Bipolar Androgen Therapy + Carboplatin in mCRPC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorSt Vincent's Hospital, Sydney
About this trial
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
Qualifiers
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
Disqualifiers
Contraindications to investigational product
Pain due to metastatic prostate cancer requiring opioid analgesics
Evidence of disease progression in sites or extent that, in the opinion of the investigator, would put the patient at risk from testosterone therapy and its potential for initial tumour flare (eg: femoral metastasis at risk of fracture, ureteric obstruction due to nodal disease or cord compression due to spinal metastases).
Previous treatment with platinum chemotherapy and/or a PARP inhibitor. However up to 8 men with prior treatment to these agents will be included as an exploratory cohort.
Trial design
Treatments tested in this trial
- Testosterone Enanthate 100 MG/ML Injectable Solution
- Testosterone Enanthate 100 MG/ML Injectable Solution / Carboplatin AUC 5
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov