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GPS Assay + MRI for Prostate Cancer (MAGIC Trial)

N/A

Recruiting

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have NCCN very low to favorable intermediate risk prostate cancer

Participants must be male, age 40-76 years old

Must not have

Participants with no access to the rectum for a transrectal ultrasound

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months after diagnostic prostate biopsy

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying whether the GPS assay and MRI can help risk stratify men on active surveillance to identify those likely to harbor undetected aggressive disease in their prostate, which may improve safety and patient adherence with monitoring.

Who is the study for?

The MAGIC trial is for men aged 40-76 with very low to favorable intermediate risk prostate cancer, diagnosed within the last 3 months and considering active surveillance. It excludes those who can't have an MRI or transrectal ultrasound, can't complete surveys, or have less than a decade expected lifespan.

What is being tested?

This study tests if using Genomic Prostate Score (GPS) assays and multi-parametric MRIs helps better identify aggressive prostate tumors in men opting for active surveillance. The goal is to see if these tools improve patient adherence to monitoring protocols over 18 months.

What are the potential side effects?

Potential side effects are not explicitly mentioned but may include anxiety from false positive results leading to unnecessary treatments. Regular monitoring such as biopsies could also carry risks like infection or discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer is classified from very low to favorable intermediate risk.

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I am a man aged between 40 and 76.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot have a transrectal ultrasound due to lack of rectal access.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months after diagnostic prostate biopsy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months after diagnostic prostate biopsy

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months after diagnostic prostate biopsy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of men who had an active surveillance prostate biopsy by 18 months

Secondary study objectives

The proportion of men with reclassification within 18 months

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Genomic Prostate Score assay and multi-parametric MRI of the prostateExperimental Treatment1 Intervention

Men with newly diagnosed NCCN very low to favorable intermediate risk prostate cancer will be enrolled at their post biopsy urologist visit. Once enrolled, participants will have their prostate tissue sent off for their Genomic Prostate Score assay and men will undergo a prostate MRI to evaluate for potentially missed clinically significant prostate cancer. In a subsequent urologist visit, participants will choose their treatment choice. Men who choose active surveillance for their primary treatment choice will be monitored per clinical routine by PSA, digital rectal exam, and active surveillance prostate biopsy in 12-18 months. After month 6, men will be followed through their electronic medical records system to track adherence to their 12-18 month active surveillance prostate biopsy.

0 / 3Eligibility criteria met