Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patients with an elevated PSA (PSA ≤ 10 ng/ml) and/or abnormal prostate findings.
- Patients who are biopsy-naïve or have received a prior negative biopsy or a prior biopsy positive for lower grade cancer on active surveillance.
Exclusion Criteria:
- Unable or unwilling to provide informed consent.
- Vulnerable study populations.
- PSA ≥ 10 ng/mL.
- Metastatic prostate cancer – defined as pathologic N+ on final pathology or radiographic evidence of metastatic disease on preprocedural testing.
- No active (nonskin) malignancy within the past 2 years excluding low risk prostate cancer.
- Current treatment with any form of hormone, antiandrogen, or androgen deprivation therapy.
- Treated with any form of chemotherapy or pelvic radiotherapy within the past 5 years.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 2/21/2025. Questions regarding updates should be directed to the study team contact.