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:

• Adults aged 18 or older.
• People with a general health status rated at a certain level, meaning they are reasonably able to carry out daily activities (confirm with trial site for specific performance status rating).
• People who have been diagnosed with prostate cancer (a specific type called adenocarcinoma), confirmed by a tissue biopsy.
• People whose PSA level (a prostate cancer marker measured by a blood test) is 1.0 ng/ml or above at the start of the trial.
• People who have not previously received hormone-blocking therapy (such as surgical removal of the testicles or hormone injections) as treatment for returning or spreading prostate cancer — though hormone therapy given alongside radiation treatment more than one year before the cancer returned may be acceptable.
• People who have not previously been treated with certain newer hormone-targeting drugs (abiraterone, enzalutamide, or darolutamide) for returning or spreading prostate cancer — though use alongside radiation treatment more than one year before the cancer spread may be acceptable.
• People who have had targeted radiation to a small number of cancer spots (called oligometastatic disease) more than 6 months ago, provided there is also evidence of cancer spread in areas that were not irradiated.
• People whose PSA blood test results show a rising level on two separate tests taken more than two weeks apart.
• People with confirmed evidence of cancer that has spread, shown on a CT scan or bone scan done within six weeks of the screening period.
• People experiencing bone pain caused by prostate cancer may be considered, but must be free of that pain by the end of the first six months of the trial to continue to the next stage of treatment.
• People who have soft tissue tumours that can be safely biopsied must agree to have biopsies taken at the start of the trial and again at six months.
• People whose liver function blood test results are within an acceptable range (below 2.5 times the normal upper limit for certain liver markers).
• People whose kidney function blood test results are within an acceptable range (below 2.5 times the normal upper limit for creatinine).
• People whose blood counts are within acceptable ranges, including white blood cells, platelets, and haemoglobin levels (confirm specific values with trial site).
• People who are able to understand the trial information and are willing to sign a consent form.

Who may not be able to join:

• People who have previously received chemotherapy.
• People who have previously been treated with a drug called Pluvicto or any other treatment that targets a protein called PSMA.
• People who have previously been treated with any experimental drug targeting the androgen receptor.
• People with serious or unstable medical or psychiatric conditions that could affect their safety or ability to take part.
• People whose cancer spread, in the treating doctor's judgement, would make testosterone-based therapy risky — for example, cancer near the spine, near the femur (thigh bone), or in lymph nodes in positions that could cause complications.
• People who need to use a self-inserted urinary catheter to urinate due to blockage caused by prostate cancer or a non-cancerous enlarged prostate — though people with a permanently placed catheter for obstruction may still be eligible.
• People with an active, uncontrolled infection.
• People with any condition or cognitive difficulty that may affect their ability to safely take part or give informed consent, as determined by the treating doctor.
• People taking the blood-thinning medication Warfarin or Coumadin — though people taking other types of blood thinners (such as Lovenox, Eliquis, or Xarelto) may be eligible, and people on Coumadin who are able to switch to another blood thinner before starting the trial may also be eligible.
• People with a haematocrit (red blood cell concentration) above 51%, untreated severe sleep apnoea, or poorly controlled heart failure.
• People with a known allergy to sesame seed oil or cottonseed oil.
• People who have had major surgery within the three weeks before screening, or who have not fully recovered from a previous surgery.
• People with significant heart problems, including a certain level of heart failure (classified as NYHA class III or IV), or those who have had a heart attack within the last five years.
• People who are unable to give informed consent.

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