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Phase II

Active Surveillance in Prostate Cancer, Imaging to Detect Radiographic Progression as an Endpoint (ASPIRE)

  • Study HIC#:1501015246
  • Last Updated:07/15/2021

The objective in this study is to determine if MRI-identified progression can decrease frequency or need for repeated prostate biopsy in men on active surveillance (AS).

Our hypothesis is that MRI alone is adequate to detect progression of prostate cancer in men on active surveillance (AS) after a MRI-US fusion prostate biopsy.

  • Age30 years - 80 years
  • GenderBoth
  • Start Date06/10/2015
  • End Date05/30/2020

Trial Purpose and Description

The objective in this study is to determine if MRI-identified progression can decrease frequency or need for repeated prostate biopsy in men on active surveillance (AS).

Our hypothesis is that MRI alone is adequate to detect progression of prostate cancer in men on active surveillance (AS) after a MRI-US fusion prostate biopsy.

Eligibility Criteria

Inclusion Criteria:

  • Age 30-80
  • Completed MRI Fusion prostate biopsy either in the past that demonstrated Gleason 6 prostate cancer and are either currently enrolled in Active Surveillance or are interested in Active surveillance, or have completed an MRI Fusion prostate biopsy at the first visit that demonstrates Gleason 6 prostate cancer and are interested in Active Surveillance
  • Diagnosed with Gleason 6 prostate cancer
  • PSA <20
  • <cT3 prostate cancer
  • Ability to receive an MRI with IV gadolinium contrast
  • Life expectancy >10 years (by physician estimate)
  • Understanding and willingness to provide consent
  • English speaking

Exclusion Criteria:

  • Received treatment for prostate cancer (hormone manipulation, surgery, radiation).
  • Known metastatic disease
  • High risk prostate cancer by Epstein Criteria
  • Any Gleason 7 or higher prostate cancer on prostate biopsy
  • Inability to receive an MRI with IV gadolinium contrast
  • Life expectancy <10 years
  • Unwillingness to undergo monitoring and imaging studies
  • Non-English speaking

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