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

NCT02425592 | Completed

• 1 other identifier: 1501015246
• Study Type: observational
• Target: 223
• Locations: 1 country
• Sites: 2

Brief Summary

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

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Tumor Histologic Progression Rate

  MRI-US Fusion biopsy

  3 years

• Tumor Radiologic Progression Rate

  MRI

  3 years

Secondary Outcomes (3)

• Anxiety Using Cancer Distress Thermometer Scores

  3 years

• Urinary Function Using International Prostate Symptom Scores

  3 years

• Erectile Function Using Sexual Health Inventory for Men Scores

  3 years

Study Arms (1)

Men on Active Surveillance

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.

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will include men between age 30-80 with Gleason 6 prostate cancer, PSA \<20, \<cT3, and a life expectancy of at least ten years.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (2)

Yale University

New Haven, Connecticut, 06520, United States

Location

VA Connecticut Healthcare System (VACT)

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Preston Sprenkle, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2015
• First Posted: April 24, 2015
• Study Start: April 1, 2015
• Primary Completion: May 30, 2022
• Study Completion: May 1, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)