NCT02425592Completed
Active Surveillance in Prostate Cancer, Imaging to Detect Radiographic Progression as an Endpoint (ASPIRE)
Source: ClinicalTrials.gov · Last updated 23 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 223 (actual)
- First submitted
- 16 Apr 2015
- Start date
- 1 Apr 2015
- Primary completion date
- 30 May 2022
- Lead sponsor
- Yale University
- Diseases
- Prostate cancer
- NCT number
- NCT02425592
What you commit to
- Study type: Observational
- Participants enrolled: 223
- From 1 Apr 2015 to the primary completion date, 30 May 2022
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received treatment for prostate cancer (hormone manipulation, surgery, radiation).
Other illness
- Known metastatic disease
- High risk prostate cancer by Epstein Criteria
- Any Gleason 7 or higher prostate cancer on prostate biopsy
Age
- Life expectancy \<10 years
Other
- Inability to receive an MRI with IV gadolinium contrast
- Unwillingness to undergo monitoring and imaging studies
- Non-English speaking
Who the study is looking for
- 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
Age in the registry: 30 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| VA Connecticut Healthcare System (VACT) Coordinator of this site? Confirm its status | West Haven | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.