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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Prostate Neoplasm

Intervention / Treatment
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* Device: multiparametric MRI and 68Ga-PSMA PET/MRI
* Procedure: Prostate biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men more than 18 years old with clinical suspicion of prostate cancer; Serum prostate-specific antigen (PSA) > 4 ng/ml within the previous 3 months; PI-RADS score no more than 3 or normal mpMRI of prostate; Suspicious lesion(s) within prostate on 68Ga-PSMA PET/MRI; no evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis; Able to provide written informed consent. Exclusion Criteria: Prior prostate biopsy or prostate surgery; Prior treatment for prostate cancer; Contraindication to MRI or PET (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min); Contraindication to prostate biopsy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prostate biopsy with 68Ga-PSMA PET/MRI<br>Both targeted biopsy and 12-core systematic biopsy with positive 68Ga-PSMA PET/MRI | Device: multiparametric MRI and 68Ga-PSMA PET/MRI<br>* All participants will undergo multiparametric MRI examination. If mpMRI is unfavorable for prostate cancer, participants will undergo 68Ga-PSMA PET/MRI examination<br>Procedure: Prostate biopsy<br>* 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<br>|

What is the study measuring?
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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 |