Trial Outcomes & Findings for High Resolution MRI Study for Prostate Cancer (NCT NCT03292874)

NCT ID: NCT03292874

Last Updated: 2024-04-03

Results Overview

The primary endpoint of the clinical trial was the presence of adverse histology (AH) on prostate biopsy. We defined adverse histology (AH) as either overall Gleason score of 7 or more on any biopsy, or an increase of 3 or more positive cores on serial systematic biopsies. The primary hypothesis was that change in tumor size or apparent diffusion coefficient (ADC) as detected by high resolution MRI (hrMRI) would better predict AH than standard MRI (sMRI). AH histology was a measure intended to capture patients with high Gleason grade component (i.e. Gleason Grade 4 or 5) and patients progressing (e.g. from Gleason Group 1 to Gleason Group 2 or from Gleason Group 2 to Gleason Group 3). The sample size was too small and the followup duration of approximately 12 months was too short to assess only true cancer progression as the endpoint. The presence of AH alone is clinically important since these patients may need close followup and may consider definitive local therapy.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 64 participants
• Primary outcome timeframe: 6-12 months after enrollment
• Results posted on: 2024-04-03

Participant Flow

Participant milestones

Measure	Paired Imaging Single arm, paired imaging of high resolution MRI (hrMRI) and standard MRI (sMRI) high resolution MRI (hrMRI): high resolution MRI (hrMRI) and standard MRI (sMRI) will be obtained at baseline and again in approximately 1 year in patients on prostate cancer active surveillance.
Overall Study STARTED	64
Overall Study COMPLETED	59
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Paired Imaging Single arm, paired imaging of high resolution MRI (hrMRI) and standard MRI (sMRI) high resolution MRI (hrMRI): high resolution MRI (hrMRI) and standard MRI (sMRI) will be obtained at baseline and again in approximately 1 year in patients on prostate cancer active surveillance.
Overall Study Due to pandemic	5

Baseline Characteristics

High Resolution MRI Study for Prostate Cancer

Baseline characteristics by cohort

Measure	Paired Imaging n=59 Participants Single arm, paired imaging of high resolution MRI (hrMRI) and standard MRI (sMRI) high resolution MRI (hrMRI): high resolution MRI (hrMRI) and standard MRI (sMRI) will be obtained at baseline and again in approximately 1 year in patients on prostate cancer active surveillance.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants
Age, Categorical >=65 years	32 Participants n=5 Participants
Age, Continuous	65 years STANDARD_DEVIATION 6.7 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	59 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	57 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	46 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
PSA	6.0 nanograms per milliliter STANDARD_DEVIATION 2.8 • n=5 Participants
Histologic Grade Low grade (Gleason 3+3)	45 Participants n=5 Participants
Histologic Grade Intermediate grade (Gleason 3+4)	14 Participants n=5 Participants
No. positive cores on prostate biopsy	2.9 Number of positive cores STANDARD_DEVIATION 2.4 • n=5 Participants
No. prior biopsies 0	41 Participants n=5 Participants
No. prior biopsies 1	8 Participants n=5 Participants
No. prior biopsies >1	10 Participants n=5 Participants
Stage T1c (non-palpable tumor)	58 Participants n=5 Participants
Stage T2a (palpable tumor)	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6-12 months after enrollment

Population: Each participant underwent both sMRI and hrMRI.

The primary endpoint of the clinical trial was the presence of adverse histology (AH) on prostate biopsy. We defined adverse histology (AH) as either overall Gleason score of 7 or more on any biopsy, or an increase of 3 or more positive cores on serial systematic biopsies. The primary hypothesis was that change in tumor size or apparent diffusion coefficient (ADC) as detected by high resolution MRI (hrMRI) would better predict AH than standard MRI (sMRI). AH histology was a measure intended to capture patients with high Gleason grade component (i.e. Gleason Grade 4 or 5) and patients progressing (e.g. from Gleason Group 1 to Gleason Group 2 or from Gleason Group 2 to Gleason Group 3). The sample size was too small and the followup duration of approximately 12 months was too short to assess only true cancer progression as the endpoint. The presence of AH alone is clinically important since these patients may need close followup and may consider definitive local therapy.

Outcome measures

Measure	High Resolution MRI (hrMRI) n=59 Participants All patients underwent hrMRI and sMRI.	Standard MRI (sMRI) n=59 Participants All patients underwent hrMRI and sMRI.
Sensitivity and Specificity of High Resolution Versus Standard MRI in Identifying Adverse Histology sensitivity	75 percent	71 percent
Sensitivity and Specificity of High Resolution Versus Standard MRI in Identifying Adverse Histology specificity	84 percent	54.8 percent

PRIMARY outcome

Timeframe: 6-12 months after enrollment

Population: Each participant underwent both sMRI and hrMRI. Each was assess for predicting AH.

The primary endpoint of the clinical trial was the presence of adverse histology (AH) on prostate biopsy. We defined adverse histology (AH) as either overall Gleason score of 7 or more on any biopsy, or an increase of 3 or more positive cores on serial systematic biopsies. The primary hypothesis was that change in tumor size or apparent diffusion coefficient (ADC) as detected by high resolution MRI (hrMRI) would better predict AH than standard MRI (sMRI). AH histology was a measure intended to capture patients with high Gleason grade component (i.e. Gleason Grade 4 or 5) and patients progressing (e.g. from Gleason Group 1 to Gleason Group 2 or from Gleason Group 2 to Gleason Group 3). The sample size was too small and the followup duration of approximately 12 months was too short to assess only true cancer progression as the endpoint. The presence of AH alone is clinically important since these patients may need close followup and may consider definitive local therapy.

Outcome measures

Measure	High Resolution MRI (hrMRI) n=59 Participants All patients underwent hrMRI and sMRI.	Standard MRI (sMRI) n=59 Participants All patients underwent hrMRI and sMRI.
Area Under the Receiver Operator Curve of High Resolution Versus Standard MRI in Identifying Adverse Histology	0.794 probability	0.631 probability

Adverse Events

hrMRI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

sMRI

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

Dr. Hyung L Kim

Cedars Sinai Medical Center

Phone: 310-423-4700

Email: kimhl@cshs.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place