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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
18F-PSMA-1007 PET/CT based on diagnostic model
Sponsored by
Anhui Provincial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring prostate cancer, PSMA-1007, PET-CT, Biopsy, prostate-specific antigen, mpMRI, Diagnosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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 65 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 65 percent;
  4. Prostate cancer is not considered by 18F-PSMA-1007 PET/CT;
  5. Have surgical contraindications for radical prostatectomy.

Sites / Locations

  • The First Affiliated Hospital of USTC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-PSMA-1007 PET/CT based on USTC diagnostic model

Arm Description

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.

Outcomes

Primary Outcome Measures

Detection rate of clinically significant prostate cancer
Detection rate of clinically significant prostate cancer which defined as Gleason score ≥ 3+4.

Secondary Outcome Measures

Detection rate of prostate cancer
Detection rate of prostate cancer which defined as Gleason score ≥ 3+3.
Detection of high-grade prostate cancer
Detection of high-grade prostate cancer which defined as Gleason score ≥ 4+3.

Full Information

First Posted
October 17, 2022
Last Updated
October 4, 2023
Sponsor
Anhui Provincial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05587192
Brief Title
Radical Prostatectomy Without Prostate Biopsy Following PSMA PET/CT Based on Diagnostic Model
Acronym
RPWPB
Official Title
Radical Prostatectomy Without Prostate Biopsy Following 18F-PSMA-1007 PET/CT Based on USTC Diagnostic Model: a Single-center, Single-arm, Open-label Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Actual)
Study Completion Date
September 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Anhui Provincial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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 prostate biopsy or radical prostatectomy directly according to their decisions if prostate cancer is considered by 18F-PSMA-1007 PET/CT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, PSMA-1007, PET-CT, Biopsy, prostate-specific antigen, mpMRI, Diagnosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
18F-PSMA-1007 PET/CT based on USTC diagnostic model
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
18F-PSMA-1007 PET/CT based on diagnostic model
Intervention Description
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.
Primary Outcome Measure Information:
Title
Detection rate of clinically significant prostate cancer
Description
Detection rate of clinically significant prostate cancer which defined as Gleason score ≥ 3+4.
Time Frame
Immediately after prostatectomy
Secondary Outcome Measure Information:
Title
Detection rate of prostate cancer
Description
Detection rate of prostate cancer which defined as Gleason score ≥ 3+3.
Time Frame
Immediately after prostatectomy
Title
Detection of high-grade prostate cancer
Description
Detection of high-grade prostate cancer which defined as Gleason score ≥ 4+3.
Time Frame
Immediately after prostatectomy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men with clinically suspected prostate cancer (abnormal DRE or PSA); Complete the test of serum PSA and examination of mpMRI; 4 ng/ml ≤serum total PSA<100ng/ml; The probability of the diagnostic model to predict clinically significant prostate cancer was greater than or equal to 60 percent; Prostate cancer is considered by 18F-PSMA-1007 PET/CT; Meet the surgical indications for radical prostatectomy. Exclusion Criteria: Incomplete information of serum PSA tests or mpMRI; serum total PSA<4ng/ml or ≥ 100 ng/ml; The probability of the diagnostic model to predict clinically significant prostate cancer was less than 60 percent; Prostate cancer is not considered by 18F-PSMA-1007 PET/CT; Have surgical contraindications for radical prostatectomy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tao Tao, MD Ph.D
Organizational Affiliation
The First Affiliated Hospital of USTC
Official's Role
Study Chair
Facility Information:
Facility Name
The First Affiliated Hospital of USTC
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
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Radical Prostatectomy Without Prostate Biopsy Following PSMA PET/CT Based on Diagnostic Model

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