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Completed

NCT Number: NCT01764347

Magnetic Resonance Imaging-Transrectal Ultrasound Fusion Image-Guided Prostate Biopsy Following Radical Prostatectomy in Patients With Prostate Cancer

This pilot clinical trial studies magnetic resonance imaging (MRI)-transrectal ultrasound (TRUS) fusion image-guided prostate biopsy following radical prostatectomy in patients with prostate cancer. Diagnostic procedures, such as MRI-TRUS fusion image-guided prostate biopsy may help find and diagnose prostate cancer

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

About this study

PRIMARY OBJECTIVES:

I. To evaluate accuracy of the new image-guided targeted needle biopsy using the ex-vivo human prostate as obtained from fresh radical prostatectomy specimens.

OUTLINE: Patients undergo robotic radical prostatectomy, followed by 3 MRI-TRUS fusion image-guided prostate biopsies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects must have biopsy-proven prostate cancer, or prostate-specific antigen (PSA) >= 4 ng/ml or an abnormal digital rectal examination (DRE) if consented before prostate biopsy
  • Subjects must have at least 2, preferably 3, pre-operative magnetic resonance imaging (MRI)-identified malignant or benign lesions that measure between 10 mm and 15 mm in diameter within the prostate
  • Subjects must have decided to have their prostate surgically removed

Exclusion criteria

  • Patients who do not give informed consent
  • Patients with extracapsular extension of their prostate cancer

Treatment and study plan

therapeutic conventional surgery

Procedure

Undergo robotic radical prostatectomy

Ultrasound-Guided Prostate Biopsy

Procedure

Undergo MRI-TRUS fusion image-guided prostate biopsy

Magnetic Resonance Imaging

Procedure

Undergo MRI-TRUS fusion image-guided prostate biopsy

Other names: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging

Primary outcomes

  1. Number of times the first biopsy needle is placed within 3.0 mm of the center lesion

    Time frame: One month after last patient enrolled is taken off study

    A likelihood ratio test will be used to test for independence among lesions within a prostate (corresponding to a lack of systematic MRI-TRUS image distortion and implying that, overall, 1st biopsies to a lesion within one prostate are as likely to accurate as in another prostate).

  2. Number of times the second biopsy needle is placed within 3.0 mm of the center lesion

    Time frame: One month after last patient enrolled is take off study

    A likelihood ratio test will be used to test for independence among lesions within a prostate (corresponding to a lack of systematic MRI-TRUS image distortion and implying that, overall, 1st biopsies to a lesion within one prostate are as likely to accurate as in another prostate).

Secondary outcomes

  1. Average distance of the first needle to the center of the lesion

    Time frame: One month after last patient enrolled is taken off study

    A nested (random effects) analysis of variance (ANOVA) will be used to analyze the distance of the first needle from the center of the lesion. Standard error or 95% confidence interval will be calculated.

  2. Average distance of the second needle from the first needle minus 2.0 mm

    Time frame: One month after last patient enrolled is taken off study

    A nested (random effects) ANOVA will be used to analyze the distance of the first needle from the center of the lesion.

  3. Average distance of the third needle from the first needle minus 2.0 mm

    Time frame: One month after last patient enrolled is taken off study

    A nested (random effects) ANOVA will be used to analyze the distance of the first needle from the center of the lesion.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Accuracy of Targeted Biopsies Using MRI-TRUS Fusion Guidance: Pilot Study on Ex Vivo Radical Prostatectomy Specimens

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Jan 9, 2013
Registry last updated
Jan 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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