Bipolar Androgen Therapy + Carboplatin in mCRPC
Trial Parameters
Brief Summary
The purpose of this study is to determine the efficacy of BAT and carboplatin in men with metastatic castrate-resistant prostate cancer (mCRPC).
Eligibility Criteria
Inclusion Criteria: 1. Males with histologically confirmed adenocarcinoma of the prostate 2. Confirmed HRD (Homologous recombination defect) in germline and/or somatic DNA analysis (tumour or blood), by a validated assay (see Appendix 1). Mutations in HR genes not listed in appendix 1 will be considered in literature suggests pathogenicity. A maximum of 10 uncharacterised or heterozygous mutations will be included. 3. Age ≥ 18 years 4. ECOG performance status ≤ 1 5. Rising PSA confirmed on two sequential tests ≥1 week apart and a minimum value of 2 ug/L despite castrate levels of testosterone 6. Serum testosterone \< 1.7 nmol/L and on an LHRH agent or post orchidectomy ≥ 1 year. 7. Washout of ≥ 4 weeks from prior line of treatment, radiotherapy or surgery (aside from LHRH agent) 8. Adequate bone marrow function (platelets \> 100 x 109/L, ANC \> 1.5 x 109/L, Hb \>100) 9. Adequate liver function (ALT/AST \< 1.5 x ULN, bilirubin \< 2 x ULN) 10. Adequate renal function (creatinine clearanc