Phase 2 Spinal Muscular Atrophy Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are a man aged 18 or older who has been diagnosed with prostate cancer that has spread to other parts of the body (such as bones or soft tissue), either newly diagnosed or returning after previous treatment, and your cancer does not have certain rare, aggressive features (called neuroendocrine or small cell features).
- Your testosterone levels have been reduced to very low levels (called "castrate levels") through hormone treatment.
- You are reasonably active and able to carry out daily activities, ranging from fully active to capable of limited self-care (confirm with trial site for exact definition).
- Your blood counts and organ function (such as kidneys and liver) are at acceptable levels, as determined by tests.
- You started hormone-blocking therapy (called ADT) at least 1 month but no more than 12 months before joining the study, and you are willing to continue it during the trial.
- You may have previously received a type of chemotherapy called a taxane for this condition, as long as your cancer did not progress while on it (certain limits apply depending on which part of the trial you join).
- You may have previously taken a type of hormone therapy called an ARPI (androgen receptor pathway inhibitor), under certain conditions depending on when and how long you took it (confirm with trial site for details specific to your situation).
- You may have previously had radiation therapy or surgery to the prostate, provided radiation was completed before joining and surgery was at least 2 weeks before joining.
Who may not be able to join:
- Your prostate cancer has become resistant to hormone therapy (known as castration-resistant prostate cancer, or CRPC), or you only have a rising PSA without confirmed spread to other parts of the body, or your cancer is not causing symptoms and has not spread and your PSA has been normal for at least 1 year.
- Your PSA level is very low — specifically below 0.5 ng/mL if you have not had prior ARPI treatment, or below 0.2 ng/mL if you have had or are currently on ARPI treatment.
- Your cancer has spread to the brain, unless you have already been treated for it, your condition is stable, you have no symptoms, and you are not taking steroids to manage brain-related symptoms (confirm with trial site).
- You are currently taking older-generation hormone-blocking drugs called first-generation anti-androgens (such as bicalutamide), unless you only took them briefly (14 days or less) at the very start of hormone therapy and stopped at least 7 days before joining.
- You are taking a drug called ketoconazole specifically to treat your prostate cancer.
- You have previously received a type of treatment called radioligand therapy.
- You have taken part in another clinical trial and received an experimental treatment within the past 28 days (or longer, depending on the drug).
- You have previously been treated with a specific class of drugs called PRC2 inhibitors (including EZH2 inhibitors or similar), which target a particular cancer-related process (confirm with trial site).
- You have used herbal products known to lower PSA levels within 4 weeks before starting the study drug.
- You are taking certain medications (such as strong CYP3A4 inducers or inhibitors) or herbal products that could interfere with the study drug and cannot be safely stopped before and during the trial (confirm with trial site for a full list of prohibited medications).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Phone: 1-888-669-6682
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
2 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Phase I (Group A and Group B): Dose-limiting toxicities (DLTs); Phase I (Group A and Group B): Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs); Phase I (Group A and Group B): Number of Participants with dose adjustments; Phase I (Group A and Group B): Dose Intensity; Phase I (Group A and Group B): Duration of exposure to each study drug; Phase II (Group A): Prostate-Specific Antigen (PSA) response rate of < 0.2 ng/mL
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.