Phase 1 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 and is no longer responding to hormone therapy (confirmed by a tissue or cell sample).
• People aged 18 years or older.
• People who are willing and able to sign a consent form and follow the study requirements.
• People with a life expectancy of more than 3 months.
• People who have at least one area of cancer detected on a specific type of scan called a PSMA-PET/CT scan.
• People whose cancer has been assessed by the study doctor as continuing to grow or progress.
• People who are generally well enough to carry out light daily activities, rated 0 or 1 on a standard medical fitness scale (ECOG scale).
• People whose testosterone levels are kept very low (below 50 ng/dL or 1.7 nmol/L) through hormone-lowering medication or prior surgical removal of the testicles.
• People who have previously been treated with at least one of the following types of hormone-blocking drugs: an androgen receptor blocker (such as enzalutamide) or a testosterone production blocker (such as abiraterone acetate).
• People who have previously received at least 1 but no more than 2 courses of a chemotherapy type called taxane. People who were unwilling to receive taxane treatment due to concerns about side effects may also be considered after careful review by the study doctor (confirm with trial site).
• People whose blood counts and organ function meet the required levels, including adequate white blood cells, red blood cells, platelets, protein levels, liver function, kidney function, and a normal heart rhythm measurement (confirm specific values with trial site).

Who may not be able to join:

• People who have cancer that has spread to the brain.
• People who have a severe bladder inflammation (Grade 3 cystitis), whether due to infection or another cause.
• People with serious medical, mental health, or laboratory conditions that the study doctor believes would make participation unsafe or affect the study results.
• People who have previously received more than one treatment with a PSMA-targeted radioactive drug (a drug that delivers radiation directly to cancer cells using a targeting molecule).
• People who have previously received certain other types of radioactive treatments (Actinium-225, Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, or whole-body radiation therapy), except for two specific treatments: Lutetium-177 PSMA-617 or Radium-223.
• People who received a treatment called Radium-223 within the 6 months before the start of the study treatment.
• People who received any radioactive drug treatment within 6 weeks before the start of the study treatment, or who still have significant side effects from a previous radioactive drug treatment.
• People who have had more than 6 doses of any previous radioactive drug treatment.
• People who have had any cancer-fighting drug treatment (such as chemotherapy, immunotherapy, or similar medications) within 6 weeks before the study treatment starts. People who have been on a stable dose of bone-strengthening medication (bisphosphonate or denosumab) for at least 30 days may still be considered eligible.
• People whose bone scan shows a specific pattern called a "superscan," which suggests very widespread bone involvement.
• People who have taken part in another experimental drug study within 6 weeks before the study treatment starts.
• People who have had radiation therapy covering more than 30% of their bone marrow within the last 6 weeks, or targeted radiation to a specific area within the last 2 weeks.
• People who have had major surgery within 6 weeks before the study treatment starts, or who have not yet recovered from a recent surgery.
• People who have spinal cord compression or signs that spinal cord compression may be developing.
• People who are known to have an allergy or sensitivity to the study drug or similar substances.
• People who are currently enrolled in another interventional clinical trial.
• People who have ongoing dry mouth or dry eyes as a lasting side effect of a previous treatment.
• People who still have significant ongoing side effects (above Grade 1) from previous cancer treatments.
• People with serious heart conditions, including a heart attack or unstable chest pain within the past 6 months, severe heart failure, uncontrolled high blood pressure, uncontrolled irregular heartbeat, or severe narrowing of the heart's aortic valve.
• People who have had a blood clot, stroke, mini-stroke, or similar circulatory event within the 6 months before the study treatment starts.
• People who have a known active infection requiring treatment, including HIV, active hepatitis B, active hepatitis C, or active COVID-19.
• People who have been diagnosed with a different cancer (other than the one being studied) within the past 3 years before the study treatment starts.
• People with a known history of a bone marrow disorder called myelodysplastic syndrome.

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