Phase 1 Prostate Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older
• People who are fully active or have only minor restrictions in physical activity, as measured by a standard oncology performance scale (called ECOG score 0 or 1)
• Male participants diagnosed with metastatic castration-resistant prostate cancer (a form of prostate cancer that has spread and no longer responds to standard hormone-lowering treatment), meeting specific medical definitions
• People whose cancer spread (metastases) has been confirmed by bone scan, CT scan, or MRI — a positive result on a PSMA-PET scan alone is not enough to confirm eligibility
• People willing to have a small tissue sample (biopsy) taken from a site where cancer has spread, before and during treatment, if it is safe to do so — if a suitable biopsy was already taken within the past 6 months, that sample may be used instead
• People whose cancer continued to grow during or after treatment with a specific class of hormone-blocking drugs (called ARPIs, such as abiraterone, enzalutamide, darolutamide, or apalutamide)
• People whose kidneys are working well enough, based on a standard blood test result
• People whose liver is working well enough, based on standard blood test results
• People whose blood counts (white blood cells, platelets, and haemoglobin) are within acceptable ranges, with no blood transfusions in the past two weeks

Who may not be able to join:

• People with brain metastases that are causing symptoms or are not well controlled — unless the condition has been treated, does not require steroid medications, and has been stable for at least 28 days; people with cancer that has spread to the lining of the brain or spinal cord are not eligible under any circumstances
• People with spinal cord compression that is causing symptoms or is expected to worsen soon, and has not been treated or stabilised
• People with serious or life-threatening illness, active uncontrolled infection, or other conditions that the trial doctor believes could put the participant at risk or affect the reliability of trial results
• People who still have significant side effects from previous cancer treatment that have not largely resolved — with the exception of hair loss and moderate nerve-related side effects, which are allowed
• People with active, uncontrolled bacterial, fungal, or viral infections, including active hepatitis B, hepatitis C, HIV, or AIDS-related illness — people with previously treated hepatitis B or C that now shows no detectable virus in the blood may still be eligible; eligibility for people living with HIV who are on effective treatment will be assessed on a case-by-case basis by the trial medical team
• People with a significant history of serious heart, kidney, lung, liver, neurological, psychiatric, hormonal, immune, or metabolic conditions that the trial doctor believes would make participation unsafe — this includes certain heart rhythm or electrical problems, a heart attack within the past 3 months, heart failure of a certain severity, active chest pain from the heart, or blood pressure that remains above 150/90 mmHg despite treatment
• People currently taking or expected to need certain medications that strongly affect how the trial drug is processed by the body (strong CYP3A inducers or inhibitors) — confirm specific medications with the trial site
• People who have received other cancer treatments — including radiation, hormone-targeting drugs, or chemotherapy — within 2 to 4 weeks before starting the trial, depending on the type of treatment
• People who have participated in another clinical trial involving an experimental treatment within the past 4 weeks
• People who have had major surgery within 28 days before starting the trial, or who have not yet fully recovered from a recent major surgery
• People who start new hormone-based treatments aimed at prostate cancer during the study period — stable, long-term use (6 months or more) of a specific type of hormone medication called 5-alpha reductase inhibitors is permitted
• People who have used certain herbal products or alternative therapies that may affect PSA levels or have hormone-like effects on prostate cancer (such as saw palmetto, St. John's wort, or grape seed extract) within 4 weeks of starting the trial, or who plan to use them at any point during the study
• For one specific part of the trial only (the part combining KTX-2001 with darolutamide): people currently taking or expected to need certain medications that affect how darolutamide is processed by the body (combined P-gp and moderate to strong CYP3A4 inducers) — confirm specific medications with the trial site

Important: Always verify eligibility with the trial site directly before applying.