RecruitingPhase 2NCT03522064

Bipolar Androgen Therapy + Carboplatin in mCRPC

High Dose Testosterone + Carboplatin in Men With Advanced Prostate Cancer


Sponsor

St Vincent's Hospital, Sydney

Enrollment

30 participants

Start Date

Jul 30, 2018

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying a combination of bipolar androgen therapy (alternating very high and very low testosterone doses) plus carboplatin (a chemotherapy drug) in men with advanced prostate cancer that no longer responds to standard hormone therapy and has a specific DNA repair defect. **You may be eligible if...** - You are a male 18 or older diagnosed with prostate cancer - Your cancer has a confirmed defect in DNA repair (called HRD — homologous recombination deficiency) - Your PSA (prostate-specific antigen) blood levels are rising despite having very low testosterone from hormone therapy - Your testosterone level is very low (castrate levels) and you are currently on hormone therapy or have had surgical castration for at least 1 year - Your blood counts, liver, kidney, and heart function are within acceptable ranges **You may NOT be eligible if...** - You have pain from your prostate cancer that requires opioid pain medications - Your cancer is actively progressing in ways that make this approach unsafe - You have contraindications to either treatment drug - Your organ function is outside the required ranges Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTestosterone Enanthate 100 MG/ML Injectable Solution

Testosterone 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.

DRUGTestosterone Enanthate 100 MG/ML Injectable Solution / Carboplatin AUC 5

Testosterone 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


Locations(1)

Kinghorn Cancer Centre, St. Vincent's Hospital

Sydney, New South Wales, Australia

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NCT03522064


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