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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months after diagnostic prostate biopsy

Awards & highlights

MAGIC Trial 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.Check my eligibility

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.See study design

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.

MAGIC Trial 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.

MAGIC Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

The proportion of men with reclassification within 18 months

MAGIC 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 / 2Eligibility criteria met

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Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,586 Previous Clinical Trials

916,820 Total Patients Enrolled

19 Trials studying Prostate Cancer

2,737 Patients Enrolled for Prostate Cancer

United States Department of DefenseFED

864 Previous Clinical Trials

327,377 Total Patients Enrolled

38 Trials studying Prostate Cancer

8,982 Patients Enrolled for Prostate Cancer

Media Library

Genomic Prostate Score assay and Multi-parametric magnetic resonance imaging study of the prostate Clinical Trial Eligibility Overview. Trial Name: NCT05424783 — N/A

Prostate Cancer Research Study Groups: Genomic Prostate Score assay and multi-parametric MRI of the prostate

Prostate Cancer Clinical Trial 2023: Genomic Prostate Score assay and Multi-parametric magnetic resonance imaging study of the prostate Highlights & Side Effects. Trial Name: NCT05424783 — N/A

Genomic Prostate Score assay and Multi-parametric magnetic resonance imaging study of the prostate 2023 Treatment Timeline for Medical Study. Trial Name: NCT05424783 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being observed in this investigation?

"Affirmative. According to clinicaltrials.gov, this research initiative is actively recruiting patients; it was initially posted on October 15th 2022 and most recently modified on October 11th 2022. The trial requires 222 participants from 1 location in order to complete the study."

Answered by AI

Are there any vacancies in this research study that participants can apply for?

"Based on current information posted to clinicaltrials.gov, this research is actively seeking participants. This study was originally published on October 15th 2022 and the details were most recently updated 11 days later on October 11th."

Answered by AI

What type of individual is ideal for participation in this experiment?

"This medical trial seeks 222 male participants aged between 40 and 76 with prostate cancer classified as very low to favorable intermediate risk by the NCCN. Furthermore, they must have been diagnosed within 3 months of enrollment, and declare their willingness to consider active surveillance for treatment."

Answered by AI

Does the current protocol for this clinical trial accept participants under thirty years of age?

"The cut-off age for this trial is 76, so only patients from 40 to 76 years old can qualify. Comparatively, there are 1316 trials available for those over 65 and just 76 for minors under 18."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

MRI And GPS Informing Choices for Prostate Cancer Treatment (MAGIC)

Adam Murphy 2022. "MRI And GPS Informing Choices for Prostate Cancer Treatment (MAGIC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05424783.

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