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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-02-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This pilot clinical trial studies transrectal magnetic resonance imaging (MRI)-guided biopsy to see how well it works in identifying cancer in patients with suspected prostate cancer who are scheduled to undergo standard biopsy. Transrectal MRI-guided biopsy uses a thin needle inserted through the rectum into the prostate and takes a sample of tissue, guided by MRI. MRI uses magnets to take pictures of the prostate and may be able to identify cancer. Transrectal MRI-guided biopsy may be more accurate and cause patients less pain than standard ultrasound-guided biopsy. It is not yet known whether transrectal MRI-guided biopsy is more effective than ultrasound-guided biopsy in identifying prostate cancer.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

MRI Guided Prostate Biopsy

NCT06302595

Suspected Prostate Cancer

RECRUITING NA

Phase I Study of Intensity Modulated Radiation Therapy for Prostate Cancer

NCT00124917

Prostate Cancer

TERMINATED PHASE1

Contrast Enhanced MRI of the Prostate

NCT02245282

Prostatic Neoplasms

COMPLETED

Multi-parametric Magnetic Resonance Imaging for Prostate Cancer Patients

NCT03180398

Prostate Cancer

TERMINATED NA

An Investigational Scan (18F-rhPSMA-7.3 PET-mpMRI) for Targeted Prostate Biopsy Using TRUS-MR Fusion Technique

NCT06865768

Prostate Carcinoma

RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PRIMARY OBJECTIVES:

I. To improve the treatment of patients with prostate cancer utilizing diagnostic multi-parametric magnetic resonance imaging (MRI) and MRI-guided prostate biopsy combined with molecular and clinical data to help determine the extent of prostate cancer and risk of disease progression.

II. To determine the relative accuracy of transrectal MRI-guided versus ultrasound-guided biopsy for the diagnosis of prostate cancer in patients with an appropriate dominant target lesion at multiparametric MRI, using pooled cancer diagnoses by either MRI-guided or ultrasound-guided biopsy as the reference standard.

III. To determine the proportion of positive transrectal MRI-guided biopsies that demonstrate a higher Gleason score than contemporaneous transrectal ultrasound guided biopsy.

IV. To determine the management impact of transrectal MRI-targeted biopsy results as compared to transrectal ultrasound (TRUS)-guided systematic biopsy results.

OUTLINE:

Patients receive gadodiamide intravenously (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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Health Status Unknown Prostate Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

3 Tesla Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast

Gadodiamide

Intervention Type RADIATION

Given IV

Multiparametric Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast

Transrectal Biopsy

Intervention Type PROCEDURE

Undergo transrectal MRI-guided biopsy

Ultrasound-Guided Prostate Biopsy

Intervention Type PROCEDURE

Undergo TRUS-guided biopsy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

3 Tesla Magnetic Resonance Imaging

Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast

Intervention Type PROCEDURE

Gadodiamide

Given IV

Intervention Type RADIATION

Multiparametric Magnetic Resonance Imaging

Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast

Intervention Type PROCEDURE

Transrectal Biopsy

Undergo transrectal MRI-guided biopsy

Intervention Type PROCEDURE

Ultrasound-Guided Prostate Biopsy

Undergo TRUS-guided biopsy

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

3 Tesla MRI 3T MRI DV 7572 Gadolinium-DTPA-BMA Gd-DTPA-BMA HSDB 7547 OmniScan Multiparametric MRI Transrectal Prostate Biopsy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Scheduled TRUS-guided biopsy because of clinically suspected prostate cancer (abnormal serum prostate-specific antigen \[PSA\] level and/or abnormal digital rectal examination)
* No treatment for prostate cancer has been administered or will be administered before TRUS guided biopsy
* Patient willing to undergo scheduled standard of care TRUS guided biopsy
* Patient willing and able to provide written informed consent, including willingness to undergo both endorectal multiparametric MRI and transrectal MRI-guided biopsy at Oregon Health \& Science University (OHSU)
* Laboratory values and anticoagulation management per consensus guidelines, including:
* International normalized ratio (INR) \>= 1.5
* Platelets \>= 50,000

Exclusion Criteria

* Known contraindication to MRI (e.g., severe claustrophobia, intracranial aneurysm clips, intraocular metallic foreign body, cardiac pacemaker); an extensive screening questionnaire will be completed by the subject as part of standard OHSU MRI safety measures
* Known contraindication to intravenous gadolinium contrast administration (e.g., renal impairment, known allergy); standard institutional policies on gadolinium and renal function will be followed
* Contraindication to placement of endorectal MRI coil, biopsy device or ultrasound probe (e.g., severe hemorrhoids, anal fissure, recent rectal surgery, or prior abdominoperineal resection)
* Previous inclusion in the study (e.g., a patient who has had negative TRUS and MRI-guided biopsies but continues to have a rising PSA)
* Active urinary tract infection
* Member of vulnerable population including prisoners or mentally disabled patients, in accordance with U.S. Department of Health and Human Services (DHHS) definitions

Eligible Sex

MALE

Accepts Healthy Volunteers

No