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

Prostate Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04124107
• Other study ID #: PET+/MRI- v1.0 20191010
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2019
• Est. completion date: December 2020

Study information

• Verified date: October 2019
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Hongqian Guo, PhD
• Phone: 8613605171690
• Email: dr.ghq[@]nju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Neoplasm
• Prostatic Neoplasms

Intervention

Device:
• multiparametric 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

Procedure:
• Prostate 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection rate of prostate cancer	Detection rate of prostate cancer	30 days post biopsy
Secondary	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
Secondary	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
Secondary	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