Phase 2 Prostate Cancer Trial, Recruiting

Written by an AI model from the 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 that has spread to other parts of the body (metastatic), confirmed by a tissue biopsy showing a specific type of cancer called adenocarcinoma.
• People whose cancer is getting worse, shown by either a significant rise in a blood marker called PSA (measured at least twice, three weeks apart), or by new or growing spots seen on scans in organs, lymph nodes, or bones.
• For the first part of the trial (dose escalation): People whose prostate cancer has stopped responding to hormone treatments (called castration-resistant) and who have previously had at least one type of hormone-blocking tablet (called an ARPi) and chemotherapy with taxanes — unless taxane chemotherapy was medically unsuitable or declined by the patient and this is recorded in their medical notes.
• For the second part of the trial (dose expansion), one of the following groups may apply:
  • Group 1: People whose prostate cancer still responds to hormones but whose PSA blood level remains at 0.2 or above despite receiving hormone therapy (ADT) and a hormone-blocking tablet (ARPi), with no signs the cancer is actively progressing on scans.
  • Group 2: People whose castration-resistant prostate cancer has progressed after at least one ARPi tablet, who have never received a treatment called Lutetium-177 PSMA therapy, and who have not had chemotherapy for castration-resistant prostate cancer.
  • Group 3: People whose castration-resistant prostate cancer has progressed and who have previously received both Lutetium-177 PSMA therapy and an ARPi tablet.
• People whose cancer tests positive for a specific protein called PSMA, confirmed by a specialised type of scan (a PSMA PET/CT scan using either Gallium-68 or Fluorine-18), and assessed as eligible by a local scan reader.
• People who are generally well enough to carry out daily activities with little or no limitation, based on a standard medical fitness scale (ECOG score of 0 or 1).
• People with adequate blood counts and acceptable kidney and liver function.

Who may not be able to join:

• People who have previously received a radioactive drug treatment aimed at cancer cells, except for a treatment called Radium-223. (Note: previous Lutetium-177 PSMA therapy is actually required for Group 3 participants — confirm details with the trial site.)
• People who have received cancer treatments (including radiotherapy) or any experimental treatment within four weeks before the first trial treatment date.
• People who have had another type of cancer (other than prostate cancer) in the past three years, unless that cancer had very little risk of spreading.
• People who have cancer that has spread to the brain or spinal cord, or who are experiencing symptoms suggesting pressure on the spinal cord. People who were previously treated for spinal cord compression may be considered if they have been stable without steroids for at least four weeks (confirm with trial site).
• People whose cancer has spread very extensively throughout the bone marrow, sometimes called a "superscan," which is identified on a specific type of bone scan.
• People with a serious active or underlying infection, chest pain from reduced blood flow to the heart (angina), significant heart failure, a dangerously irregular heart rhythm, or another serious illness that could interfere with taking part in the trial or that might interact with the trial treatment.
• People who carry a known change in a gene called BRCA1 or BRCA2, and where their treating doctor's hospital considers them eligible to receive a type of treatment called a PARP inhibitor as part of standard care.

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