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

Not Applicable

• Conditions: Prostate Neoplasm
• Interventions: Device: multiparametric MRI and 68Ga-PSMA PET/MRI; Procedure: Prostate biopsy

• Registration Number: NCT04124107
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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.

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-10
• Study First Submitted QC: 2019-10-10
• Last Update Submitted: 2019-10-10
• Study First Posted: 2019-10-11
• Last Update Posted: 2019-10-14
• Study Start: 2019-12
• Primary Completion: 2020-11
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prostate biopsy with 68Ga-PSMA PET/MRI	Prostate biopsy	Both targeted biopsy and 12-core systematic biopsy with positive 68Ga-PSMA PET/MRI
Prostate biopsy with 68Ga-PSMA PET/MRI	multiparametric MRI and 68Ga-PSMA PET/MRI	Both targeted biopsy and 12-core systematic biopsy with positive 68Ga-PSMA PET/MRI

Primary Outcome Measures

Name	Time	Method
Detection rate of prostate cancer	30 days post biopsy	Detection rate of prostate cancer

Secondary Outcome Measures

Name	Time	Method
Detection rates of clinically significant PCa and clinically insignificant prostate cancer	30 days post biopsy	Detection rates of clinically significant PCa and clinically insignificant prostate cancer
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	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
Optimal cut-off uptake value on PET/MRI for prostate cancer detection	30 days post-biopsy	Optimal cut-off uptake value on PET/MRI for prostate cancer detection