Trial Outcomes & Findings for Evaluation of Diagnostic Value of 3-T Magnetic Resonance Imaging (MRI) in Suspected Prostate Cancer (NCT NCT01357512)

Results Overview

The number of patients with confirmed prostate cancer among men with MRI performed before biopsies are compared to the number of patients with prostate cancer confirmed in prostate biopsies without MRI. The number patients with prostate cancer are counted as total from cancers detected in random biopsies and in biopsies targeted based on suspicious MRI findings in MRI group, and from random biopsies in no MRI group.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

130 participants

Primary outcome timeframe

at the end of the study (up to 1 year)

Results posted on

2017-12-02

Participant Flow

Participant milestones

Participant milestones
Measure	MRI Done Subjects with MRI prior prostate biopsies magnetic resonance imaging, Siemens: Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device	no MRI No MRI before prostate biopsies
Overall Study STARTED	65	65
Overall Study COMPLETED	53	60
Overall Study NOT COMPLETED	12	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Diagnostic Value of 3-T Magnetic Resonance Imaging (MRI) in Suspected Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MRI Done n=53 Participants Subjects with MRI prior prostate biopsies magnetic resonance imaging, Siemens: Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device	no MRI n=60 Participants No MRI before prostate biopsies	Total n=113 Participants Total of all reporting groups
Age, Continuous	63 years n=5 Participants	62 years n=7 Participants	62 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants	60 Participants n=7 Participants	113 Participants n=5 Participants
Region of Enrollment Finland	53 participants n=5 Participants	60 participants n=7 Participants	113 participants n=5 Participants
Serum prostate-specific antigen level	6.1 ng/ml n=5 Participants	6.2 ng/ml n=7 Participants	6.1 ng/ml n=5 Participants

PRIMARY outcome

Timeframe: at the end of the study (up to 1 year)

The number of patients with confirmed prostate cancer among men with MRI performed before biopsies are compared to the number of patients with prostate cancer confirmed in prostate biopsies without MRI. The number patients with prostate cancer are counted as total from cancers detected in random biopsies and in biopsies targeted based on suspicious MRI findings in MRI group, and from random biopsies in no MRI group.

Outcome measures

Outcome measures
Measure	MRI Done n=53 Participants Subjects with MRI prior prostate biopsies magnetic resonance imaging, Siemens: Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device	no MRI n=60 Participants No MRI before prostate biopsies
Number of Prostate Cancer Diagnoses in MRI and no MRI Groups	34 participants	34 participants

SECONDARY outcome

Timeframe: at the end of the study (up to 1 year)

The number of biopsies with histology confirming prostate cancer are compared between MRI and no MRI groups. This measure will clarify if prostate cancer can be diagnosed more accurately, i.e. more biopsies with confirmed prostate cancer, after MRI. Ten or 12 biopsies will be taken from prostates below 30 grams, or equal or above 30 grams, respectively.

Outcome measures

Outcome measures
Measure	MRI Done n=53 Participants Subjects with MRI prior prostate biopsies magnetic resonance imaging, Siemens: Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device	no MRI n=60 Participants No MRI before prostate biopsies
Number of Positive Biopsies in MRI and no MRI Groups	3.0 number of cancer-positive biopsy cores Interval 2.0 to 5.0	3.0 number of cancer-positive biopsy cores Interval 1.75 to 5.25

SECONDARY outcome

Timeframe: at the end of the study (up to 1 year)

Number of clinically significant prostate cancers detected with and without MRI. Clinically significant prostate cancer is determined by the Gleason grading and be the number of cancer-positive biopsy cores.

Outcome measures

Outcome data not reported

Adverse Events

MRI Done

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

no MRI

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MRI Done n=53 participants at risk Subjects with MRI prior prostate biopsies magnetic resonance imaging, Siemens: Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device	no MRI n=60 participants at risk No MRI before prostate biopsies
Cardiac disorders collapse	0.00% 0/53	1.7% 1/60 • Number of events 1

Additional Information

Chief urologist Markku Vaarala

Oulu University Hospital and Univeristy of Oulu

Phone: +3588315

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place