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 prostate cancer that has spread to other parts of the body and continues to grow despite having very low testosterone levels (a condition called metastatic castration-resistant prostate cancer, or mCRPC), shown by rising PSA levels or new growths visible on scans.
• People whose cancer has been treated with at least one, but no more than two, courses of a chemotherapy type called taxane (for at least 2 treatment cycles), or who a doctor has determined are not suitable for a second taxane course due to frailty or intolerance.
• People whose cancer has continued to grow after receiving at least one hormone-blocking drug, such as abiraterone or enzalutamide.
• People who are able to understand the study information and are willing to sign a consent form, and who are able to follow all trial procedures and attend follow-up visits.
• People aged 18 to 90 years (inclusive).
• People whose doctors estimate they are expected to live for more than 6 months.
• People with a general health and activity level that falls within a certain range, as assessed by a standard medical scale (ECOG performance status of 2 or below — confirm with trial site).
• People whose scans using a specific type of imaging (68Ga-PSMA-11 PET/CT) show areas of the cancer that absorb enough of the scan tracer to meet the trial's threshold.
• People who have at least one tumour or bone spread that can be measured or identified on scans according to standard criteria.
• People whose blood test results show that their bone marrow, liver, and kidneys are functioning at or above the levels required by the trial.
• People who are willing to follow radiation safety measures as required during the trial.

Who may not be able to join:

• People who are unable to tolerate or complete the imaging procedures required by the trial.
• People who have received cancer treatments such as chemotherapy, radiation, or immunotherapy (not including hormone therapy) within the 4 weeks before the first dose, or who have taken part in another experimental drug or device study in that time.
• People who have received certain radioactive treatments (such as Radium-223 or Lutetium-177) within the past 6 months, or external beam radiation therapy within the past 2 months.
• People who are still experiencing severe bone marrow side effects from previous cancer treatment that have not resolved within the required timeframes.
• People who plan to use certain other cancer treatments, such as chemotherapy or immunotherapy, during the trial.
• People who received blood transfusions or albumin (a blood protein) in the 14 days before blood tests done to check eligibility.
• People who have cancer that has spread to the brain, except in certain limited circumstances (confirm with trial site).
• People who have had another type of cancer within the past 5 years, except for certain skin cancers that have been fully cured.
• People whose bone scan shows a particular pattern called a "superscan," which suggests very widespread bone involvement (confirm with trial site).
• People who have symptoms of, or are at immediate risk of, spinal cord compression.
• People who have previously had radiation therapy covering a large portion of their bone marrow (more than 25%).
• People with certain serious heart conditions, including a history of long QT syndrome, or a heart attack, chest pain condition, or bypass surgery within the past 6 months (as assessed by the trial team).
• People with any other condition that, in the trial doctor's judgment, could affect safety or the reliability of the trial results.
• People with uncontrolled difficulty urinating, urinary leakage, claustrophobia (fear of enclosed spaces), or radiophobia (fear of radiation) at the time of screening.
• People who test positive for hepatitis C, HIV, or syphilis.
• People who are hepatitis B surface antigen positive and have active hepatitis B virus activity confirmed by testing.
• People with a known allergy to the components of the trial treatment or similar substances.
• People with a history of drug or alcohol misuse within the past year, or ongoing substance dependence.
• People who are unwilling or unable to use effective contraception throughout the trial and for 6 months after the last dose.
• People who have a severe active infection at the time of the first dose.

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