High Resolution MRI Study for Prostate Cancer

NCT03292874 | Completed Results FDA Device

• 1 other identifier: Pro00049177
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This high resolution MRI (hrMRI), along with stand MRI (sMRI) will be obtained at baseline and again in approximately 1 year in patients on prostate cancer active surveillance. Changes in lesion size and ADC values will be assessed on the serial studies. This study evaluates the hypothesis that hrMRI will detect changes that sMRI cannot detect and that these changes will correlate with prostate cancer progression as determined on prostate biopsy.

Conditions

Prostate Cancer

Keywords

prostate cancer; MRI

Outcome Measures

Primary Outcomes (2)

• Sensitivity and Specificity of High Resolution Versus Standard MRI in Identifying Adverse Histology

  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.

  6-12 months after enrollment

• Area Under the Receiver Operator Curve of High Resolution Versus Standard MRI in Identifying Adverse Histology

  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.

  6-12 months after enrollment

Study Arms (1)

Paired imaging

OTHER

Single arm, paired imaging of high resolution MRI (hrMRI) and stand MRI (sMRI)

Diagnostic Test: high resolution MRI (hrMRI)

Interventions

high resolution MRI (hrMRI) DIAGNOSTIC_TEST

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.

Paired imaging

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 years
• Patients diagnosed with clinically localized prostate cancer
• Low or Low-intermediate Risk Prostate cancer1 defined as:
• Pre-operative prostate specific antigen (PSA) ≤ 20.0 ng/ml
• Clinical stage cT1 or cT2
• Gleason score 3+3 or 3+4
• Patients choosing AS or already on AS as primary management strategy
• No previous treatment for prostate cancer with radiotherapy, chemotherapy, or hormonal therapy
• No contraindications for gadolinium enhanced MRI

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Limitations and Caveats

The number of patients in our study was relatively small. The reference standard was prostate biopsies, which is subject to sampling error. However, this was necessary when investigating a low-risk, small-volume cancer that is managed nonoperatively. Our study was performed at a single center and the imaging protocol was developed by our team.

Results Point of Contact

• Title: Dr. Hyung L Kim
• Organization: Cedars Sinai Medical Center

kimhl@cshs.org

310-423-4700

Study Officials

• Hyung L Kim, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single arm, paired imaging

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: September 26, 2017
• Study Start: September 13, 2017
• Primary Completion: December 14, 2022
• Study Completion: December 14, 2022
• Last Updated: April 3, 2024
• Results First Posted: April 3, 2024

Record last verified: 2024-03

Locations

US (1)