Focal Therapy Combined with Androgen Deprivation Therapy for the Treatment of Localized Intermediate Risk Prostate Cancer

Inclusion Criteria

• Subjects must have intermediate-risk prostate cancer (PCa) as defined by the below criteria: * Favorable intermediate-risk PCa: ** ≤ clinical stage T2c, grade group 2 (GG2), and prostate-specific antigen (PSA) ≤ 10 ng/mL, and < 50% positive biopsy cores with PCa * Unfavorable intermediate-risk PCa: ** ≤ clinical stageT2c, GG2, and PSA 10-20 ng/mL, or ≥ 50% positive biopsy cores with PCa, or ** ≤ clinical stage T2c, grade group 3 (GG3), and PSA < 20 ng/mL *** Note: The PSA value for this inclusion criteria must be the value obtained just prior to the subject’s magnetic resonance imaging targeted biopsy (MRI-TB) that provided the initial histopathologic diagnosis. This is considered to be the subject’s “baseline” PSA. *** If the MRI-TB which initially diagnosed the subject’s PCa was obtained greater than 3-months from the time of study consent, then a repeat PSA should be completed for screening purposes to obtain a “baseline” PSA (unless one has been obtained for SOC at least 3-months after this initial biopsy in which case no repeat value is needed and this may be used for eligibility). This applies to all participants regardless of grade group (GG) used for eligibility. *** Note: The histopathologic diagnosis must be obtained via “MRI-TB”, which for the purposes of the present study, is defined as both a systematic 12-core sextant random prostate biopsy and a targeted prostate biopsy. The targeted prostate biopsy can be performed via in-bore mpMRI prostate biopsy, cognitive mpMRI/ultrasound fusion prostate biopsy or software mpMRI/ultrasound fusion prostate biopsy. This “MRI-TB” must not be obtained greater than 1 year from the date of consent
• No multiparametric (mp)MRI evidence of extra-prostatic extension (EPE) or seminal vesicle invasion, and if seminal vesical invasion is suspected, it must be excluded by prostate biopsy.
• Subjects must have chosen to get focal therapy for the treatment of prostate cancer
• Subjects must have confirmed non-metastatic PCa following standard of care (SOC) screening for patients with unfavorable intermediate-risk PCa, a combination of computed tomography imaging of the abdomen and pelvis (CTAP) and technetium-99-mDP nuclear medicine bone scan (BS) and/or prostate-specific membrane antigen positron emission tomography (PSMA/PET) scan prior to enrollment. The imaging studies should be obtained within 6-months of enrollment. Additional imaging is not required for men with favorable intermediate-risk PCa
• Subject must be male ≥ 18 years-old
• Subjects must have a life expectancy of at least 10-years per the opinion of the treating investigator
• Subjects must be designated as Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 or Karnofsky Performance Status Scale Score ≥ 60%)
• Subjects must be fit to undergo general anesthesia and the focal therapy ablation of the prostate (FT) surgical procedure, which includes adequate visualization of the prostate gland on transrectal ultrasound imaging, access to the urethra, perineum and rectum, as well as be tolerant of lithotomy positioning in the opinion of the treating investigator or the operating surgeon(s) if not the same as the treating investigator
• Hemoglobin ≥ 10 g/dL
• Leukocytes ≥ 3,000/mcL
• Absolute neutrophil count ≥ 1,500/mcL
• Platelets ≥ 100,000/mcL
• Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
• Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamic-pyruvate transaminase [SGPT]) ≤ 2.5 × institutional ULN
• Creatinine < 1.5 institutional ULN OR calculated or measured creatinine clearance > 50 mL/min/1.73 m^2
• Estimated glomerular filtration rate (eGFR) > 30 mL/min using the MDRD (modification of diet and renal disease) formula
• Serum albumin ≥ 3.0 g/dL
• Serum potassium ≥ 3.5 mmol/L
• Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
• Subjects who are sexually active with a woman of childbearing potential must agree to use a condom with spermicidal foam/gel/film/cream/suppository and his partner must also be practicing a highly effective method of contraception (i.e., established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system) during treatment and for 3-months following the last androgen deprivation therapy (ADT) treatment
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Subject has had prior or current PCa therapies, such as biologic, chemotherapy, hormone therapy, radiotherapy or surgery for PCa. Subjects may not have had undergone pelvic radiation, chemotherapy or immunotherapy treatment for a separate hematologic or visceral malignancy within 6-months of enrollment in the present study
• Subjects with locally advanced, nodal or metastatic prostate cancer
• Subjects who are unfit for pelvic mpMRI scanning (e.g., severe claustrophobia), permanent cardiac pacemaker, metallic implants that are likely to contribute to significant image artifacts, allergy or contraindication to gadolinium contrast agent
• History of allergy or intolerance to study drug components
• History of bilateral orchiectomy
• If the subject has an uncontrolled or major debilitating inter-current illness
• Subjects who are receiving any other investigational agents, or who have received other investigational agents in the past and who are no longer receiving these investigational agents may be eligible at the discretion of the principal investigator (PI)
• Judgment by the treating investigator or PI that the subject is unsuitable to participate in the study and the subject is unlikely to comply with study procedures, restrictions, and requirements