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

Diagnostic Performance of 68Ga-PSMA PET/MRI in Suspicious Biopsy-naive Prostate Cancer Patients With Favorable Lesion on PET But Unfavorable on MRI for Primary Prostate Cancer Detection: a Pilot Study

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.

Study Overview

• Status: Unknown
• Conditions: Prostate Neoplasm
• Intervention / Treatment: Device: multiparametric MRI and 68Ga-PSMA PET/MRI; Procedure: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hongqian Guo, PhD; Phone Number: 8613605171690 8613605171690; Email: dr.ghq@nju.edu.cn
• Study Contact Backup: Name: Jie Gao, Bachelor; Phone Number: 8613605171690 8613951784909; Email: medgaojie@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Device: 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; Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection rate of prostate cancer	Detection rate of prostate cancer	30 days post biopsy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection rates of clinically significant PCa and clinically insignificant prostate cancer	Detection rates of clinically significant PCa and clinically insignificant prostate cancer	30 days post biopsy
Gleason grade group distribution (score from 1 to 5, the bigger the score, the worse the prognosis) and aggressive architecture (such as cribriform) on final pathology	Gleason grade group distribution (score from 1 to 5, the bigger the score, the worse the prognosis) and aggressive architecture (such as cribriform) on final pathology	90 days post biopsy
Optimal cut-off uptake value on PET/MRI for prostate cancer detection	Optimal cut-off uptake value on PET/MRI for prostate cancer detection	30 days post-biopsy

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2019
• Primary Completion (ANTICIPATED): November 1, 2020
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: October 10, 2019
• First Submitted That Met QC Criteria: October 10, 2019
• First Posted (ACTUAL): October 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 14, 2019
• Last Update Submitted That Met QC Criteria: October 10, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Gallium 68 PSMA-11
• Other Study ID Numbers: PET+/MRI- v1.0 20191010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No