Active Surveillance in Prostate Cancer, Imaging to Detect Radiographic Progression as an Endpoint (ASPIRE)
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 30 - 80 |
| Updated: | 1/11/2018 |
| Start Date: | April 2015 |
| End Date: | May 2020 |
| Contact: | Preston Sprenkle, MD |
| Email: | Preston.Sprenkle@yale.edu |
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.
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.
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.
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.
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
-
- 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
We found this trial at
2
sites
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