Integrated Genomic Prostate Score With MRI Targeted Prostate Biopsies

NCT04541030 | Active Not Recruiting

• 2 other identifiers: 99992013620-C-N136
• Study Type: observational
• Target: 241
• Locations: 1 country
• Sites: 2

Brief Summary

Background: Prostate cancer is one of the most common cancers in men. For some men, their cancer is monitored. Others have surgery to remove the prostate. Focal therapy is another treatment option. It treats the areas of cancer selectively, which leaves the rest of the prostate intact. This can help lessen side effects. Men who get focal therapy must be chosen carefully. The Oncotype DX Genomic Prostate Score (GPS) assay tests biopsy samples for certain cancer-related genes. It then then gives a score from 1 to 100 to predict the likelihood of poor outcomes. The GPS is used to choose men for focal therapy. Researchers want to test the GPS further. Objective: To assess how GPS may be useful when used with MRI to improve how men are chosen for focal therapy of prostate cancer. Eligibility: Men age 18 and older who had NCCN low or intermediate risk prostate cancer and had MRI and radical prostatectomy at the Urologic Oncology Branch, National Cancer Institute and collaborating centers. Design: This is a multisite study. It will review data and samples that were collected in the past. Samples and images from up to 277 participants will be used. Tumor tissue will be tested with the GPS. Data such as age at diagnosis, race, biopsy results, and pathology results will be merged with the GPS results. Data will be entered into an in-house electronic system. It will be password protected. All data will be kept in secure sites that comply with NIH security standards.

Conditions

Prostate Cancer

Keywords

Gleason Score; Multiparameter MRI; Focal Therapy; Natural History

Outcome Measures

Primary Outcomes (1)

• relationship between continuous GPS score and occult high-risk disease

  To determine if there is a positive relationship between continuous GPS score and occult high-risk disease on whole mount prostatectomy specimens where an MRI was performed less than 6 months before diagnostic biopsy, and the biopsy was less than 6 months before RP and the lesion was not identified on mpMRI

  2-3 years

Secondary Outcomes (1)

• distributions of clinical, pathological and demographic variables

  2-3 years

Study Arms (1)

GPS Cohort 1

Samples and images from up to 277 evaluable patients diagnosed with NCCN low or intermediate risk prostate cancer, Gleason \<= 7, managed with RP, and mpMRI within 6 months prior to prostatectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Samples from male patients with NCCN low or intermediate risk disease managed with radical prostatectomy (multiparametric MRI (mpMRI) performed within 6 months prior to the prostatectomy indicating localized, organ confined disease and adequate diagnostic biopsy tissue specimen).

You may qualify if:

• Samples and images from men \> =18 with NCCN very low, low, or intermediate risk prostate cancer with tumor tissue that meet the pathologic tissue requirements of the Oncotype DX Genomic Prostate Score assay
• Biopsy Gleason Score 7 or lower within 6 months preceding radical prostatectomy
• Tesla MRI with/without coil performed within 6 months preceding diagnostic biopsy
• Availability of diagnostic biopsy

You may not qualify if:

• Any active therapy received for prostate cancer (e.g., hormonal treatment, radiation, chemotherapy, biologic agents, surgery) prior to radical prostatectomy. 5 alpha reductase inhibitor treatment will not be considered to be hormonal treatment for this definition
• Men with NCCN high risk or very high-risk prostate cancer
• Biopsy Gleason 8
• No biopsy tissue available
• Missing surgical pathology whole mount, or unwilling to send surgical pathology whole mount to NCI for review
• Missing diagnostic PSA
• Missing clinical T stage
• Known lymph node positive or metastatic disease at time of diagnosis
• Missing MRI 6 months before diagnostic biopsy

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Peter A Pinto, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2020
• First Posted: September 9, 2020
• Study Start: September 2, 2020
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-03-19

Locations

US (2)