Trial Outcomes & Findings for Transrectal MRI-Guided Biopsy in Identifying Cancer in Patients With Suspected Prostate Cancer (NCT NCT02501759)

Results Overview

The proportion of MRI-guided biopsies that demonstrate a higher Gleason score than contemporaneous TRUS guided biopsy for all patients diagnosed of prostate cancer based on the reference standard will be estimated. McNemar's test will be used to assess whether the MRI-guided biopsies are more likely to yield a higher Gleason score compared with TRUS guided biopsy. Simple logistic regression model will be used to assess the association between the higher Gleason score and patient characteristics and/or clinical information for patients diagnosed of prostate cancer.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

Up to 42 days (6 weeks)

Results posted on

2019-04-03

Participant Flow

Participant milestones

Participant milestones
Measure	Diagnostic (MRI, MRI-guided Biopsy, TRUS-guided Biopsy) Patients receive gadodiamide IV and undergo a diagnostic multiparametric endorectal MRI. Patients with lesions visible on the diagnostic multiparametric endorectal MRI undergo transrectal MRI-guided biopsy within 2 weeks of diagnostic multiparametric endorectal MRI. Patients then undergo TRUS-guided biopsy per standard clinical care approximately 2 weeks after transrectal MRI-guided biopsy. 3 Tesla Magnetic Resonance Imaging: Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast Gadodiamide: Given IV Multiparametric Magnetic Resonance Imaging: Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast Transrectal Biopsy: Undergo transrectal MRI-guided biopsy Ultrasound-Guided Prostate Biopsy: Undergo TRUS-guided biopsy
Overall Study STARTED	2
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transrectal MRI-Guided Biopsy in Identifying Cancer in Patients With Suspected Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diagnostic (MRI, MRI-guided Biopsy, TRUS-guided Biopsy) n=2 Participants Patients receive gadodiamide IV and undergo a diagnostic multiparametric endorectal MRI. Patients with lesions visible on the diagnostic multiparametric endorectal MRI undergo transrectal MRI-guided biopsy within 2 weeks of diagnostic multiparametric endorectal MRI. Patients then undergo TRUS-guided biopsy per standard clinical care approximately 2 weeks after transrectal MRI-guided biopsy. 3 Tesla Magnetic Resonance Imaging: Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast Gadodiamide: Given IV Multiparametric Magnetic Resonance Imaging: Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast Transrectal Biopsy: Undergo transrectal MRI-guided biopsy Ultrasound-Guided Prostate Biopsy: Undergo TRUS-guided biopsy
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 42 days (6 weeks)

Population: Due to low enrollment, insufficient data was collected to report this outcome

The proportion of MRI-guided biopsies that demonstrate a higher Gleason score than contemporaneous TRUS guided biopsy for all patients diagnosed of prostate cancer based on the reference standard will be estimated. McNemar's test will be used to assess whether the MRI-guided biopsies are more likely to yield a higher Gleason score compared with TRUS guided biopsy. Simple logistic regression model will be used to assess the association between the higher Gleason score and patient characteristics and/or clinical information for patients diagnosed of prostate cancer.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 2 weeks after diagnostic MRI

Population: Due to low enrollment, insufficient data was collected to report this outcome

The presence of cancer on either biopsy or absence of cancer on both will be used as the reference standard. For comparison of the two methods, the 2X2 matched sample tables will be presented, and the difference in sensitivity estimated. The relative accuracy of MRI- versus TRUS-guided biopsy will be compared using McNemar's test. To explore potential associations between the accuracy of each method with patient characteristics and/or clinical information, a binary endpoint will be created to reflect agreement between each method and the reference standard.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 2 weeks after MRI-guided biopsy

Population: Due to low enrollment, insufficient data was collected to report this outcome

The presence of cancer on either biopsy or absence of cancer on both will be used as the reference standard. For comparison of the two methods, the 2X2 matched sample tables will be presented, and the difference in sensitivity estimated. The relative accuracy of MRI- versus TRUS-guided biopsy will be compared using McNemar's test. To explore potential associations between the accuracy of each method with patient characteristics and/or clinical information, a binary endpoint will be created to reflect agreement between each method and the reference standard.

Outcome measures

Outcome data not reported

Adverse Events

Diagnostic (MRI, MRI-guided Biopsy, TRUS-guided Biopsy)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Fegus Coakley

OHSU Knight Cancer Institute

Phone: 503-494-2333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place