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

Prostate Cancer Clinical Trial

— ASPIRE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02425592
• Other study ID #: 1501015246
• Status: Active, not recruiting
• Start date: April 2015
• Est. completion date: May 2025

Study information

• Verified date: January 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: May 2025
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut
United States	VA Connecticut Healthcare System (VACT)	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor Histologic Progression Rate	MRI-US Fusion biopsy	3 years
Primary	Tumor Radiologic Progression Rate	MRI	3 years
Secondary	Anxiety Using Cancer Distress Thermometer Scores	serial anxiety measurements on standardized scale	3 years
Secondary	Urinary Function Using International Prostate Symptom Scores	monitoring urinary symptoms using standardized questionnaire	3 years
Secondary	Erectile Function Using Sexual Health Inventory for Men Scores	monitoring sexual function as measured by standardized questionnaire	3 years