Copanlisib in Combination with Degarelix in Treating High-Risk Localized Prostate Cancer prior to Radical Prostatectomy, The CHARIOT Trial

Inclusion Criteria

• Willing and able to provide written informed consent and privacy authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed
• Individuals with prostate cancer 18 years of age and above
• Histological or cytological evidence of prostate cancer
• Documented high-risk localized prostate cancer based on one or more of the following National Comprehensive Cancer Network (NCCN) criteria: * Prostate-specific antigen (PSA) > 20ng/ml or * Gleason ≥ 8 or * Clinical stage ≥ cT3a
• Known PTEN status: * PTEN loss by IHC for participants in the PTEN loss cohort * PTEN intact by IHC for participants in the exploratory PTEN intact cohort (only available if PTEN intact cohort is opened)
• Candidate for RP as determined by treating physician
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Absolute neutrophil count (ANC) ≥ 1.5 K/mcL (within 28 days of registration)
• Hemoglobin ≥ 9g/dL (within 28 days of registration)
• Platelet count ≥ 100 K/mcL (within 28 days of registration)
• Creatinine ≤ 1.5 x the institutional upper limit of normal (ULN) (within 28 days of registration)
• Potassium within institutional normal range (within 28 days of registration)
• Total Bilirubin ≤ 1.5 x ULN (Note: In participants with Gilbert’s syndrome, if total bilirubin is > 1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 × ULN, participant may be eligible) (within 28 days of registration)
• Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate transaminase [AST]) ≤ 2.5 x ULN (within 28 days of registration)
• Serum glutamic-pyruvic transaminase (SGPT) (alanine transaminase [ALT]) ≤ 2.5 x ULN (within 28 days of registration)
• Glomerular filtration rate (GFR) (Modification of Diet in Renal Disease [MDRD]) ≥ 30 mL/min/1.73 m^2 (within 28 days of registration)
• Participants must agree to use a medically acceptable method of birth control (i.e., spermicide in conjunction with a barrier such as a condom) or sexual abstinence prior to registration, for the duration of study participation and for at least 5 months after the last treatment with copanlisib

Exclusion Criteria

• Radiographic evidence of distant (extra-pelvic) metastatic prostate cancer on CT and/or MRI, bone scan or PET scan
• On androgen deprivation therapy (ADT) (gonadotropin-releasing hormone agonist [GnRH] agonists or antagonists) for > 4 weeks at time of consent
• Prior radiation to prostate
• Medical conditions such as uncontrolled hypertension or cardiac disease that would, in the opinion of the investigator preclude participation in this protocol
• A diagnosis of diabetes (type 1 or 2) on medications for the purpose of treating hyperglycemia or hemoglobin A1C (HgbA1C) > 7 will be excluded from study
• Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 3 years prior to first dose of study treatment that requires active treatment, except for basal or squamous cell skin cancer or superficial bladder cancer that has previously been treated
• Use of any prohibited concomitant medications including herbal supplements within 2 weeks prior to treatment start
• Receiving any other investigational agents within 4 weeks or 5x the half-life of investigational agent (whichever is longer) from this study’s treatment start
• Known allergy to any of the compounds under investigation
• Any other condition which, in the opinion of the Investigator, would preclude participation in this trial