Actively Recruiting

Phase 2
Age: 18Years +
MALE
NCT03522064

Bipolar Androgen Therapy + Carboplatin in mCRPC

Led by St Vincent's Hospital, Sydney · Updated on 2026-04-23

30

Participants Needed

1

Research Sites

491 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Bipolar Androgen Therapy + Carboplatin in mCRPC

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male patients with confirmed prostate adenocarcinoma
  • Confirmed homologous recombination deficiency (HRD) by validated genetic testing
  • Age 18 years or older
  • ECOG performance status of 0 or 1
  • Rising PSA on two tests at least one week apart with a minimum value of 2 ug/L despite low testosterone
  • Serum testosterone below 1.7 nmol/L and on LHRH therapy or post orchidectomy for at least 1 year
  • At least 4 weeks washout from prior treatments except LHRH agents
  • Adequate bone marrow function (platelets > 100 x 10^9/L, ANC > 1.5 x 10^9/L, hemoglobin > 100)
  • Adequate liver function (ALT/AST less than 1.5 times upper limit, bilirubin less than 2 times upper limit)
  • Adequate kidney function (creatinine clearance above 50 ml/min)
  • Adequate cardiac function confirmed by cardiology assessment
  • Archived tissue sample available or willingness for fresh biopsy
  • Willing and able to comply with all study requirements and assessments
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Contraindications to the investigational treatment
  • Pain from metastatic prostate cancer requiring opioid painkillers
  • Disease progression posing risk from testosterone therapy (e.g., risk of fracture, obstruction, or spinal cord compression)
  • Prior platinum chemotherapy or PARP inhibitor treatment (except up to 8 men in exploratory cohort)
  • Life expectancy under 3 months
  • Brain or leptomeningeal metastases
  • History of blood clots without current blood thinners
  • Heart attack or unstable angina within 2 years
  • Hematocrit 50% or higher, untreated severe sleep apnea, or poorly controlled heart failure
  • Another cancer diagnosis within past 5 years, except some treated skin or bladder cancers
  • Severe infections or illnesses that may jeopardize safety
  • Psychological, social, or geographic issues that may affect study compliance, including alcohol or drug abuse

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Kinghorn Cancer Centre, St. Vincent's Hospital

Sydney, New South Wales, Australia, 2010

Actively Recruiting

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Research Team

R

Robert Kent

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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