Unfavorable MRI But Favorable 68Ga-PSMA PET/MRI for Primary Prostate Cancer Detection

NCT ID: NCT04124107

Last Updated: 2019-10-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-31
• Study Completion Date: 2020-12-31

Brief Summary

This perspective cohort study aims to assess the detection rate of prostate cancer through prostate biopsy within suspicious patients harboring unfavorable multiparametric MRI but favorable 68Ga-PSMA PET/MRI who have had no prior prostate biopsy.

Detailed Description

Multiparametric MRI (MpMRI) is currently regarded as the best imaging method to noninvasively identify and characterize prostate cancer (PCa) with the Prostate Imaging Reporting and Data System (PI-RADS) v2. However, there are diagnostic difficulties for suspicious patients with PI-RADS score 3 and not all PCa are equivalently visible on mpMRI. For such patients, other alternative imaging techniques are required to properly characterize and detect PCa.

It has been widely reported that 68Ga-PSMA PET imaging offers excellent performance in detecting primary PCa and is able to noninvasively characterize the aggressiveness of PCa. Recently, integrated PET/MRI, which combines the strengths of both modalities, has been shown to have great potential for influencing clinical practice by providing a more certain map of localized PCa to aid targeted biopsies and therapy.

This perspective cohort study aims to assess the detection rate of PCa through prostate biopsy within suspicious patients harboring unfavorable mpMRI but favorable 68Ga-PSMA PET/MRI who have had no prior prostate biopsy.

Conditions

Prostate Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Prostate biopsy with 68Ga-PSMA PET/MRI

Both targeted biopsy and 12-core systematic biopsy with positive 68Ga-PSMA PET/MRI

Group Type: EXPERIMENTAL

multiparametric MRI and 68Ga-PSMA PET/MRI

Intervention Type: DEVICE

All participants will undergo multiparametric MRI examination. If mpMRI is unfavorable for prostate cancer, participants will undergo 68Ga-PSMA PET/MRI examination

Prostate biopsy

Intervention Type: PROCEDURE

Participants with unfavorable mpMRI but favorable 68Ga-PSMA PET/MRI will undergo both 68Ga-PSMA PET/MRI-ultrasound-fusion targeted biopsy and transperineal ultrasound guided 12-core systematic biopsy

Interventions

multiparametric MRI and 68Ga-PSMA PET/MRI

All participants will undergo multiparametric MRI examination. If mpMRI is unfavorable for prostate cancer, participants will undergo 68Ga-PSMA PET/MRI examination

Intervention Type: DEVICE

Prostate biopsy

Participants with unfavorable mpMRI but favorable 68Ga-PSMA PET/MRI will undergo both 68Ga-PSMA PET/MRI-ultrasound-fusion targeted biopsy and transperineal ultrasound guided 12-core systematic biopsy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Men more than 18 years old with clinical suspicion of prostate cancer;

2. Serum prostate-specific antigen (PSA) > 4 ng/ml within the previous 3 months;

3. PI-RADS score no more than 3 or normal mpMRI of prostate;

4. Suspicious lesion(s) within prostate on 68Ga-PSMA PET/MRI;

5. no evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis;

6. Able to provide written informed consent.

Exclusion Criteria

1. Prior prostate biopsy or prostate surgery;

2. Prior treatment for prostate cancer;

3. Contraindication to MRI or PET (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min);

4. Contraindication to prostate biopsy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role: lead

Responsible Party

Hongqian Guo

Executive officer of Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hongqian Guo, PhD

Role: STUDY_CHAIR

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Central Contacts

Hongqian Guo, PhD

Role: CONTACT

dr.ghq@nju.edu.cn

8613605171690 ext. 8613605171690

Jie Gao, Bachelor

Role: CONTACT

medgaojie@163.com

8613951784909 ext. 8613605171690

Other Identifiers

PET+/MRI- v1.0 20191010

Identifier Type: -

Identifier Source: org_study_id