The Application Value of Prostate Specific Membrane Antigen PET/CT in Biopsy Free of PSA Grey Area Prostate Cancer

NCT05958004 | Completed

• 1 other identifier: XJTU1AF2023LSK-367
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to establish an evaluation system for accurate identification of prostate cancer and clinical significant prostate cancer in patients in the PSA gray zone. The main questions it aims to answer are: proportion of men who could have avoided biopsy with positive PSMA-PET and no clinically significant cancer detected on biopsy. Participants will: 1. undergo PSMA PET/CT and multiparametric MRI; and 2. undergo prostate biopsy Researchers will compare the diagnostic performance of PSMA PET/CT and multiparametric MRI for prostate cancer and clinical significant prostate cancer to see if there are differences.

Conditions

Prostatic Neoplasms

Keywords

PET/CT; PSMA; PSA grey area

Outcome Measures

Primary Outcomes (2)

• detection rate of prostate cancer

  detection rate of prostate cancer

  about 1 year

• detection rate of clinical significant prostate cancer

  detection rate of clinical significant prostate cancer

  about 1 year

Secondary Outcomes (2)

• gleason score group prediction

  about 1 year

• expression level of survival-related genes

  about 1 year

Study Arms (2)

Non-Prostate Cancer

Participants who are suspected of prostate cancer due to elevated PSA but have not received any treatment and eventually confirmed non-prostate cancer after biopsies

Prostate Cancer

Participants who are suspected of prostate cancer due to elevated PSA but have not received any treatment and eventually confirmed prostate cancer after biopsies

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

-Patients with elevated PSA levels in the First Affiliated Hospital of Xi'an Jiaotong University be included in this study with signed informed consent.

You may qualify if:

• PSA (4-10 ng/mL)
• MRI and PSMA PET/CT were not contraindicated
• Did not receive prostate-related treatment
• There are no contraindications to biopsy

You may not qualify if:

• Coexisting with other malignancies

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Related Publications (1)

• Luo L, Wang R, Bai L, Shang J, Wang X, Chang R, Dong W, Li Y, Li Y, Liang H, Xie H, Duan X. The accuracy of fluorine 18-labelled prostate-specific membrane antigen PET/CT and MRI for diagnosis of prostate cancer in PSA grey zone. Br J Cancer. 2025 Feb;132(3):253-258. doi: 10.1038/s41416-024-02934-x. Epub 2024 Dec 19.

  PMID: 39702584 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

RNA expression and gene mutation

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Zhuonan Wang, Ph.D.

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 24, 2023
• Study Start: June 15, 2023
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-06

Locations

CN (1)