Study on Copanlisib and Degarelix for Treating Prostate Cancer

Inclusion Criteria

• Must be willing and able to provide written consent and allow access to personal health information.
• Men aged 18 and older with prostate cancer.
• Must have confirmed prostate cancer through lab tests.
• Must have high-risk localized prostate cancer, defined by:
  • PSA level over 20 ng/ml, or
  • Gleason score of 8 or higher, or
  • Clinical stage of cT3a or higher.
• Must know PTEN status:
  • PTEN loss for certain participants.
  • PTEN intact for others, if applicable.
• Must be a candidate for surgery as determined by a doctor.
• Must have a performance status score of 2 or less, indicating ability to carry out daily activities.
• Must have normal organ function and acceptable lab results:
  • Neutrophil count of at least 1.5 K/mcL.
  • Hemoglobin level of at least 9 g/dL.
  • Platelet count of 100 K/mcL or less.
  • Creatinine level within 1.5 times the normal limit.
  • Potassium level within normal range.
  • Total bilirubin within 1.5 times the normal limit (exceptions for Gilbert's syndrome).
  • Liver enzymes (AST and ALT) within 2.5 times the normal limit.
  • Kidney function (GFR) of at least 30 mL/min/1.73 m².
• Must agree to use effective birth control or abstain from sex during the study and for 5 months after the last treatment.

Exclusion Criteria

• Evidence of prostate cancer spread beyond the pelvis on scans.
• On hormone therapy for more than 4 weeks at the time of consent.
• Previous radiation treatment to the prostate.
• Uncontrolled high blood pressure or heart disease that prevents participation.
• Diabetes requiring medication or high blood sugar levels (HgbA1C over 7).
• Any other active cancer requiring treatment, except for certain skin or bladder cancers.
• Use of certain medications or supplements that may interact with the study drugs within 2 weeks before starting treatment.
• Participation in another clinical trial or use of investigational drugs within 4 weeks or longer, depending on the drug.
• Known allergy to the study drugs.
• Any other condition that, in the investigator's opinion, prevents participation.