate surgery (excluding prostate biopsy) * Inability to comply with PSMA PET/MRI examination (e.g., contrast allergy, claustrophobia, etc.) * Contraindications for prostate biopsy (e.g., coagulation disorders, acute prostatitis, acute urinary tract infection, etc.) * Severe organ dysfunction (e.g., significant cardiac, pulmonary, hepatic, or renal impairment) * Incomplete clinical or pathological data

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

Diagnostic Sensitivity

Timeframe: Perioperative

Diagnostic Specificity

Timeframe: Perioperative

Positive Predictive Value(PPV)

Timeframe: Perioperative

Negative Predictive Value(NPV)

Timeframe: Perioperative

Positive Likelihood Ratio(PLR)

Timeframe: Perioperative

Negative Likelihood Ratio(NLR)

Timeframe: Perioperative

Correct Diagnostic Index

Timeframe: Perioperative

Trial details

NCT IDNCT06923657

SponsorFirst Affiliated Hospital of Fujian Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-01

Contact for this trial

Ning Xu

13235907575 drxun@fjmu.edu.cn

View on ClinicalTrials.gov More Prostate Cancer Screening trials

Who can participate

Age range

30 Years – 85 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.

What they're measuring

Diagnostic Sensitivity

Timeframe: Perioperative

Diagnostic Specificity

Timeframe: Perioperative

Positive Predictive Value(PPV)

Timeframe: Perioperative

Negative Predictive Value(NPV)

Timeframe: Perioperative

Positive Likelihood Ratio(PLR)

Timeframe: Perioperative

Negative Likelihood Ratio(NLR)

Timeframe: Perioperative

Correct Diagnostic Index

Timeframe: Perioperative