Prostate Neoplasm
Conditions
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.
Interventions
DEVICEmultiparametric 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
PROCEDUREProstate 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
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection rate of prostate cancer | 30 days post biopsy | Detection rate of prostate cancer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary ContactHongqian Guo, PhD
Backup ContactJie Gao, Bachelor
Outcome results
None listed