Purpose

This randomized phase II trial studies how well systematic random biopsy or magnetic resonance imaging (MRI)-ultrasound image (US) fusion biopsy work in diagnosing prostate cancer in patients with elevated prostate specific antigen. Systematic random biopsy and MRI-US fusion biopsy may work better in improving the accuracy of prostate cancer detection.

Conditions

Eligibility

Eligible Ages
Over 40 Years
Eligible Genders
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
  • Note: HIPAA authorization may be included in the informed consent or obtained separately
  • Eastern Cooperative Oncology Group (ECOG) performance status of =< 1 within 3 months (93 days) prior to being registered for protocol
  • African-American or white men (Hispanic or non-Hispanic)
  • Prostate biopsy-naive or a single negative biopsy
  • Having elevated prostate specific antigen (PSA) (> 2.5 ng/ml) and no palpable nodule on digital rectal exam (DRE)
  • Ability to understand the willingness to sign a written informed consent
  • Patients must be willing to undergo a radiologic imaging before and after biopsy of the prostate
  • Patients must be willing to undergo a biopsy of the prostate

Exclusion Criteria

  • Patients who have had chemotherapy or radiotherapy within 12 months of the study for other diagnoses not related to prostate cancer
  • Patients receiving any other investigational agents
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients with active inflammatory bowel disease
  • Patients who are unable to undergo MRI
  • Patients who had any surgery of the prostate including TURP (transurethral resection of the prostate)
  • Patients who had > 1 prior prostate biopsy

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Arm I (SR-Bx)
Patients undergo SR-Bx. If SR-Bx doesn't reveal clinically significant cancer, then MRI will be done in 3 months, and if lesion is present (PIRADS ≥ 3) schedule for MRUS-Bx. If there is no lesion, then no biopsy. Schedule MRI in 12 months after the initial MRI.
  • Procedure: Biopsy of Prostate
    Undergo SR-Bx
    Other names:
    • Prostate Biopsy
    • Prostatic Biopsy
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Diagnostic Test: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MRI
    • MRI Scan
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
  • Diagnostic Test: MRI Ultrasound Fusion Guided Biopsy
    Undergo MRUS-Bx
    Other names:
    • Fusion Biopsy
    • Fusion-Guided Biopsy
    • MR Fusion Biopsy
    • MRI-Ultrasound Fusion Biopsy
    • MRI/Ultrasound Fusion Biopsy
    • MRI/US Biopsy
Experimental
Arm II (MRI, MRUS-Bx, SR-Bx)
Patients undergo MRI. Must be scheduled at least one day before MRUS biopsy. If MRI shows no lesion present (PIRADS 1-2), then no MRUS-Bx. Schedule for SR-Bx only. If MRI shows lesion present (PIRADS ≥ 3), perform MRUS-Bx, which will be done first and followed immediately by SR-Bx.
  • Procedure: Biopsy of Prostate
    Undergo SR-Bx
    Other names:
    • Prostate Biopsy
    • Prostatic Biopsy
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Diagnostic Test: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MRI
    • MRI Scan
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
  • Diagnostic Test: MRI Ultrasound Fusion Guided Biopsy
    Undergo MRUS-Bx
    Other names:
    • Fusion Biopsy
    • Fusion-Guided Biopsy
    • MR Fusion Biopsy
    • MRI-Ultrasound Fusion Biopsy
    • MRI/Ultrasound Fusion Biopsy
    • MRI/US Biopsy

Recruiting Locations

University of Maryland
Baltimore, Maryland 21201
Contact:
Ganine Markowitz-Chrystal
410-328-0800
gmarkowitz@som.umaryland.edu

More Details

NCT ID
NCT03234556
Status
Recruiting
Sponsor
University of Southern California

Study Contact

Ileana Aldana
323-865-0702
Ileana.aldana@med.usc.edu

Detailed Description

PRIMARY OBJECTIVES:

I. To compare the detection of clinically significant prostate cancer (CSPCa) in Arm 1 versus Arm 2.

II. To compare between African American (AA) and white men the probability of developing CSPCa within three years of initial biopsy at the start of the study.

SECONDARY OBJECTIVES:

I. To determine complications and patient morbidity associated with either systematic random prostate biopsy (SR-Bx) versus (vs) magnetic resonance imaging-ultrasound image fusion biopsy (MRUS-Bx) + SR-Bx.

TERTIARY OBJECTIVES:

I. To compare Gleason score between MRUS-Bx and radical prostatectomy (RP) specimen among men who elect RP (~110 in the randomized controlled trial [RCT]).

II. To assess within Arm 1 the detection of CSPCa three months after SR-Bx among men initially diagnosed with clinically insignificant prostate cancer (CinsPCa) or no cancer.

III. To identify among men invited to participate and those actually enrolled in the RCT: determinants of study participation.

IV. To identify among men invited to participate and those actually enrolled in the RCT: determinants of treatment decision (active surveillance [AS] vs radiation vs RP) including the diagnostic method.

OUTLINE: Patients are randomized into 1 of 2 arms.

ARM I: SR-Bx group

- Patients undergo SR-Bx

- If SR-Bx doesn't reveal clinically significant cancer, then MRI in 3 months, and if lesion is present (PIRADS ≥ 3) schedule for MRUS-Bx.

- If there is no lesion, then no biopsy - schedule MRI in 12 months after the initial MRI.

ARM II: MRUS-Bx group

- Patients undergo MRI. Must be scheduled at least 1 day before MRUS Biopsy.

- MRI shows no lesion present (PIRADS 1-2): no MRUS-Bx, schedule for SR-Bx only.

- MRI lesion present (PIRADS ≥ 3): schedule for MRUS-Bx, which will be done first and followed immediately after by SR-Bx.

FOLLOW UP:

After completion of procedure, patients are followed up at 2-4 weeks, 3, 6, 9, and 12 months, and then periodically for up to 5 years.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.