GPS Assay + MRI for Prostate Cancer

(MAGIC Trial)

Recruiting at 1 trial location

Overseen By Daniel Moreira

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Life expectancy <10 years, MRI contraindication, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

222 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the Genomic Prostate Score (GPS) assay and a special prostate MRI can assist men with low to intermediate risk prostate cancer in making informed treatment decisions. The researchers aim to determine if these tests can identify aggressive cancer early, promote regular check-ups, and reduce unnecessary treatments. The study will also track which tests help patients adhere to their monitoring schedule and predict cancer progression. Men diagnosed with low to intermediate risk prostate cancer who are open to active surveillance may be suitable candidates for this trial. As a Phase 2 trial, the study measures the effectiveness of these tests in an initial, smaller group, offering participants a chance to contribute to research that could enhance future cancer care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the GPS assay and multi-parametric MRI are safe for prostate cancer monitoring?

Research shows that the Genomic Prostate Score (GPS) test helps predict the potential severity of prostate cancer. It identifies men who may require more intense treatment or closer monitoring, allowing doctors to tailor care to each individual.

Regarding safety, the GPS test uses prostate tissue samples, avoiding the need for medication or risky procedures. There are no reports of physical side effects from the test itself.

Research has shown that the multi-parametric MRI of the prostate reliably finds and assesses prostate cancer. It is generally well-tolerated, similar to other MRI scans, with no significant reports of negative effects. However, some individuals might find it uncomfortable due to the noise and the need to remain still for an extended period.

Overall, both the GPS test and the multi-parametric MRI are considered safe and well-tolerated. They provide valuable information that aids doctors in making informed decisions about prostate cancer treatment and monitoring. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about combining the Genomic Prostate Score (GPS) assay with multi-parametric MRI for prostate cancer because it offers a more personalized and precise approach to diagnosis and treatment decisions. Unlike traditional methods that rely mainly on PSA levels and biopsy results, the GPS assay analyzes the genetic profile of prostate cancer cells, providing deeper insights into the aggressiveness of the cancer. Meanwhile, multi-parametric MRI helps to identify areas of the prostate that might be harboring clinically significant cancer that could be missed by standard biopsies. Together, these tools could improve the accuracy of prostate cancer assessments and help tailor treatment plans more effectively, potentially reducing the need for invasive procedures.

What evidence suggests that the GPS assay and MRI are effective for prostate cancer management?

In this trial, participants will undergo both the Genomic Prostate Score (GPS) test and multi-parametric MRI to evaluate prostate cancer. Studies have shown that the GPS test can predict outcomes for men with prostate cancer by analyzing 17 specific genes, aiding doctors and patients in choosing the best treatment plan. Research suggests that the GPS test is particularly beneficial for decisions about active surveillance, especially for men with intermediate-risk prostate cancer.

Research also shows that multi-parametric MRI helps in understanding prostate cancer. This type of MRI locates the cancer, assesses its risk, and aids in treatment planning. It can identify potentially aggressive tumors, assisting in the decision to monitor or treat the cancer. Together, GPS and MRI, as used in this trial, may enhance prostate cancer monitoring, possibly leading to better patient outcomes. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am open to monitoring my condition without immediate treatment.

Participants must be diagnosed within 3 months prior to study enrollment

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

Exclusion Criteria

Participants with a contraindication to magnetic resonance imaging (MRI)

Participants unable to complete standardized surveys

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment

Participants undergo Genomic Prostate Score assay and multi-parametric MRI of the prostate to provide personalized risk data

4 weeks

1 visit (in-person)

Active Surveillance Monitoring

Participants who choose active surveillance are monitored with PSA tests, digital rectal exams, and prostate biopsies

18 months

Regular visits as per clinical routine

Follow-up

Participants are monitored for safety and effectiveness after the active surveillance period

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Genomic Prostate Score assay
• Multi-parametric magnetic resonance imaging study of the prostate

Trial Overview 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.

How Is the Trial Designed?

Group I: Genomic Prostate Score assay and multi-parametric MRI of the prostate Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

In a study of 176 patients with suspicious findings on prostate mpMRI, the Prostate Imaging Reporting and Data System version 2 (PI-RADS v2) showed a positive predictive value (PPV) of 70.2% for detecting high-grade prostate cancer (Gleason score ≥7) in category 5 lesions, indicating its effectiveness in identifying serious cases.

