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

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

Sponsors

Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Source 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.

Overall Status Not yet recruiting
Start Date December 2019
Completion Date December 2020
Primary Completion Date November 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Detection rate of prostate cancer 30 days post biopsy
Secondary Outcome
Measure Time Frame
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 90 days post biopsy
Optimal cut-off uptake value on PET/MRI for prostate cancer detection 30 days post-biopsy
Enrollment 50
Condition
Intervention

Intervention Type: Device

Intervention Name: multiparametric MRI and 68Ga-PSMA PET/MRI

Description: All participants will undergo multiparametric MRI examination. If mpMRI is unfavorable for prostate cancer, participants will undergo 68Ga-PSMA PET/MRI examination

Arm Group Label: Prostate biopsy with 68Ga-PSMA PET/MRI

Intervention Type: Procedure

Intervention Name: Prostate biopsy

Description: 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

Arm Group Label: Prostate biopsy with 68Ga-PSMA PET/MRI

Eligibility

Criteria:

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.

Gender: Male

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Hongqian Guo, PhD Study Chair The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Overall Contact

Last Name: Hongqian Guo, PhD

Phone: 8613605171690

Phone Ext.: 8613605171690

Email: [email protected]

Verification Date

October 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Investigator Full Name: Hongqian Guo

Investigator Title: Executive officer of Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Prostate biopsy with 68Ga-PSMA PET/MRI

Type: Experimental

Description: Both targeted biopsy and 12-core systematic biopsy with positive 68Ga-PSMA PET/MRI

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov