Working Out M0 Bipolar Androgen Therapy

Inclusion Criteria

• •1. Histologically confirmed adenocarcinoma of the prostate
• •2. ≥18 years of age
• •3. ECOG performance status 0-1
• •4. PSA progression while on darolutamide defined as three rising PSA (1 baseline and 2 consecutive rises) levels at least 1 week apart despite castrate testosterone level (\<1.7nmol/L). Patients with a minor subsequent PSA fall, provided there was no intervening therapy since the three consecutive rises, are eligible
• •5. AJCC stage M0 on conventional imaging.
• •1. Previous PSMA PET only M1 disease in the hormone-sensitive setting that is now M0 CRPC on conventional imaging following \>18 months of ADT + darolutamide are eligible.
• •2. Nodes up to 2cm in short-axis in pelvis are permitted
• •6. PSA \>1.0 ng/mL during screening
• •7. Serum testosterone \<1.7nmol/L and on an LHRH agonist/antagonist
• •8. Adequate bone marrow function (platelets \> 100 x 109/L, ANC \> 1.5 x 109/L, Hb \>90)
• •9. Adequate liver function (ALT or AST \< 2.5 x ULN, bilirubin \< 1.5 x ULN)
• •10. Adequate renal function (creatinine \<1.5 x ULN)
• •11. Willingness and ability to comply with study requirements, including treatment and timing of treatment.
• •7. Concurrent illness that could preclude the participant's ability to participate in the study and follow protocol with reasonable safety.
• •8. Planned ongoing drug Interactions as per protocol section 5.2.4 that are considered unable to be managed prior to study registration.