Effectiveness of 68Ga-PSMA PET/MRI for Improving the Detection of csPCa in Lesions With PI-RADS Score 3

Effectiveness of 68Ga-PSMA PET/MRI for Improving the Detection of Clinical Significant Prostate Cancer in Lesions With Prostate Imaging Reporting and Data System Score 3

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04573179

Enrollment

Registered

2020-10-05

Start date

2020-07-01

Completion date

2021-07-01

Last updated

2020-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Neoplasms

Brief summary

The purpose of this study was to explore the effectiveness of 68Ga-PSMA PET/MRI for improving the detection of csPCa in lesions with PI-RADS score 3. This study is a prospective, observational study, single-center research. After recruiting patients who are suspected prostate cancer with a mpMRI PI-RADS version2 score of 3 and willing to perform prostate biopsy to identify the diagnosis, 68Ga-PSMA PET/MRI will be performed. Lesions will be reaccessed based on PET/MRI findings and compared with the pathological results.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* males over 18 years old suspected for prostate cancer * serum PSA between 4ng/ml and 20ng/ml in recent two months * mpMRI PI-RADS version2 scores 3 in recent two months * willing to undertake prostate biopsy * no evidence of non-cancerous factors interfere PSA level, such as catheter insertion, bladder stones, urinary tract infections or drug (e.g. finasteride) * ECOG 0-1

Exclusion criteria

* history of prostate biopsy or other operations * history of prostate cancer associated treatment * contraindications for MRI or PET examination (e.g. claustrophobia, pacemakers, hip metal implants, hyperglycemia, glomerular filtration rate less than 50 ml/min) * not suitable for prostate biopsy (e.g. coagulation dysfunction, skin infection at perineal puncture site)

Design outcomes

Primary

Measure	Time frame	Description
detection rate	one year	detection rate of csPCa

Secondary

Measure	Time frame	Description
detection rate	one year	detection rate of non-csPCa

Countries

China

Contacts

Primary ContactHongqian Guo

dr.ghq@nju.edu.cn13605171690

Outcome results