High Dose Testosterone + Carboplatin in Men With Advanced Prostate Cancer
The purpose of this study is to determine the efficacy of BAT and carboplatin in men with metastatic castrate-resistant prostate cancer (mCRPC).
• Males with histologically confirmed adenocarcinoma of the prostate
• 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.
• Age ≥ 18 years
• ECOG performance status ≤ 1
• Rising PSA confirmed on two sequential tests ≥1 week apart and a minimum value of 2 ug/L despite castrate levels of testosterone
• Serum testosterone \< 1.7 nmol/L and on an LHRH agent or post orchidectomy ≥ 1 year.
• Washout of ≥ 4 weeks from prior line of treatment, radiotherapy or surgery (aside from LHRH agent)
• Adequate bone marrow function (platelets \> 100 x 109/L, ANC \> 1.5 x 109/L, Hb \>100)
• Adequate liver function (ALT/AST \< 1.5 x ULN, bilirubin \< 2 x ULN)
⁃ Adequate renal function (creatinine clearance \> 50 ml/min)
⁃ Adequate cardiac function and reserve after cardiology assessment
⁃ Archived tissue sample available or willingness to undergo fresh biopsy
⁃ Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments
⁃ Signed, written informed consent