Clinical trial · Observational
Active Surveillance in Prostate Cancer, Imaging to Detect Radiographic Progression as an Endpoint (ASPIRE)
NCT02425592CI-TRIAL-00092531ASPIREcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Men on Active Surveillance
- description
- This study will include men between age 30-80 with Gleason 6 prostate cancer, prostate specific antigen (PSA) \<20, clinical stage \<cT3, and a life expectancy of at least ten years. To be eligible, men must have undergone an MRI-USG fusion prostate biopsy for an elevated PSA or abnormal prostate examination that demonstrates Gleason 6 prostate cancer. If a man is already on active surveillance, the MRI-USG fusion biopsy may be negative or confirm Gleason 6 prostate cancer. Eligible men will be approached at their post fusion-biopsy visit to discuss the biopsy results and offered enrollment in the trial.
Primary outcomes (2)
- measure
- Tumor Histologic Progression Rate
- timeFrame
- 3 years
- description
- MRI-US Fusion biopsy
- measure
- Tumor Radiologic Progression Rate
- timeFrame
- 3 years
- description
- MRI
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 30 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.