NCT06901492

Brief 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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
26mo left

Started Jun 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Jun 2025Jun 2028

First Submitted

Initial submission to the registry

March 23, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 30, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

2 years

First QC Date

March 23, 2025

Last Update Submit

March 23, 2025

Conditions

PSMA PET/CTProstate CancerMpMRI

Keywords

Prostate cancerPSMA PET/CTmpMRIProstate biopsy

Outcome Measures

Primary Outcomes (1)

  • Biospy outcome

    Compare the diagnostic value (including sensitivity, specificity, NPV and PPV) between puncture methods and set up a diagnostic model.

    12 months

Secondary Outcomes (4)

  • Duration of puncture operation

    12 months

  • Patient's pain level

    12 months

  • Blood loss

    12 months

  • Complication

    12 months

Study Arms (4)

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.

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.

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.

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.

Diagnostic Test: Systematic prostate biopsy

Interventions

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.

PET+/mpMRI+ groupPET+/mpMRI- group
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.

PET-/mpMRI+ group
Systematic prostate biopsyDIAGNOSTIC_TEST

The patient will undergo systematic prostate biopsy under TRUS guidance.

PET-/mpMRI- group

Eligibility Criteria

Age40 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Central Study Contacts

Hongbin Sun Sun, MD, PHD

CONTACT

+86-02552271061docshb@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2025

First Posted

March 30, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

March 30, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)