High Dose Testosterone + Carboplatin in Men With Advanced Prostate Cancer

Who is this study for? Adult patients with metastatic castration-resistant prostate cancer and homologous recombination deficiency
What treatments are being studied? Testosterone Enanthate+Carboplatin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Australia
Kinghorn Cancer Centre, St. Vincent's Hospital
RECRUITING
Sydney
Contact Information
Primary
Robert Kent
SVHS.CancerResearch@svha.org.au
+61293555611
Time Frame
Start Date: 2018-07-30
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 30
Treatments
Experimental: High dose testosterone + Carbolplatin
500mg IM enanthate every 4 weeks in combination with ongoing LHRH agent (unless post-orchidectomy) plus Carboplatin AUC 5
Related Therapeutic Areas
Sponsors
Leads: St Vincent's Hospital, Sydney

This content was sourced from clinicaltrials.gov

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