Implantable Microdevice for the Evaluation of Drug Response in Patients with Prostate Cancer

Inclusion Criteria

• EX VIVO COHORT: Patients must have the ability to understand and the willingness to sign a written informed consent document at the study site when both the investigator and participant are at the same location, or remotely (e.g., at the participant’s home or another convenient venue) where the participant reviews the consent document with the licensed physician investigator over secure Zoom. The electronic consent system, Adobe eSign, ensures the participant electronically signing the informed consent is the subject who will be participating in the research study
• EX VIVO COHORT: Planned radical prostatectomy for prostate cancer
• EX VIVO COHORT: Participants must be 22 years of age or older
• SURGICAL COHORT: Patients must have the ability to understand and the willingness to sign a written informed consent document at the study site when both the investigator and participant are at the same location, or remotely (e.g., at the participant’s home or another convenient venue) where the participant reviews the consent document with the licensed physician investigator over secure Zoom. The electronic consent system, Adobe eSign, ensures the participant electronically signing the informed consent is the subject who will be participating in the research study
• SURGICAL COHORT: Participants must present with prostate cancer falling into an intermediate or high risk category to include features: Gleason score 3+4 or higher, greater than 3 biopsy cores positive and >= 50% of 1 core positive for carcinoma, and a magnetic resonance imaging (MRI)-visible lesion concerning for prostate cancer (PCa) in the region of the positive biopsy
• SURGICAL COHORT: Participants must be 22 years of age or older
• SURGICAL COHORT: Participants must be evaluated by a urologic oncologist who will determine the clinically appropriate treatment strategy based on clinical history and extent of disease
• SURGICAL COHORT: Patients must be deemed medically stable to undergo both percutaneous procedures and standard-of-care surgical procedures by their treating surgeon
• SURGICAL COHORT: Participants must have undergone multi-parametric prostate MRI that both assesses the extent of disease and allows the research team to assess for study eligibility. This will have been done as part of the standard-of-care. Abnormal imaging will be correlated with the biopsy findings to maximize the likelihood of the device being put in the lesion. If the images are not adequate, the MRI scan will be repeated at Brigham and Women’s Hospital (BWH)/Dana Farber Cancer Institute (DFCI), again as part of standard-of-care management
• SURGICAL COHORT: The participant’s case must be reviewed by representatives of urologic oncology and interventional radiology to assess the following factors: * Patient is clinically stable to undergo biopsy procedure(s) and surgical procedures * Patient has sufficient volume of disease as shown by MRI to allow implantation of the microdevice * A lesion can be selected where the microdevice is to be implanted that is a) amenable to percutaneous placement, and b) amenable to removal at the time of primary surgery
• SURGICAL COHORT: Patients must be willing to undergo research-related genetic sequencing (somatic and germline) and data management, including the deposition of de-identified genetic sequencing data in National Institutes of Health (NIH) central data repositories
• SURGICAL COHORT: For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm during the treatment period and for 28 days after the last dose of ipatasertib

Exclusion Criteria

• EX VIVO COHORT: Unwillingness to sign informed consent
• SURGICAL COHORT: Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit the safety of a biopsy and/or surgery
• SURGICAL COHORT: Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or biopsy procedures