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

NCT05587192 | Active Not Recruiting DMC

• 1 other identifier: SNOTOB
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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 radical prostatectomy directly if prostate cancer is considered by 18F-PSMA-1007 PET/CT.

Conditions

Prostate Cancer

Keywords

prostate cancer; PSMA-1007; PET-CT; Biopsy; prostate-specific antigen; mpMRI; Diagnosis

Outcome Measures

Primary Outcomes (1)

• Detection rate of clinically significant prostate cancer

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

  Immediately after prostatectomy

Secondary Outcomes (2)

• Detection rate of prostate cancer

  Immediately after prostatectomy

• Detection of high-grade prostate cancer

  Immediately after prostatectomy

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

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

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men with clinically suspected prostate cancer (abnormal DRE or PSA);
• Complete the test of serum PSA and examination of mpMRI;
• 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.

You may not qualify if:

• 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;
• Patients who have negative results in the previous prostate biopsy;
• Patients refuse radical prostatectomy or still choose prostate biopsy.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

The First Affiliated Hospital of USTC

Hefei, Anhui, 230001, China

Location

Related Publications (16)

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• Meissner VH, Rauscher I, Schwamborn K, Neumann J, Miller G, Weber W, Gschwend JE, Eiber M, Heck MM. Radical Prostatectomy Without Prior Biopsy Following Multiparametric Magnetic Resonance Imaging and Prostate-specific Membrane Antigen Positron Emission Tomography. Eur Urol. 2022 Aug;82(2):156-160. doi: 10.1016/j.eururo.2021.11.019. Epub 2021 Dec 6.

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  PMID: 37984956 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tao Tao, MD Ph.D

  The First Affiliated Hospital of USTC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Associate chief physician

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 19, 2022
• Study Start: November 10, 2022
• Primary Completion: December 20, 2023
• Study Completion: June 30, 2024
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)