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 given written consent to take part in the trial.
• People aged 18 or older.
• People with a general health and activity level rated as reasonably functional (scored 0–2 on a standard oncology scale called ECOG — confirm with trial site if unsure what this means for a specific situation).
• People who have chosen active surveillance (monitoring without immediate treatment) as their prostate cancer management approach.
• People who have a prostate lesion visible on MRI that scores 3 or higher on standard rating scales used by radiologists, and if the score is exactly 3, the lesion must be at least 10mm in size.
• People whose prostate cancer has been confirmed through a combination of MRI-guided targeted biopsies and standard systematic biopsies, where the biopsy results and MRI findings are consistent with each other.
• People who are not expected to need surgery for urinary/bladder outlet problems during the treatment period or in the 12 months of follow-up afterward.
• People whose recent blood test results meet all of the following standards (these would need to be confirmed by the trial site):
  • Red blood cell levels (haemoglobin) at an acceptable level without recent transfusions or growth factor support.
  • Platelet count within an acceptable range without recent transfusion support.
  • White blood cell (neutrophil) count at an acceptable level.
  • Blood protein (albumin) levels at an acceptable level.
  • Kidney function (measured by a filtration rate and a protein called creatinine) within acceptable limits.
  • Potassium levels in the blood within an acceptable range.
  • Liver enzyme and bilirubin levels within acceptable limits (a special consideration applies for people with a condition called Gilbert's syndrome — confirm with trial site).
• People whose prostate cancer falls into one of these categories:
  • Grade Group 2 cancer (a standard pathology grading — confirm with trial site).
  • Grade Group 1 cancer with a higher-than-normal PSA density reading AND a lesion rated 4 or 5 on MRI scoring scales that is at least 10mm in size.
  • Grade Group 1 cancer with a higher-than-normal PSA density reading AND where 50% or more of the biopsy samples taken contain cancer cells (with specific counting rules applying for certain MRI-scored lesions — confirm with trial site).

Who may not be able to join:

• People who have a known allergy or medical reason to avoid the study drug apalutamide or any of its ingredients.
• People who have metal implants in the pelvis area that would interfere with getting a clear prostate MRI.
• People who have previously used or are currently using hormone therapies that lower testosterone (androgen deprivation therapy) or other drugs that target androgen receptors (note: established use of a specific class of medications called 5-ARIs for urinary symptoms is not excluded — confirm with trial site).
• People who have received any systemic (whole-body) treatment for prostate cancer.
• People who are unable to have a prostate MRI scan for any reason.
• People who are already taking part in another clinical trial involving an investigational medicine (participation in observation-only studies is acceptable).
• People who have had a seizure, or have a condition that may increase the risk of seizures — including stroke, mini-stroke (TIA), loss of consciousness, certain brain blood vessel abnormalities, or certain brain tumours causing swelling, within the past year.
• People who are currently taking medications known to lower the seizure threshold or cause seizures, unless those medications can be stopped or switched at least 28 days before joining the trial.
• People who, in the opinion of the trial doctor, are considered to be at an increased risk of falls or bone fractures.
• People who have had serious heart or blood vessel events in the past 6 months, including severe chest pain (angina), heart attack, heart failure with symptoms, blood clots in the lungs, stroke, or significant heart rhythm problems. People with risk factors such as high blood pressure, diabetes, or high cholesterol would need those conditions to be well managed before joining.
• People with high blood pressure that is not controlled by medication (specifically, systolic pressure of 160 mmHg or higher, or diastolic pressure of 90 mmHg or higher).
• People with a gut or digestive condition that affects how medications are absorbed.
• People who are taking certain medications known to affect heart rhythm in a specific way (called QT prolongation), including certain heart rhythm drugs, methadone, a specific antibiotic called moxifloxacin, or certain antipsychotic medications — unless those medications can be stopped and cleared from the body (a minimum washout period applies — confirm with trial site).
• People showing symptoms that may suggest a serious and rare skin reaction called Stevens-Johnson syndrome or toxic epidermal necrolysis.

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