PSMA PET/CTNCT06901492
The Diagnostic Application of PSMAPET/MR in Patients Undergoing Secondary Prostate Puncture
A study testing Prostate biopsy guided by PSMA PET/CT, Prostate biopsy guided by mpMRI/US and Systematic prostate biopsy in people with PSMA PET/CT and Prostate Cancer, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- PSMA PET/CT, Prostate Cancer, MpMRI
- What is being tested?
- Prostate biopsy guided by PSMA PET/CT, Prostate biopsy guided by mpMRI/US and Systematic prostate biopsy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 1 Jun 2028
- 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Hongbin Sun, MD, PHD, +86-02552271061, docshb@126.com
About this study
Official title: The Diagnostic Application of PSMA PET/MR in Patients with PSA <20 Ng/ml and Initial Negative Prostate Biopsy
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
- Conditions
- PSMA PET/CT, Prostate Cancer, MpMRI
- Being tested
- Prostate biopsy guided by PSMA PET/CT, Prostate biopsy guided by mpMRI/US, Systematic prostate biopsy
- Keywords
- Prostate cancer, PSMA PET/CT, mpMRI, Prostate biopsy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate biopsy guided by PSMA PET/CTDiagnostic test
The patient will undergo pelvic non-contrast CT imaging. After co-registration of the CT images with 68Ga-PSMA PET/CT data at corresponding anatomical levels, a percutaneous gluteal approach will be utilized for CT-guided prostate biopsy.
Prostate biopsy guided by mpMRI/USDiagnostic test
The patient will undergo transrectal ultrasound (TRUS) prostate scanning. After co-registration and precise image fusion of TRUS findings with multiparametric MRI (mpMRI) data, a transperineal percutaneous approach will be employed to perform TRUS-guided prostate biopsy.
Systematic prostate biopsyDiagnostic test
The patient will undergo systematic prostate biopsy under TRUS guidance.
| Study group | Role | What they receive |
|---|---|---|
| PET+/mpMRI+ group | Experimental | Patients in this group will undergo 68Ga-PSMA PET/mpMRI imaging, and the results show positive findings on both PSMA PET and mpMRI. These patients will undergo prostate biopsy guided by PSMA PET/CT. Receives: Diagnostic Test: Prostate biopsy guided by PSMA PET/CT |
| PET+/mpMRI- group | Experimental | Patients in this group will undergo 68Ga-PSMA PET/mpMRI imaging, and the results show positive findings on PSMA PET and negative on mpMRI. These patients will undergo prostate biopsy guided by PSMA PET/CT. Receives: Diagnostic Test: Prostate biopsy guided by PSMA PET/CT |
| PET-/mpMRI+ group | Active comparator | Patients in this group will undergo 68Ga-PSMA PET/mpMRI imaging, and the results show negative findings on PSMA PET and positive on mpMRI. These patients will undergo prostate biopsy guided by mpMRI and US. Receives: Diagnostic Test: Prostate biopsy guided by mpMRI/US |
| PET-/mpMRI- group | Placebo comparator | Patients in this group will undergo 68Ga-PSMA PET/mpMRI imaging, and the results show negative findings on both PSMA PET and mpMRI. These patients will undergo systematic prostate biopsy. Receives: Diagnostic Test: Systematic prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biospy outcome
Compare the diagnostic value (including sensitivity, specificity, NPV and PPV) between puncture methods and set up a diagnostic model.
Measured: 12 months
Secondary outcomes (4)
Duration of puncture operation
Record the time required for each patient's puncture procedure
Measured: 12 months
Patient's pain level
Based on VAS pain score
Measured: 12 months
Blood loss
Bleeding volume during and after operation
Measured: 12 months
Complication
Complications during and after the operation, including urethral injury, hematuria, and urinary tract infection, etc.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PSMA PET/CTStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06901492
- Sponsor's protocol ID
- KY20250225-08
- Status last verified
- Mar 2025
- First submitted
- 23 Mar 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Application of PSMA PET/MR in Patients with PSA <20 Ng/ml and Initial Negative Prostate Biopsy
- ClinicalTrials.gov ID
- NCT06901492
- Acronym / sponsor ID
- KY20250225-08
- Conditions
- PSMA PET/CT, Prostate Cancer, MpMRI
- Keywords
- Prostate cancer, PSMA PET/CT, mpMRI, Prostate biopsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 30 Mar 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 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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PET+/mpMRI+ group | Experimental | Diagnostic Test: Prostate biopsy guided by PSMA PET/CTPatients in this group will undergo 68Ga-PSMA PET/mpMRI imaging, and the results show positive findings on both PSMA PET and mpMRI. These patients will undergo prostate biopsy guided by PSMA PET/CT. |
| PET+/mpMRI- group | Experimental | Diagnostic Test: Prostate biopsy guided by PSMA PET/CTPatients in this group will undergo 68Ga-PSMA PET/mpMRI imaging, and the results show positive findings on PSMA PET and negative on mpMRI. These patients will undergo prostate biopsy guided by PSMA PET/CT. |
| PET-/mpMRI+ group | Active comparator | Diagnostic Test: Prostate biopsy guided by mpMRI/USPatients in this group will undergo 68Ga-PSMA PET/mpMRI imaging, and the results show negative findings on PSMA PET and positive on mpMRI. These patients will undergo prostate biopsy guided by mpMRI and US. |
| PET-/mpMRI- group | Placebo comparator | Diagnostic Test: Systematic prostate biopsyPatients in this group will undergo 68Ga-PSMA PET/mpMRI imaging, and the results show negative findings on both PSMA PET and mpMRI. These patients will undergo systematic prostate biopsy. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
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 |
|---|---|---|
| Prostate biopsy guided by PSMA PET/CTThe patient will undergo pelvic non-contrast CT imaging. After co-registration of the CT images with 68Ga-PSMA PET/CT data at corresponding anatomical levels, a percutaneous gluteal approach will be utilized for CT-guided prostate biopsy. | Diagnostic test | PET+/mpMRI+ group, PET+/mpMRI- group |
| Prostate biopsy guided by mpMRI/USThe patient will undergo transrectal ultrasound (TRUS) prostate scanning. After co-registration and precise image fusion of TRUS findings with multiparametric MRI (mpMRI) data, a transperineal percutaneous approach will be employed to perform TRUS-guided prostate biopsy. | Diagnostic test | PET-/mpMRI+ group |
| Systematic prostate biopsyThe patient will undergo systematic prostate biopsy under TRUS guidance. | Diagnostic test | PET-/mpMRI- group |
Primary outcome
Biospy outcome
Time frame: 12 months
Compare the diagnostic value (including sensitivity, specificity, NPV and PPV) between puncture methods and set up a diagnostic model.
4 secondary outcomes
Duration of puncture operation
Time frame: 12 months
Patient's pain level
Time frame: 12 months
Blood loss
Time frame: 12 months
Complication
Time frame: 12 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 30 Mar 2025.
- 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 Prostate biopsy guided by PSMA PET/CT, Prostate biopsy guided by mpMRI/US and Systematic prostate biopsy in people with PSMA PET/CT and Prostate Cancer, run by Nanjing First Hospital, Nanjing 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: opening soon, as of the sponsor's last update on 30 Mar 2025. 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. Some participants in this study may receive a placebo. 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 Hongbin Sun Sun, MD, PHD (+86-02552271061, docshb@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biospy outcome (time frame: 12 months). 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 30 Mar 2025.