Prospective intra-individual comparison of the mpMRI versus 68Ga-PSMA11 PET/MRI in a blinded read to evaluate diagnostic accuracy in patients with prostate cancer

JRCT ID: jRCTs022220021

Registered date:15/09/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Prostate Cancer
• Date of first enrollment: 13/10/2022
• Target sample size: 152
• Study type: Interventional
• Intervention(s): 100-200 Mb 68Ga-PSMA-11 qsynthesized by the Ga-68 PSMA automated synthesizer is administered to patients, and PET/MRI is imaged about 60 minutes (50 to 100 minutes) after administration.

Outcome(s)

• Primary Outcome: Comparison of diagnostic accuracy in clinical T staging between 68Ga-PSMA-11 PET/MRI and mpMRI

Secondary Outcome

1. Comparison of diagnostic accuracy in clinical T staging between 68Ga-PSMA-11 PET/MRI and mpMRI for each clinical stage
2. Comparison of diagnostic accuracy in clinical Tstaging between 68Ga-PSMA-11 PET/MRI and mpMRI for each pre-treatment risk group classification of prostate cancer
3. Comparison of sensitivity between 68Ga-PSMA11 PET/MRI and mpMRI in prostate cancer detection
4. Comparison of sensitivity and specificity between 68Ga-PSMA-11 PET/MRI and mpMRI in detection of extracapsular extension and seminal vesicle invasion
5. Diagnostic accuracy in clinical T staging using comprehensive clinical information including 68Ga-PSMA-11 PET/MRI and mpMRI by urologists and radiologists in our hospital
6. Comparison of sensitivity and specificity between 68Ga-PSMA-11 PET/MRI and mpMRI in prostate cancer detection on segment analysis
7. Comparison of sensitivity and specificity between 68Ga-PSMA-11 PET/MRI and mpMRI in prostate cancer detection on segment analysis for each ISUP Gleason grade
8. Comparison of sensitivity and specificity between 68Ga-PSMA-11 PET/MRI and mpMRI in detection of lymph node metastasis
9. Percentage of patients with bone metastases identified by 68Ga-PSMA-11 PET/MRI and additional MRI
10. Impact on further treatment decision by 68Ga-PSMA-11 PET/MRI and mpMRI
11. Inter-rater reliability of the primary endpoint and secondary endpoints (1-4, 6-9)

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Male

Include criteria

1) Patients who have given written consent to participate in the study
2) Prostate cancer patients diagnosed with adenocarcinoma by prostate biopsy
3) Patients aged 40 or over at the time of registration
4) Untreated prostate cancer patients
5) Patients who are scheduled to undergo radical prostatectomy as curative treatment

Exclude criteria

1) Patients with obvious distant metastasis by CT /bone scintigraphy.
2) Patients who are ineligible for MRI examination, such as having a metal-containing medical device embedded in their body and claustrophobia.
3) Patients with other active cancers other than prostate cancer.
4) Patients with contrast medium allergy to gadolinium.
5) Patients who are judged by the principal investigator to be inappropriate for inclusion in the study.

Related Information

• Primary Sponsor: Kojima Yoshiyuki
• Source(s) of Monetary Support: Tokiwakai group