Prostate Cancer ScreeningNCT06923657
PSMA PET/MRI-Guided Prostate Biopsy for PI-RADS ≤3 and Prior Negative Biopsy
A study testing PSMA PET/MRI-TRUS guided prostate targeted combined saturation biopsy and TRUS guided transperineal saturation biopsy in people with Prostate Cancer Screening and PSMA-PET, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 85 years, men only
- Conditions the study is for
- Prostate Cancer Screening, PSMA-PET
- What is being tested?
- PSMA PET/MRI-TRUS guided prostate targeted combined saturation biopsy and TRUS guided transperineal saturation biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteChina
- Study dates
- 7 May 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
Ning Xu, 059187981687, drxun@fjmu.edu.cn
About this study
Official title: Application of PSMA PET/MRI-guided Prostate Targeted Biopsy in Patients With PI-RADS ≤ 3 and Negative Previous Biopsy: A Single-center, Prospective, Open-label, Randomized Controlled Trial
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.
Read the detailed description
This research intends to prospectively enroll patients with prior negative biopsies, a PI-RADS score ≤ 3, and persistent PSA or PHI elevation, randomly assigning them to the PSMA PET/MRI group (experimental group) and the TRUS-guided transperineal saturation biopsy group (control group). The research aims to evaluate the application of PSMA PET/MRI in clinically suspected prostate cancer patients with prior negative biopsies, comparing the differences in csPCa detection rates between PSMA PET/MRI-TRUS guided prostate targeted biopsy and TRUS-guided saturation biopsy.
- Conditions
- Prostate Cancer Screening, PSMA-PET
- Being tested
- PSMA PET/MRI-TRUS guided prostate targeted combined saturation biopsy, TRUS guided transperineal saturation biopsy
- Keywords
- imaging examinations, PSMA PET/MRI, Prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSMA PET/MRI-TRUS guided prostate targeted combined saturation biopsyDiagnostic test
The experimental group will undergo PSMA PET/MRI examination. For those with positive PSMA PET/MRI results, a PSMA PET/MRI-TRUS guided prostate targeted biopsy will be performed based on transrectal ultrasound (TRUS) guided transperineal saturation biopsy, targeting the positive lesions. For those with negative PSMA PET/MRI results, only TRUS guided transperineal saturation biopsy will be performed. Clinical and pathological data of the patients will be collected for statistical analysis.
TRUS guided transperineal saturation biopsyDiagnostic test
The control group will receive TRUS guided transperineal saturation biopsy. Clinical and pathological data of the patients will be collected for statistical analysis.
| Study group | Role | What they receive |
|---|---|---|
| The control group | Active comparator | The control group will receive TRUS guided transperineal saturation biopsy. Receives: Diagnostic Test: TRUS guided transperineal saturation biopsy |
| The experimental group | Experimental | The experimental group will undergo PSMA PET/MRI examination. For those with positive PSMA PET/MRI results, a PSMA PET/MRI-TRUS guided prostate targeted biopsy will be performed based on transrectal ultrasound (TRUS) guided transperineal saturation biopsy, targeting the positive lesions. For those with negative PSMA PET/MRI results, only TRUS guided transperineal saturation biopsy will be performed. Receives: Diagnostic Test: PSMA PET/MRI-TRUS guided prostate targeted combined saturation biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Sensitivity
It refers to the percentage of patients who actually have prostate cancer correctly identified as positive (true positive). The calculation formula is: TP/(TP+FN)×100%. TP is true positive, and FN is false negative.
Measured: Perioperative
Diagnostic Specificity
It refers to the percentage of patients who do not actually have prostate cancer correctly identified as negative (true negative). The calculation formula is: TN/(TN+FP)×100%. TN is true negative, and FP is false positive.
Measured: Perioperative
Positive Predictive Value(PPV)
It refers to the proportion of true positives among the positive results obtained by a specific testing method. The calculation formula is: PPV = TP/(TP+FP)×100%.
Measured: Perioperative
Negative Predictive Value(NPV)
It refers to the proportion of true negatives among the negative results obtained by a specific testing method. The calculation formula is: NPV = TN/(TN+FN)×100%.
Measured: Perioperative
Positive Likelihood Ratio(PLR)
It refers to the ratio of the probability of correctly identifying a patient with prostate cancer as positive to the probability of incorrectly identifying a patient without prostate cancer as positive. The calculation formula is: +LR = Sensitivity / (1- Specificity)×100%.
Measured: Perioperative
Negative Likelihood Ratio(NLR)
It refers to the ratio of the probability of incorrectly identifying a patient with prostate cancer as negative to the probability of correctly identifying a patient without prostate cancer as negative. The calculation formula is:-LR = (1- Sensitivity) / Specificity×100%.
Measured: Perioperative
Correct Diagnostic Index
It refers to the sum of sensitivity and specificity minus 1. The correct diagnostic index can be used for comparing two diagnostic methods, with an ideal correct diagnostic index of 100%.r = (Specificity+Sensitivity) -1 = 1- (False Positive Rate + False Negative Rate).
Measured: Perioperative
Secondary outcomes (4)
PRECISION Questionnaire
The incidence of complications for the two biopsy methods.
Measured: 1 week before biopsy, 1 week after biopsy, 1 month, 3 months, 6 months, 12 months.
EORTC QLQ-C30 Questionnaire
The change in quality of life compared to baseline values in the experimental group and control group.
Measured: Before diagnosis, 1 month, 3 months, 6 months, 12 months
Generalized Anxiety Disorder GAD-7 Scale
The difference in anxiety levels at each time point between the experimental group and the control group.
