The Value of MultiSpectral 3 Tesla MRI in Active Surveillance of Prostate Cancer

To Determine if MultiSpectral 3 Tesla MRI Can Provide Added Value in the Detection of Significant Cancers in Patients o n Active Surveillance for Prostate Cancer

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01896713

Enrollment

Registered

2013-07-11

Start date

2010-04-30

Completion date

2012-12-31

Last updated

2013-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostate Cancer, MRI, TRUSBx

Brief summary

MultiSpectral 3 Tesla MRI (MS3TMRI) can increase the yield of Trans Rectal Ultrasound Biopsy (TRUSBx) to improve identification of patients on active surveillance requiring treatment.

Detailed description

This is a prospective single arm study. 120 patients at risk for significant occult prostate cancer on an active surveillance program will undergo MS3TMRI followed by a standard TRUSBx and additional biopsies guided by the MS3TMRI results. The positive predictive value (PPV) of MS3TMRI-TRUSBx for cancer requiring consideration of therapy will be compared to the PPV of TRUSBx alone. MS3TMRI consists of T2, diffusion-weighted imaging (DWI), dynamic contrast enhanced MRI (DCEMRI), proton MR spectroscopy (MRS) interpreted by a radiologist and by CAD methods validated on whole mount prostate specimens.

Interventions

OTHERMS3TMRI

Multispectral 3 Tesla MRI imaging with contrast followed by biopsy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Enrolled in active surveillance at Sunnybrook Health Sciences Centre, requiring biopsy as part of surveillance protocol. * Clinically eligible for radical prostatectomy and willing to undergo surgery * Clinically eligible for and willing to undergo ultrasound biopsy within 8 weeks of MRI

Exclusion criteria

* Claustrophobia * Contraindication to MRI * Contraindication to receiving low molecular weight MRI contrast agent * Prior hormone therapy except 5-alpha reductase inhibitors such as Avodart. FloMax etc * Clinically suspected or known compromised renal function or calculated estimated Glomerular Filtration Rate (eGFR) \<30ml/min

Design outcomes

Primary

Measure	Time frame	Description
The Positive Predictive Value (PPV) of MS3TMRI-TRUSBx for detection of a patient with a cancer burden requiring consideration of immediate therapy.	The outcome measure will be evaluated at the time of the results of the TRUSbx which will be approximately 2 weeks after the biopsy	Compare the targeted biopsy to the random biopsies

Secondary

Measure	Time frame
The number of cores required for diagnosis of prostate cancer for MS3TMRI-TRUSBx versus TRUSBx alone	The outcome measure will be evaluated at the time of the results of the TRUSbx which will be approximately 2 weeks after the biopsy

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026