Radical Prostatectomy Without Prostate Biopsy Following PSMA PET/CT Based on Diagnostic Model (RPWPB)

February 8, 2024 updated by: TaoTao, Anhui Provincial Hospital

Radical Prostatectomy Without Prostate Biopsy Following 18F-PSMA-1007 PET/CT Based on a Diagnostic Model: a Single-center, Single-arm, Open-label Study

The goal of this prospective, single-center, single-arm trial is to evaluate the positive predictive values between 18F-PSMA-1007 PET/CT based on diagnostic model in patients with suspicious of prostate cancer. The main question and our aim to answer is:

• Can these patients with clinically significant prostate cancer in 18F-PSMA-1007 PET/CT based on diagnostic model undergo radical prostatectomy directly without prostate biopsy.

Participants will be asked to accomplish the test of serum PSA, mpMRI, then, the eligible patients (The probability of the diagnostic model to predict clinically significant prostate cancer was greater than or equal to 60 percent) need perform 18F-PSMA-1007 PET/CT. Finally, patients will receive radical prostatectomy directly if prostate cancer is considered by 18F-PSMA-1007 PET/CT.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Study Design and Setting SNOTOB study is a prospective, single-center, single-arm and open-label clinical study and conducted in the First Affiliated Hospital of USTC in China. Patients who have no surgical contraindications and meet the enrollment criteria will be recruited to the study. Subsequently, we will recommend these patients to accept radical prostatectomy without prostate biopsy directly. Before the operation, patients and their family member will be fully informed of the surgical risks, the necessity to perform a prostate biopsy for pathologic confirmation, the possibility of benign prostatic disease and the other alternative therapeutic methods including active surveillance, radiotherapy, and focal therapies and so on. Finally, the diagnostic performance of our noninvasive diagnostic strategy will be verified with the pathological results.

Screening and Enrollment The noninvasive diagnostic strategy in this study consists of a prostate cancer diagnostic model and 18F-prostate-specific membrane antigen-1007 positron emission tomography/computed tomography (18F-PSMA-1007 PET/CT) examination in series. After the patients complete the serum prostate-specific antigen (PSA) test and multiparameter magnetic resonance imaging (mpMRI), we can obtain the information of prostate-specific antigen density (PSAD) and prostate imaging-reporting and data system version 2.1 (PI-RADS v2.1) score. Then, patients' risk probability of clinically significant prostate cancer (csPCa) will be calculated by the online diagnostic nomogram (website: https://ustcprostatecancerprediction.shinyapps.io/dynnomapp/). When the prediction probability of csPCa is equal or greater than 0.60, 18F-PSMA-1007 PET/CT will be applied for further diagnosis. If patients are still considered as csPCa after 18F-PSMA-1007 PET/CT examinations, we define this condition as positive result of our noninvasive diagnostic strategy. These patients meet our criteria of this study. Of note, patients with prediction probability less than 0.60 will no longer undergo 18F-PSMA-1007 PET/CT examinations, and patients with risk probability equal or greater than 0.60 but negative 18F-PSMA-1007 PET/CT examinations will not meet the enrollment criteria too.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

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 Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230001
        • The First Affiliated Hospital OF USTC
        • Contact:
        • Principal Investigator:
          • Tao Tao, MD 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Men with clinically suspected prostate cancer (abnormal DRE or PSA);
  2. Complete the test of serum PSA and examination of mpMRI;
  3. 4 ng/ml ≤serum total PSA<100ng/ml;
  4. The probability of the diagnostic model to predict clinically significant prostate cancer was greater than or equal to 60 percent;
  5. Prostate cancer is considered by 18F-PSMA-1007 PET/CT;
  6. Meet the surgical indications for radical prostatectomy.

Exclusion Criteria:

  1. Incomplete information of serum PSA tests or mpMRI;
  2. serum total PSA<4ng/ml or ≥ 100 ng/ml;
  3. The probability of the diagnostic model to predict clinically significant prostate cancer was less than 60 percent;
  4. Prostate cancer is not considered by 18F-PSMA-1007 PET/CT;
  5. Patients who have negative results in the previous prostate biopsy;
  6. Patients refuse radical prostatectomy or still choose prostate biopsy.

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 18F-PSMA-1007 PET/CT based on USTC diagnostic model
Patinets will complete the 18F-PSMA-1007 PET/CT based USTC diagnostic model firstly. If clinically significant prostate cancer is considered by 18F-PSMA-1007 PET/CT. Patinets will receive radical prostatectomy directly or undergo prostate biopsy according to patients own decisions, patients with negative results in prostate biopsy will be asked to complete rebiopsy after 3 months.
Diagnostic test: 18F-PSMA-1007 PET/CT based on diagnostic model
All enrolled patients will receive 18F-PSMA-1007 PET/CT based USTC diagnostic model before gaining the final pathological diagnosis to be used as experimental arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection rate of clinically significant prostate cancer
Time Frame: Immediately after prostatectomy
Detection rate of clinically significant prostate cancer which defined as Gleason score ≥ 3+4.
Immediately after prostatectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection rate of prostate cancer
Time Frame: Immediately after prostatectomy
Detection rate of prostate cancer which defined as Gleason score ≥ 3+3.
Immediately after prostatectomy
Detection of high-grade prostate cancer
Time Frame: Immediately after prostatectomy
Detection of high-grade prostate cancer which defined as Gleason score ≥ 4+3.
Immediately after prostatectomy

Collaborators and Investigators

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

Sponsor

Anhui Provincial Hospital

Investigators

  • Study Chair: Tao Tao, MD Ph.D, The First Affiliated Hospital OF USTC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 10, 2022

Primary Completion (Actual)

December 20, 2023

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

October 17, 2022

First Submitted That Met QC Criteria

October 17, 2022

First Posted (Actual)

October 19, 2022

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNOTOB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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