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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Testosterone Enanthate 100 MG/ML Injectable Solution
DrugTestosterone Enanthate is the oil-soluble ester of the androgenic hormone testosterone. Testosterone Enanthate is a clear to pale yellow solution for intramuscular injection. Each pre-filled syringe contains 250mg testosterone enanthate/1mL.
Testosterone Enanthate 100 MG/ML Injectable Solution / Carboplatin AUC 5
DrugTestosterone Enanthate is the oil-soluble ester of the androgenic hormone testosterone. Testosterone Enanthate is a clear to pale yellow solution for intramuscular injection. Each pre-filled syringe contains 250mg testosterone enanthate/1mL. Carboplatin as per standard procedures
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: High dose testosterone + CarbolplatinExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
PSA Response Rate
\>/= 50% fall from baseline PSA
Time frame
1 yearSecondary outcomes
1
Time to PSA progression
Time to increase in PSA \>/=25% from baseline or nadir confirmed on subsequent test \>1 week later
Time frame
1 year2
Radiological Response Rate
RECIST or PCWG3 Criteria
Time frame
1 year3
Safety and Tolerability (Frequency of adverse events as assessed by NCI CTCAE v4.0)
Frequency of adverse events as assessed by NCI CTCAE v4.0
Time frame
1 yearOther outcomes
1
Changes in ctDNA expression from baseline
Exploratory
Time frame
1 year2
Change in serum testosterone and oestradiol levels
Change in serum levels from baseline to Days 14 and 28 of cycle 1
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov