MRI-Ultrasound Fusion or Cognitive Registration in MR-targeted Prostate Biopsy

Prostate Cancer Clinical Trial

— PROMUC  

Official title:

PROMUC Trial-Comparison of Magnetic Resonance Imaging-Ultrasound Fusion and Cognitive Registration in MR-targeted Prostate Biopsy: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04953351
• Other study ID #: MRITB-202003
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2021
• Est. completion date: July 2022

Study information

• Verified date: July 2021
• 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 randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of MRI-ultrasound fusion targeted biopsy compared to cognitive registration targeted biopsy in men with clinical suspicion of prostate cancer who had no prior prostate biopsy.

Description:

Prostate biopsy with multiple samples using a standardized template (standard biopsy, SB) under transrectal ultrasound (TRUS) guidance is the current standard diagnostic approach in suspicion of prostate cancer (PCa). However, many biopsies are unnecessary or cannot detect clinically significant PCa (csPCa).

With the introduction of multiparametric magnetic resonance imaging (mpMRI) of the prostate and the improvement for PCa detection and localization, an alternative procedure, known as MRI-targeted biopsy (MRI-TB), has been shown comparable or even higher detection rates of csPCa compared to TRUS-system biopsy (SB). MRI-ultrasound fusion TB (FUS-TB) and cognitive registration TB (COG-TB) are two techniques of MRI-TB commonly used. However, the optimal methodology for targeting MRI-suspicious regions remains unknown. The accuracy of COG-TB compared with FUS-TB remains unclear.

This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of COG-TB compared to FUS-TB (transperineal) in men referred with clinical suspicion of prostate cancer who have had no prior prostate biopsy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 470
• Est. completion date: July 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Men more than 18 years old with clinical suspicion of prostate cancer;

2. Serum PSA = 20 ng/ml within the previous 3 months;

3. Suspected stage = T2 on rectal examination (organ-confined prostate cancer) within the previous 3 months;

4. No evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis;

5. mpMRI PI-RADS V2.1 score =3;

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 (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate = 50mls/min);

4. Contraindication to prostate biopsy;

5. Men in whom artifact would reduce the quality of the MRI.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Cognitive registration targeted biopsy and TRUS-system biopsy
Cognitive registration is a visual guidance technique in which the surgeon samples a visually estimated location on ultrasound that corresponds to the MRI suspicious regions location. TRUS-system biopsy includes 12 biopsy cores.
• MRI-ultrasound fusion targeted biopsy and TRUS-system biopsy
MRI-ultrasound fusion targeted biopsy is conducted with an mpMRI-TRUS biopsy system that provides realtime fusion of TRUS images and MRI images to guide the biopsy needles. TRUS-system biopsy includes 12 biopsy cores.

Locations

Country	Name	City	State
China	Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University	Nanjing	Jiangsu

Sponsors (1)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection rates of clinically significant PCa in FUS-TB and COG-TB		When histology results available, at an expected average of 30 days post-biopsy
Secondary	Detection rates of clinically insignificant PCa in FUS-TB and COG-TB		When histology results available, at an expected average of 30 days post-biopsy
Secondary	Detection rates of clinically insignificant PCa in men with MRI score 3, 4 or 5		When histology results available, at an expected average of 30 days post-biopsy
Secondary	Cancer core length of the most involved biopsy core (maximum cancer core length)		When histology results available, at an expected average of 30 days post-biopsy
Secondary	Biopsy-related adverse events		30 days post biopsy
Secondary	Proportion of men undergoing radical prostatectomy who have Gleason grade upgrading		60 days post biopsy
Secondary	Detection rates of clinically significant PCa in SB		When histology results available, at an expected average of 30 days post-biopsy