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

January 4, 2024 updated by: Yale University

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University
      • West Haven, Connecticut, United States, 06516
        • VA Connecticut Healthcare System (VACT)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor Histologic Progression Rate
Time Frame: 3 years
MRI-US Fusion biopsy
3 years
Tumor Radiologic Progression Rate
Time Frame: 3 years
MRI
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety Using Cancer Distress Thermometer Scores
Time Frame: 3 years
serial anxiety measurements on standardized scale
3 years
Urinary Function Using International Prostate Symptom Scores
Time Frame: 3 years
monitoring urinary symptoms using standardized questionnaire
3 years
Erectile Function Using Sexual Health Inventory for Men Scores
Time Frame: 3 years
monitoring sexual function as measured by standardized questionnaire
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Preston Sprenkle, MD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

May 30, 2022

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

April 16, 2015

First Submitted That Met QC Criteria

April 20, 2015

First Posted (Estimated)

April 24, 2015

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1501015246

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe