Using advanced imaging to detect prostate cancer in men eligible for active surveillance

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of rhPSMA-7.3 PET-MRI imaging in identifying higher grade prostate cancer in men with low and favorable intermediate risk who are candidates for active surveillance. Participants will receive the radioactive drug rhPSMA-7.3 intravenously, followed by PET-MRI and multiparametric MRI scans of the prostate. The study aims to measure the detection rate of clinically significant disease and assess the safety of the imaging approach. Additionally, it will explore the correlation between imaging findings and genomic classifiers related to prostate cancer.

Why it matters

Who can join: the full rules

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

Where it's running

• Northwestern University
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Ashley E Ross — Northwestern University
• Study coordinator: Sophia Kallas
• Email: sophia.kallas@northwestern.edu
• Phone: 312-694-9001

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.