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

Sponsor
Yale University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02425592
Collaborator
(none)
200
Enrollment
2
Locations
121
Anticipated Duration (Months)
100
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    MRI Fusion prostate biopsy will transform Active Surveillance (AS) for men with low risk prostate cancer. Treatment for prostate cancer, usually surgical removal or radiation delivered to the whole prostate, is associated with significant morbidity including incontinence and impotence.

    The goal of this and future research is to maximize the effectiveness of prostate imaging in order to minimize the morbidity of prostate biopsy and hence improve the quality of life of patients with prostate cancer. There are many applications to improved imaging of prostate cancer, but several the investigators are interested in include: improved risk stratification to limit unnecessary treatment while providing appropriate treatment to prevent progression; limiting the number of biopsies needed for diagnosis and/or decreasing the frequency of biopsies and hence decreasing biopsy-related morbidity; focal therapy for confirmed focal disease rather than treating the entire prostate in order to limit the significant morbidity associated with whole-gland treatment.

    This is an investigator-initiated, multi-center, prospective observational phase II trial evaluating MRI to detect prostate cancer progression in patients with low risk prostate cancer on Active Surveillance. The two centers involved will be the Yale-New Haven Hospital Smilow Cancer Center (Yale) and the VA Connecticut Healthcare System (VACT). The Yale School of Medicine will serve as the central data-coordinating center for this study.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Active Surveillance in Prostate Cancer, Imaging to Detect Radiographic Progression as an Endpoint (ASPIRE)
    Actual Study Start Date :
    Apr 1, 2015
    Actual Primary Completion Date :
    May 30, 2022
    Anticipated Study Completion Date :
    May 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Tumor Histologic Progression Rate [3 years]

      MRI-US Fusion biopsy

    2. Tumor Radiologic Progression Rate [3 years]

      MRI

    Secondary Outcome Measures

    1. Anxiety Using Cancer Distress Thermometer Scores [3 years]

    2. Urinary Function Using International Prostate Symptom Scores [3 years]

    3. Erectile Function Using Sexual Health Inventory for Men Scores [3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 80 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yale University New Haven Connecticut United States 06520
    2 VA Connecticut Healthcare System (VACT) West Haven Connecticut United States 06516

    Sponsors and Collaborators

    • Yale University

    Investigators

    • Principal Investigator: Preston Sprenkle, MD, Yale University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yale University
    ClinicalTrials.gov Identifier:
    NCT02425592
    Other Study ID Numbers:
    • 1501015246
    First Posted:
    Apr 24, 2015
    Last Update Posted:
    Jun 14, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Jun 14, 2022