Brief Summary
The purpose of this study is to determine the efficacy of BAT and carboplatin in men with metastatic castrate-resistant prostatea walnut-shaped gland in the male reproductive system that is responsible for producing semen - a bodily fluid that acts as a vessel for sperm transport during ejaculation cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs (mCRPC).
Intervention / Treatment
- Drug: Testosterone Enanthate 100 MG/ML Injectable Solution
- Drug: Testosterone Enanthate 100 MG/ML Injectable Solution / Carboplatin AUC 5
Inclusion Criteria
- Males with histologically confirmed adenocarcinomacancer arising from mucus-producing glands in organs of the prostate
- Confirmed HRD (Homologous recombination defect) in germline and/or somatic DNA analysis (tumoura tissue mass that forms from groups of unhealthy cells or bloodthe red bodily fluid that transports oxygen and other nutrients around the body), 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 orchidectomyremoval of one or both testicles, also known as orchiectomy ≥ 1 year.
- Washout of ≥ 4 weeks from prior line of treatment, radiotherapy or surgerytreatment involving removal of cancerous tissue and/or tumours and a margin of healthy tissue around it to reduce recurrence (aside from LHRH agent)
- Adequate bone marrowsoft, spongy tissue found in bones that makes blood cells function (plateletssmall disc-shaped blood cells that clump together to form clots to stop bleeding > 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 tissuea group of cells that work together to perform a function sample available or willingness to undergo fresh biopsyremoval of a section of tissue to analyse for cancer cells
- Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments
- Signed, written informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment.