Phase 1 Liver 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 through a tissue sample (biopsy).
• People whose prostate cancer has continued to grow or spread, as measured by specific medical criteria (called PCWG3) at the time of joining.
• Male participants who are 18 years of age or older at the time of signing the consent form.
• People whose testosterone levels in the blood are at very low ("castrate") levels (below 50 ng/dL). Those who have not had both testicles surgically removed must continue hormone-blocking injections throughout the trial.
• People whose cancer previously got worse while taking at least one newer type of hormone-blocking medication, such as abiraterone, apalutamide, darolutamide, or enzalutamide.
• People whose side effects from prior cancer treatments (not counting hormone-blocking injections) have mostly resolved — generally to mild or no symptoms — before joining (with exceptions for hair loss and certain nerve-related symptoms).
• People who have had external beam radiotherapy, provided the last session was more than 2 weeks before starting the trial, and all side effects from radiation have resolved.
• People who have at least one area of cancer outside the liver that shows up on a specific type of scan called a PSMA PET scan.
• People who have stored tissue samples from their prostate cancer, or who have a cancer lesion that could be biopsied and are willing to have a biopsy during the screening period if no stored tissue is available.
• People who have one or more liver tumours that a specialist doctor (interventional radiologist) considers suitable for direct liver treatment.
• People who are reasonably physically functional, as assessed by standard medical scoring tools (confirm with trial site).
• People whose blood test results show that their bone marrow, liver, and kidneys are working at an adequate level, as defined by specific thresholds across several tests (confirm with trial site for exact values).
• People who have previously treated brain tumours (metastases) may still be eligible, provided their last brain treatment was more than 28 days before starting the trial and a recent MRI shows no new or worsening brain tumours.
• People who are willing and able to use effective contraception during the trial and for at least 6 months after the last treatment dose (confirm with trial site for accepted methods).
• People who are able to understand the trial and are willing to sign a written consent form.

Who may not be able to join:

• People who were originally diagnosed with a specific rare type of prostate cancer called small cell neuroendocrine prostate cancer from the start (de novo).
• People who have one or more cancer lesions outside the liver (such as enlarged lymph nodes or other soft tissue spots) that do not show up on a PSMA PET scan.
• People who have received other systemic (whole-body) cancer treatments within 14 days, or within 5 half-lives of that treatment, before starting the trial — except for hormone-blocking injections, which are still allowed.
• People who have previously received a type of cancer treatment that targets PSMA using radioactive particles (radioligand therapy).
• People who have received more than 2 rounds of taxane-based chemotherapy (such as docetaxel or cabazitaxel) while their cancer was in the castration-resistant stage.
• People who have had certain past procedures involving the bile ducts or surrounding structures, including a bilio-enteric anastomosis, sphincterotomy of the ampulla of Vater, or a biliary stent or drain passing through the ampulla of Vater (confirm with trial site if unsure).
• People who are currently taking part in another clinical trial using an experimental treatment, or who have used an experimental medical device within the past 4 weeks.
• People with serious heart conditions, including severe heart failure, uncontrolled chest pain, a heart attack, stroke, or unstable angina within the past 6 months, or a significant heart rhythm problem not controlled by medication.
• People who have had major surgery within 28 days before starting the trial, or who have not yet fully recovered from a recent surgery.
• People who have another cancer that currently requires active treatment (with some exceptions, such as certain skin cancers or non-invasive bladder cancer).
• People who have an active infection that requires intravenous (drip) antibiotics within 7 days before starting the trial.
• People with a known history of active Hepatitis B or Hepatitis C infection, unless specific conditions have been met — such as completing antiviral treatment and having an undetectable viral load (confirm with trial site).
• People who are not suitable for the liver-directed part of the treatment, for example because of uncontrolled bleeding risk or significant fluid build-up in the abdomen (ascites) requiring repeated drainage.
• People who are unwilling or unable to follow radiation safety precautions required after each dose of radioligand therapy or liver-directed therapy.
• People who have any other condition that, in the trial doctor's judgement, would prevent them from safely following the trial procedures.

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