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 are able to understand and sign a consent form agreeing to take part in the study.
• People who are able to follow all the requirements of the study.
• People who are 18 years of age or older.
• People who are reasonably active and able to care for themselves, based on a standard medical scale that rates physical ability from 0 (fully active) to 2 (up and about more than half of waking hours).
• People who are expected to live for more than 6 months.
• People who have had their prostate cancer confirmed through a tissue or cell sample analysis.
• People whose most recent PSMA PET/CT scan (a specialised type of imaging that looks for cancer using a radioactive tracer) shows positive results, with no areas of cancer that do not show up on this scan, as assessed by the nuclear medicine specialist at the trial site.
• People whose PSMA PET/CT scan shows a whole-body tumour activity score below a specific threshold (a "whole body SUVmean" of less than 10), as calculated by the nuclear medicine specialist using specialised software (confirm with trial site).
• People who have previously had surgical removal of the testicles and/or are currently on hormone therapy to lower testosterone, with testosterone levels confirmed to be at a very low (castrate) level at the most recent check before joining.
• People who have previously been treated with at least one type of hormonal drug that blocks androgen receptors, such as enzalutamide or abiraterone.
• People whose prostate cancer has spread to other parts of the body (metastatic) and is continuing to grow or spread despite castrate testosterone levels (this is called metastatic castration-resistant prostate cancer, or mCRPC), shown by at least one of the following: rising PSA levels on two consecutive tests, growth of existing tumours or appearance of new ones on scans, or new areas of cancer appearing on a bone scan.
• People who have at least one area of cancer spread visible on a CT scan, MRI, or bone scan done within 45 days before starting the study.
• People who have recovered from significant side effects of previous cancer treatments, with any remaining side effects being mild to moderate at most.
• People whose blood test results meet minimum levels for white blood cells, infection-fighting cells (neutrophils), platelets, haemoglobin (a measure of red blood cell health), liver function markers, albumin (a protein in the blood), kidney function, and bilirubin (a liver waste product), as defined by the trial requirements (confirm specific values with the trial site).
• People living with HIV who are in good health, considered low risk for HIV-related illness, and whose HIV viral load has been undetectable on anti-HIV medication within the past 6 months.
• People who have a partner who could become pregnant must use an acceptable form of contraception during the study and for 14 weeks after the last dose of study treatment, and must not donate sperm during treatment and for 14 weeks after the last treatment.
• People with a history of hepatitis B virus (HBV) infection must have an undetectable viral load while on appropriate suppressive treatment if required; people with a history of hepatitis C virus (HCV) infection must have been successfully treated and cured, or if currently being treated, must have an undetectable HCV viral load.

Who may not be able to join:

• People who have received certain bone-targeting radioactive treatments (Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, or Radium-223) or radiation to large areas of the body within the 6 months before the study start, or who have previously received any PSMA-targeted radioligand therapy.
• People who have received any systemic anti-cancer treatment (such as chemotherapy, immunotherapy, or biological therapies including monoclonal antibodies) within 30 days before the study start. (Note: bone-protecting medications such as bisphosphonates or denosumab are allowed.)
• People who have taken part in another experimental drug study within 30 days before the study start.
• People who have a known allergy or sensitivity to the study treatment or similar substances.
• People currently receiving other chemotherapy, immunotherapy, radioligand therapy, or experimental treatments at the same time as this trial.
• People who have had a blood transfusion within 30 days before the study start.
• People who have cancer that has spread to the brain or spinal cord covering (CNS metastases), unless it has been treated, is neurologically stable, causes no symptoms, and no steroid medication is needed to manage it; people with certain types of spinal involvement may still be considered if that area has been treated and is stable (confirm with trial site).
• People who are experiencing symptoms from spinal cord compression, or whose scans suggest spinal cord compression may be about to occur.
• People with serious ongoing medical conditions, including severe heart failure (New York Heart Association class III or IV), a history of a specific inherited heart rhythm condition (congenital prolonged QT syndrome), uncontrolled infection, active hepatitis B or C, or other significant health conditions that the investigator believes would prevent safe participation in the trial.

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