Phase 2 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:

• People who have been diagnosed with prostate cancer confirmed by a tissue or cell sample, including less common types such as neuroendocrine, small cell, or sarcomatoid prostate cancer.
• People who have measurable or detectable cancer that has spread to other parts of the body, based on standard imaging guidelines.
• People who have a tissue sample available that was collected within the past 12 months (a sample from a site where cancer has spread is preferred, but a sample from the original prostate tumour is also acceptable).
• People who have had genetic testing of their cancer performed through a certified laboratory using a next-generation sequencing test, as part of their standard care.
• People aged 18 or older.
• People whose prostate cancer has continued to grow or spread despite having very low testosterone levels (below 50 ng/dL), shown by rising PSA levels, new or worsening spots on imaging scans, or new bone spread.
• People being considered for a specific treatment called lutetium Lu 177 vipivotide tetraxetan must have cancer that shows a particular protein marker (PSMA) on imaging scans, as assessed by the treating doctor.
• People who have previously been treated with a type of hormone therapy called an androgen receptor signalling inhibitor. People must also have received taxane chemotherapy unless their doctor determined they were not suitable for it or they chose not to have it. People with certain inherited or acquired gene mutations in BRCA1 or BRCA2 must have previously received a PARP inhibitor treatment.
• People whose side effects from previous cancer treatments have largely resolved, with only mild or stable ongoing effects such as chemotherapy-related nerve pain, fatigue, or certain hormone-related conditions (confirm with trial site for details on what counts as acceptable ongoing side effects).
• People who are generally well enough to carry out light activity and care for themselves, rated 0, 1, or 2 on the ECOG performance scale (a standard measure of overall health and daily functioning).
• People whose blood counts and organ function meet the required levels, including: white blood cell count of at least 2,500 per microlitre, neutrophil count of at least 1,500 per microlitre, haemoglobin of at least 9 g/dL, platelet count of at least 100,000 per microlitre, kidney function (creatinine clearance) of at least 30 mL/min, liver enzyme levels (AST and ALT) no more than 3 times the upper limit of normal, total bilirubin no more than 1.5 times the upper limit of normal (or up to 3 times for people with a condition called Gilbert's disease), and albumin of at least 2.8 g/dL.
• People who have not had a blood or platelet transfusion, or white blood cell growth factor injections (GCSF), in the 2 weeks before joining the trial.
• People who have previously received cabazitaxel combined with carboplatin chemotherapy.
• People who, after completing a treatment assigned by the trial's molecular review board, have cancer that has continued to grow or spread (for those seeking to re-join the trial after an initial treatment period).

Who may not be able to join:

• People who have received certain cancer treatments recently: chemotherapy, biological therapies, radiopharmaceuticals, or certain investigational treatments within 4 weeks before joining; small molecule targeted therapies within 2 weeks; specific hormone drugs (abiraterone, apalutamide, or darolutamide) within 2 weeks; enzalutamide within 4 weeks; or radiation therapy within 2 weeks.
• People who have had major surgery within 4 weeks before joining the trial.
• People who have previously been treated with a type of drug called an EZH inhibitor.
• People who are currently taking moderate or strong CYP3A-inducing medicines (a type of medication that can affect how other drugs are broken down in the body) (confirm specific medicines with trial site).
• People with a known allergy or sensitivity to the study drug valemetostat tosylate or any of its ingredients.
• People with active hepatitis B virus infection that is not controlled with treatment, or hepatitis C infection that has not been successfully treated and cleared.
• People living with HIV must have an undetectable viral load on their current HIV treatment within the past 6 months to be considered.
• People with cancer pressing on or damaging the spinal cord, or where this is considered to be at risk of happening soon.
• People with cancer that has spread to the brain or the tissue around the brain, unless it has been fully treated with radiotherapy or surgery and has been stable for at least 4 weeks, and all wounds have fully healed.
• People with significant heart problems, including: a heart attack within the past 6 months, uncontrolled chest pain (angina) within the past 6 months, moderate to severe heart failure (New York Heart Association Class 3 or 4), a specific abnormality in heart electrical activity (QTcF interval of 470 ms or more on an ECG) in people with any history of heart disease or relevant medications, or uncontrolled high blood pressure (resting systolic above 160 mmHg or diastolic above 100 mmHg).
• People with a serious active infection requiring intravenous or systemic antibiotic, antifungal, or antiviral treatment.
• People with severe liver disease (Child-Pugh Class C).
• People with a known bleeding disorder.
• People who have frozen or donated sperm within 14 days before joining the trial.

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