Measured: Before diagnosis, 1 week after diagnosis, 1 month, 3 months, 6 months, 12 months
Decision Conflict Scale, Decision Regret Scale
The decision-making differences at each time point between the experimental group and the control group.
Measured: Before diagnosis, 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start7 May 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Fujian Medical UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ning Xu, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923657
- Sponsor's protocol ID
- MRCTA,ECFAH OfFMU[2024]837
- Status last verified
- May 2026
- First submitted
- 26 Mar 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of PSMA PET/MRI-guided Prostate Targeted Biopsy in Patients With PI-RADS ≤ 3 and Negative Previous Biopsy: A Single-center, Prospective, Open-label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06923657
- Acronym / sponsor ID
- MRCTA,ECFAH OfFMU[2024]837
- Conditions
- Prostate Cancer Screening, PSMA-PET
- Keywords
- imaging examinations, PSMA PET/MRI, Prostate cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 7 May 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 11 Apr 2025 (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.
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.
Detailed description
This research intends to prospectively enroll patients with prior negative biopsies, a PI-RADS score ≤ 3, and persistent PSA or PHI elevation, randomly assigning them to the PSMA PET/MRI group (experimental group) and the TRUS-guided transperineal saturation biopsy group (control group). The research aims to evaluate the application of PSMA PET/MRI in clinically suspected prostate cancer patients with prior negative biopsies, comparing the differences in csPCa detection rates between PSMA PET/MRI-TRUS guided prostate targeted biopsy and TRUS-guided saturation biopsy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The control group | Active comparator | Diagnostic Test: TRUS guided transperineal saturation biopsyThe control group will receive TRUS guided transperineal saturation biopsy. |
| The experimental group | Experimental | Diagnostic Test: PSMA PET/MRI-TRUS guided prostate targeted combined saturation biopsyThe experimental group will undergo PSMA PET/MRI examination. For those with positive PSMA PET/MRI results, a PSMA PET/MRI-TRUS guided prostate targeted biopsy will be performed based on transrectal ultrasound (TRUS) guided transperineal saturation biopsy, targeting the positive lesions. For those with negative PSMA PET/MRI results, only TRUS guided transperineal saturation biopsy will be performed. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.)
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 |
|---|---|---|
| PSMA PET/MRI-TRUS guided prostate targeted combined saturation biopsyThe experimental group will undergo PSMA PET/MRI examination. For those with positive PSMA PET/MRI results, a PSMA PET/MRI-TRUS guided prostate targeted biopsy will be performed based on transrectal ultrasound (TRUS) guided transperineal saturation biopsy, targeting the positive lesions. For those with negative PSMA PET/MRI results, only TRUS guided transperineal saturation biopsy will be performed. Clinical and pathological data of the patients will be collected for statistical analysis. | Diagnostic test | The experimental group |
| TRUS guided transperineal saturation biopsyThe control group will receive TRUS guided transperineal saturation biopsy. Clinical and pathological data of the patients will be collected for statistical analysis. | Diagnostic test | The control group |
Primary outcome
Diagnostic Sensitivity
Time frame: Perioperative
It refers to the percentage of patients who actually have prostate cancer correctly identified as positive (true positive). The calculation formula is: TP/(TP+FN)×100%. TP is true positive, and FN is false negative.
Diagnostic Specificity
Time frame: Perioperative
It refers to the percentage of patients who do not actually have prostate cancer correctly identified as negative (true negative). The calculation formula is: TN/(TN+FP)×100%. TN is true negative, and FP is false positive.
Positive Predictive Value(PPV)
Time frame: Perioperative
It refers to the proportion of true positives among the positive results obtained by a specific testing method. The calculation formula is: PPV = TP/(TP+FP)×100%.
Negative Predictive Value(NPV)
Time frame: Perioperative
It refers to the proportion of true negatives among the negative results obtained by a specific testing method. The calculation formula is: NPV = TN/(TN+FN)×100%.
Positive Likelihood Ratio(PLR)
Time frame: Perioperative
It refers to the ratio of the probability of correctly identifying a patient with prostate cancer as positive to the probability of incorrectly identifying a patient without prostate cancer as positive. The calculation formula is: +LR = Sensitivity / (1- Specificity)×100%.
Negative Likelihood Ratio(NLR)
Time frame: Perioperative
It refers to the ratio of the probability of incorrectly identifying a patient with prostate cancer as negative to the probability of correctly identifying a patient without prostate cancer as negative. The calculation formula is:-LR = (1- Sensitivity) / Specificity×100%.
Correct Diagnostic Index
Time frame: Perioperative
It refers to the sum of sensitivity and specificity minus 1. The correct diagnostic index can be used for comparing two diagnostic methods, with an ideal correct diagnostic index of 100%.r = (Specificity+Sensitivity) -1 = 1- (False Positive Rate + False Negative Rate).
4 secondary outcomes
PRECISION Questionnaire
Time frame: 1 week before biopsy, 1 week after biopsy, 1 month, 3 months, 6 months, 12 months.
EORTC QLQ-C30 Questionnaire
Time frame: Before diagnosis, 1 month, 3 months, 6 months, 12 months
Generalized Anxiety Disorder GAD-7 Scale
Time frame: Before diagnosis, 1 week after diagnosis, 1 month, 3 months, 6 months, 12 months
Decision Conflict Scale, Decision Regret Scale
Time frame: Before diagnosis, 1 month, 3 months, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSMA PET/MRI-TRUS guided prostate targeted combined saturation biopsy and TRUS guided transperineal saturation biopsy in people with Prostate Cancer Screening and PSMA-PET, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 28 May 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ning Xu (13235907575 ext. 0086, drxun@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Sensitivity (time frame: Perioperative). The study lists 7 primary outcomes in all. 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 28 May 2026.