rhPSMA-73 PET-MRI Imaging for the Detection of Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance

Launched by NORTHWESTERN UNIVERSITY · May 1, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new imaging technique called rhPSMA-73 PET-MRI to see if it can better detect higher grade prostate cancer in men who are at low risk or have favorable intermediate risk prostate cancer. The goal is to determine if this advanced imaging can help doctors identify any changes in the cancer that might need closer attention or treatment, even in patients who are currently being monitored without immediate treatment (a strategy known as active surveillance).

To participate, men must be at least 18 years old, have a specific type of prostate cancer (Gleason Grade Group 1 or 2), and meet certain health criteria, such as being generally healthy with a good life expectancy. Participants will undergo a PET-MRI scan, which combines a special imaging test using a radioactive drug with detailed MRI scans of the prostate. They will also need to have a biopsy done within a few months before the scan. It's important to note that those who have had previous treatments for prostate cancer or certain medical conditions may not be eligible for this trial. This trial is currently looking for volunteers who want to contribute to research that could improve prostate cancer detection and treatment.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Healthy men (Eastern Cooperative Oncology Group \[ECOG\] 0-1), \>= 18 years old with at least 10 year life expectancy
• • Histologically proven Gleason Grade Group 1 or 2 adenocarcinoma of the prostate
• • Last prostate cancer containing biopsy performed within 3-15 months (mo.) prior to screening. Biopsy must have been \>= 10 core biopsy and informed by prior mpMRI
• • Prostate cancer categorized as low risk or favorable risk by National Comprehensive Cancer Network (NCCN) criteria (low risk is defined as T1c-T2a, prostate-specific antigen \[PSA\] \< 10ng/ml, Gleason Grade Group 1 \[Gleason 3+3=6\] disease) and favorable intermediate risk as having no more than one of the following intermediate risk features, clinical T2b-T2c disease, PSA 10-20ng/ml, Gleason Grade Group 2 \[Gleason score 3+4=7\])
• • Decipher genomic classifier score from prior biopsy \>= 0.45
• • Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written informed consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures
• • Concurrent diseases and malignancies are permitted
• • Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on the study
• • Willing to undergo prostate biopsy prior to non-surgical treatment of prostate cancer and within 90 days of PET-MRI imaging
• Exclusion Criteria:
• • Prior radiotherapy, surgery, chemotherapy, or hormonal therapy for prostate cancer
• • NCCN very low risk category (T1c and Gleason Grade Group 1 \[Gleason score 3+3=6\], PSA \< 10 ng/mL, fewer than 3 prostate biopsy cores positive, =\< 50% cancer in any core, PSA density \< 0.15 ng/mL/g)
• • Decipher score \< 0.45
• • Prior bladder outlet procedure (i.e,. holmium laser enucleation of the prostate \[HoLEP\], transurethral resection of the prostate \[TURP\], Urolift, Rezum)
• • Prohibited medications: use of 5 alpha reductase inhibitor or androgen deprivation therapy (i.e., leuprolide, relugolix) within 1 month of screening
• • Contra-indication or relative contra-indication to MRI (i.e., pacemaker)
• • History of hip replacement
• • Subject has received investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening