Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT03234556
Brief Summary:
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.
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.
Study:
NCT03234556
Study Brief:
Protocol Section:
NCT03234556