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

July 14, 2023 updated by: First Affiliated Hospital Xi'an Jiaotong University

Application Value of Biopsy Free Technique for Prostate Specific Antigen Grey Area Prostate Cancer Based on 18F-Prostate Specific Membrane Antigen-1007 Positron Emission Tomography/Computerized Tomography

The goal of this observational study is to establish an evaluation system for accurate identification of prostate cancer and prostatic hyperplasia 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; develop a nomogram of biomarkers (PSA) + imaging (PSMA) to predict the likelihood of clinically significant prostate cancer in men pre-biopsy.

Participants will: 1. undergo PSMA PET/CT and multiparameter MRI; 2. undergo biopsy; and 3. undergo radical prostatectomy for biopsy-proven clinically significant prostate cancer.

Researchers will compare the PSMA PET/CT-based features between prostate cancer and benign prostatic hyperplasia to see if there are differences in semiquantitative parameters.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Prostate Specific Antigen (PSA) is a serine protease secreted by prostate epithelial cells, which is a tumor marker of prostate cancer. At present, PSA<4 ng/ml is considered as the normal value, and PSA 4-10 ng/ml is considered as the gray value. PSA>10 ng/ml should be highly suspected of prostate cancer. Prostate biopsy is still the gold standard for the diagnosis of prostate cancer. However, as an invasive procedure, it can cause many complications such as pain, bleeding, lower urinary tract symptoms and infection. There is a growing trend to reduce unnecessary prostate biopsies.

Prostate specific membrane antigen (PSMA) is a membrane-bound enzyme that is highly expressed in more than 90% of prostate cancer lesions and has become an important target for molecular imaging of prostate cancer. In recent years, radioactive nuclide 18F labeling targeting PSMA positron emission tomography/computed tomography (PET/CT) has shown important clinical application value in prostate cancer recurrence monitoring.

The goal of this observational study is to establish an evaluation system for accurate identification of prostate cancer and prostatic hyperplasia in patients in the PSA gray zone.

Participants will: 1. undergo PSMA PET/CT and multiparameter MRI; 2. undergo biopsy; and 3. undergo radical prostatectomy for biopsy-proven clinically significant prostate cancer.

Researchers will compare the PSMA PET/CT-based features between prostate cancer and benign prostatic hyperplasia to see if there are differences in semiquantitative parameters.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • First Affiliated Hospital of Xi'an JiaoTong University
        • Contact:
          • Zhuonan Wang, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • PSA (4-20ng/mL)
  • Abnormal digital rectal examination
  • MRI and PSMA-PET-CT were not contraindicated
  • Did not receive prostate-related treatment
  • There are no contraindications to biopsy

Exclusion Criteria:

  • Coexisting with other malignancies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Benign Prostatic Hyperplasia
Participants who are suspected of prostate cancer due to elevated PSA but have not received any treatment and eventually confirmed benign prostatic hyperplasia 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
Procedure: Radical prostatectomy (RP)
Radical prostatectomy will be done by experienced urologists using Da Vinci Xi robotic surgical system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of SUVmax
Time Frame: From the time the participants first go to the hospital without treatment and through study completion, an average of 1 year. If the patient undergoes radical prostatectomy, an additional scan will be added within 3-6 months after surgery
Maximum Standardized Uptake Value (SUVmax) is the most commonly used semi-quantitative parameter in PET/CT, which is used to assess tumor burden of PCa.
From the time the participants first go to the hospital without treatment and through study completion, an average of 1 year. If the patient undergoes radical prostatectomy, an additional scan will be added within 3-6 months after surgery
PSA
Time Frame: Through study completion, an average of 1 year
Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are usually reported as nanograms of PSA per milliliter (ng/mL) of blood.
Through study completion, an average of 1 year
Gleason Score of Biopsy
Time Frame: Within one week after prostate cancer biopsies
The cells are graded on a scale of 1 to 5. Grade 1 cells resemble normal prostate tissue. Cells closest to 5 are considered "high-grade" and have mutated so much that they barely resemble normal cells.
Within one week after prostate cancer biopsies
Gleason Score of Radical Prostatectomy
Time Frame: Within one week after prostate cancer biopsies
The cells are graded on a scale of 1 to 5. Grade 1 cells resemble normal prostate tissue. Cells closest to 5 are considered "high-grade" and have mutated so much that they barely resemble normal cells.
Within one week after prostate cancer biopsies

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Study Chair: Zhuonan Wang, Ph.D., First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2023

Primary Completion (Estimated)

May 20, 2025

Study Completion (Estimated)

May 20, 2025

Study Registration Dates

First Submitted

July 6, 2023

First Submitted That Met QC Criteria

July 14, 2023

First Posted (Estimated)

July 24, 2023

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 14, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF2023LSK-367

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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