The PPV was even higher at 88% for category 5 lesions located in the peripheral zone, demonstrating that both the PI-RADS category and the lesion's location significantly influence the likelihood of detecting clinically significant prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate zonal anatomy correlates with the detection of prostate cancer on multiparametric magnetic resonance imaging/ultrasound fusion-targeted biopsy in patients with a solitary PI-RADS v2-scored lesion. Syed, JS., Nguyen, KA., Nawaf, CB., et al.[2018]

In a study of 262 patients, specific magnetic resonance imaging features, particularly signal abnormalities and volume measurements, were effective in diagnosing clinically significant prostate cancers (csPCa), with the best models achieving an area under the curve (AUC) of up to 0.840.

The diagnostic performance improved when combining signal-related variables with factors like extracapsular extension and PSA density, indicating that a tailored approach based on the definition of csPCa can enhance diagnostic accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic value and relative weight of sequence-specific magnetic resonance features in characterizing clinically significant prostate cancers. Rouvière, O., Dagonneau, T., Cros, F., et al.[2018]

The 17-gene Oncotype DX® Genomic Prostate Score™ assay is a significant independent predictor of adverse pathology findings in men with very low, low, or intermediate risk prostate cancer, even when diagnosed through advanced imaging techniques like multiparametric MRI.

In a study of 134 men, the prostate score assay remained a strong predictor of adverse pathology after adjusting for other clinical factors, suggesting it can enhance risk stratification and treatment decisions for prostate cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 17-Gene Genomic Prostate Score Assay Provides Independent Information on Adverse Pathology in the Setting of Combined Multiparametric Magnetic Resonance Imaging Fusion Targeted and Systematic Prostate Biopsy. Salmasi, A., Said, J., Shindel, AW., et al.[2019]

The 17-gene Oncotype DX Genomic Prostate Score (GPS) test was evaluated in a study of 432 men with low-risk prostate cancer under active surveillance, but it did not significantly improve the prediction of adverse pathology (AP) compared to traditional clinical variables like Gleason Grade Group (GG) and prostate-specific antigen density (PSAD).

While GPS was associated with AP when adjusted for GG, this association became non-significant when PSAD was also considered, indicating that GPS may not provide additional predictive value in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

17-Gene Genomic Prostate Score Test Results in the Canary Prostate Active Surveillance Study (PASS) Cohort. Lin, DW., Zheng, Y., McKenney, JK., et al.[2022]

In a study of 100 men with low and intermediate risk prostate cancer, there was a significant association between the Genomic Prostate Score (GPS) and multi-parametric MRI (mpMRI) findings, indicating that both tests provide valuable but different insights into cancer characteristics.

While GPS results varied significantly across different mpMRI categories, a wide range of GPS values was observed within each category, suggesting that mpMRI and genomic profiling may complement each other rather than replace one another in clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between a 17-gene genomic prostate score and multi-parametric prostate MRI in men with low and intermediate risk prostate cancer (PCa). Leapman, MS., Westphalen, AC., Ameli, N., et al.[2018]

The Genomic Prostate Score (GPS) assay is a strong independent predictor of biochemical recurrence (BCR), distant metastases (DM), and prostate-specific death (PCD) in patients with unfavorable intermediate risk prostate cancer, based on an analysis of 299 patients from two studies.

Patients with a GPS score greater than 40 have outcomes indicative of high-risk disease, suggesting they may require more aggressive treatment options, while those with a score of 40 or lower have outcomes similar to favorable intermediate risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The 17-Gene Genomic Prostate Score Test as a Predictor of Outcomes in Men with Unfavorable Intermediate Risk Prostate Cancer. Cullen, J., Kuo, HC., Shan, J., et al.[2022]

In a study of 215 men on active surveillance for prostate cancer, a higher Oncotype Dx® Genomic Prostate Score (GPS) was linked to an increased risk of adverse pathology findings after radical prostatectomy, indicating its potential as a predictive tool for disease progression.

