RecruitingPhase 2

Bipolar Androgen Therapy + Carboplatin in mCRPC

Australia30 participantsStarted 2018-07-30

Plain-language summary

The purpose of this study is to determine the efficacy of BAT and carboplatin in men with metastatic castrate-resistant prostate cancer (mCRPC).

Age range18 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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)

✕. 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.
✕. Life expectancy of less than 3 months.
✕. Brain metastases or leptomeningeal disease
✕. History of thromboembolic event and not currently on anticoagulation
✕. Prior myocardial infarction or unstable angina within 2 years of study entry

PSA Response Rate

Timeframe: 1 year

NCT IDNCT03522064

SponsorSt Vincent's Hospital, Sydney

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

Robert Kent

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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)

✕. 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.
✕. Life expectancy of less than 3 months.
✕. Brain metastases or leptomeningeal disease
✕. History of thromboembolic event and not currently on anticoagulation
✕. Prior myocardial infarction or unstable angina within 2 years of study entry