Bipolar androgen therapy in men with metastatic castration-resistant prostate cancer after progression on enzalutamide: an open-label, phase 2, multicohort study.
Benjamin A Teply, Hao Wang, Brandon Luber...
https://pubmed.ncbi.nlm.nih.gov/29248236Actively Recruiting
Phase 2
Age: 18Years +
MALE
ID03522064
High Dose Testosterone and Carboplatin Treatment in Men With Advanced Prostate Cancer
Led by St Vincent's Hospital, Sydney · Updated on 2026-04-23
30
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of bipolar androgen therapy (BAT) combined with carboplatin in men who have metastatic castrate-resistant prostate cancer (mCRPC). This condition progresses despite low testosterone levels, and while androgen deprivation therapy (ADT) is standard, resistance develops over time. The study explores whether cycling testosterone levels can improve responses, particularly in men with DNA repair defects. Participants receive high dose testosterone enanthate injections of 500mg intramuscularly every 4 weeks alongside continuous LHRH therapy or after surgical removal of the testes, plus carboplatin chemotherapy dosed at AUC 5. This combination is being studied in a phase 2 trial to assess how well it works and its safety. During the study, men's prostate-specific antigen (PSA) levels will be monitored over one year to evaluate treatment response. Imaging and safety assessments will also occur to track disease progression and side effects. Participants must comply with scheduled visits, lab tests, and biopsies as part of the study, which is sponsored by St Vincent's Hospital in Sydney.
CONDITIONS
Brief Title
Bipolar Androgen Therapy + Carboplatin in mCRPC
Who Can Participate
Age: 18Years +
MALE
Eligibility Criteria
You may qualify if you...
- Male with confirmed prostate adenocarcinoma
- Confirmed homologous recombination defect (HRD) by validated testing
- Age 18 years or older
- ECOG performance status 0 or 1
- Rising PSA confirmed on two tests at least 1 week apart, minimum 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 agent
- Adequate bone marrow, liver, kidney, and cardiac function
- Available tissue sample or willingness for biopsy
- Able to comply with study treatments and assessments
- Signed informed consent
You will not qualify if you...
- Contraindications to study treatment
- Pain requiring opioid analgesics
- Disease progression posing risk from testosterone therapy (e.g., unstable bone metastases, ureteric obstruction, spinal cord compression)
- Prior platinum chemotherapy or PARP inhibitor treatment (except up to 8 men in exploratory cohort)
- Life expectancy less than 3 months
- Brain or leptomeningeal metastases
- History of thromboembolic event without anticoagulation
- Recent myocardial infarction or unstable angina within 2 years
- High hematocrit, severe sleep apnea, or poorly controlled heart failure
- Another cancer within 5 years except some treated skin or bladder cancers
- Severe infection or concurrent illness affecting safety
- Psychological or social conditions affecting compliance, including alcohol or drug abuse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 1 year
Participants receive high dose testosterone injections every 4 weeks in combination with ongoing LHRH therapy or post-orchidectomy plus Carboplatin chemotherapy as per standard procedures.
Monthly visits for injections and assessments
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
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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Published Research Related To This Trial
Bipolar Androgen Therapy for Men With Androgen Ablation Naïve Prostate Cancer: Results From the Phase II BATMAN Study.
Michael T Schweizer, Hao Wang, Brandon Luber...
https://pubmed.ncbi.nlm.nih.gov/27338150Harnessing cell-free DNA: plasma circulating tumour DNA for liquid biopsy in genitourinary cancers.
Manuel Caitano Maia, Meghan Salgia, Sumanta K Pal
https://pubmed.ncbi.nlm.nih.gov/32203306