The GPS was also associated with a higher risk of biochemical recurrence post-surgery, suggesting that it may help identify patients who need closer monitoring or more aggressive treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 17-Gene Genomic Prostate Score as a Predictor of Adverse Pathology in Men on Active Surveillance. Kornberg, Z., Cooperberg, MR., Cowan, JE., et al.[2020]

In a study of 131 patients, the Prostate Imaging Reporting and Data System version 2 (PI-RADS v2) demonstrated moderate interobserver agreement among radiologists, with intraclass correlation coefficients (ICC) ranging from 0.67 to 0.74 for different lesion types.

Despite the moderate agreement, PI-RADS v2 effectively predicted the likelihood of intermediate- and high-grade prostate cancers, with positive predictive values (PPV) increasing significantly from 0% for category 2 to 87% for category 5, indicating its utility in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of Prostate Imaging Reporting and Data System Version 2 (PI-RADS v2): Interobserver Agreement and Positive Predictive Value for Localization of Intermediate- and High-Grade Prostate Cancers on Multiparametric Magnetic Resonance Imaging. Chen, F., Cen, S., Palmer, S.[2018]

In a study of 79 patients who underwent MRI-guided biopsy and radical prostatectomy, specific MRI features such as a PI-RADS score of 5 and suspicion of extraprostatic extension were significantly associated with shorter recurrence-free survival (RFS) after surgery.

Preoperative p53 immunohistochemistry stain intensity also correlated with RFS, suggesting that both imaging characteristics and molecular markers can help predict the risk of biochemical recurrence in prostate cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic Features of Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy Based on Multiparametric MRI and Immunohistochemistry Analysis of MRI-guided Biopsy Specimens. Harmon, SA., Gesztes, W., Young, D., et al.[2022]

Citations

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Genomic prostate score and treatment selection in ... The 17‐gene genomic prostate score test as a predictor of outcomes in men with unfavorable intermediate‐risk prostate cancer. Urology. 2020 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40104777/

Genomic prostate score and treatment selection in ... The GPS result and percent positive cores appear associated with AS use after controlling for relevant clinical variables in NCCN FIR prostate cancer patients.

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2021.39.6_suppl.218

Treatment decisions and outcomes for NCCN favorable ... This study determined how the 17-gene Genomic Prostate Score (GPS) assay guides treatment decisions in patients with NCCN favorable intermediate-risk prostate ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0360301622007180

The 17-Gene Genomic Prostate Score Test Is Prognostic ... The Oncotype DX Genomic Prostate Score (GPS) is a 17-gene assay that evaluates the expression of 12 cancer-related genes and 5 reference genes ...

5. ovid.com ovid.com/journals/jurol/pdf/10.1097/ju.0000000000000170~the-clinical-utility-of-the-genomic-prostate-score-in-men

The Clinical Utility of the Genomic Prostate Score in Men ... Purpose: We retrospectively investigated the Genomic Prostate Score® assay in clinical practice at an urban tertiary care academic center.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10587942/

Impact of genomic testing on urologists' treatment ... The Oncotype Dx Genomic Prostate Score (GPS) is a 17‐gene relative expression assay that predicts adverse pathology at prostatectomy.

7. consultqd.clevelandclinic.org consultqd.clevelandclinic.org/genomic-testing-can-predict-long-term-outcomes-in-prostate-cancer-patients-study-finds

Genomic Testing Can Predict Long-Term Outcomes in ... Findings from a 20-year study suggest that genomic testing can predict long-term outcomes of prostate cancer.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7213589/

17-Gene Genomic Prostate Score Test Results in the Canary ... The 17-gene Oncotype DX Genomic Prostate Score (GPS) test predicts adverse pathology (AP) in patients with low-risk prostate cancer treated with immediate ...

9. ecancer.org ecancer.org/en/news/25931-study-shows-how-genomic-tests-could-help-treat-prostate-cancer-more-effectively

Study shows how genomic tests could help treat prostate ... This review highlights that genomic tests can improve how doctors assess prostate cancer risk, but they don't always lead to major changes in treatment ...

10. cms.gov cms.gov/medicare-coverage-database/view/article.aspx?articleId=54613

Genomic Health™ Oncotype DX® Prostate Cancer Assay Response: The data capture consists of requisite patient information on the test requisition and biennial (2x/yr) submission of prostate cancer-related ...