Phase 2 Prostate Cancer 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:
- Participants must have signed a consent form before taking part in the study.
- Participants must be adults aged 18 or older.
- Participants must have a reasonable level of physical functioning, rated on a standard medical scale from 0 (fully active) to 2 (able to care for oneself but unable to carry out physical work) — (confirm with trial site).
- Participants must have prostate cancer that has been confirmed by a tissue sample as a specific type called adenocarcinoma.
- For one part of the trial (Phase Ib): having had up to one round of a certain type of chemotherapy (taxane-based) in the past is allowed. For another part (Phase II): participants must not have received that type of chemotherapy for advanced prostate cancer that no longer responds to hormone treatment, though it may have been used at an earlier stage.
- Participants must have cancer that shows up on a specific type of scan called a PSMA-PET scan, using an approved imaging agent, and must meet the trial's central review requirements.
- Participants must have very low testosterone levels (below 50 ng/dL) and/or be receiving hormone-suppressing treatment (ADT).
- Participants must have been diagnosed with prostate cancer that has spread and no longer responds to hormone treatment (mCRPC), and must have shown signs of the cancer growing or spreading while on a specific type of hormone therapy (ARPI) — with progression confirmed by rising PSA levels, growth of soft-tissue tumours, or new bone disease lesions.
Who may not be able to join:
- Participants who are currently receiving, or have received within the last 28 days, certain treatments directed at the prostate or cancer-fighting treatments given throughout the body (such as hormone therapy, chemotherapy, immunotherapy, or radioligand therapies).
- Participants who have previously received any radioligand therapy (RLT) or any treatment that specifically targets PSMA, whether approved or experimental.
- Participants who have taken part in another clinical trial and received an experimental treatment within the 28 days before starting this study.
- Participants who have serious ongoing medical conditions that could interfere with the study procedures or follow-up visits.
- Participants with a history of cancer spread to the brain are not automatically excluded, but must have already completed treatment for it (such as surgery or radiation), and must be neurologically stable, without symptoms, and not taking steroid medications to manage brain-related symptoms.
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
3 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Phase Ib: Incidence rate of Dose-limiting toxicities (DLTs); Phase Ib: Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs); Phase Ib: Number of Participants with dose adjustments; Phase Ib: Dose Intensity; Phase Ib: Duration of exposure to each study drug; Phase II: Biochemical Response (PSA50)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.