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 are willing and able to sign a written consent form agreeing to take part and allowing their health information to be used for research purposes.
• Men aged 18 years or older.
• Men whose blood testosterone level is at or above 150 ng/dL, unless they are already on hormone-suppressing treatment for prostate cancer.
• Men whose bone marrow, liver, and kidney are functioning well enough, based on blood tests taken within 28 days before starting treatment (the trial site can confirm the specific values required).
• Men who have had their prostate cancer stage assessed by a urologist or cancer specialist within 90 days before starting treatment, using a standard medical staging system that includes physical examination and/or imaging such as ultrasound, CT scan, or MRI.
• Men who, in the opinion of their treating doctor, are suitable candidates for surgical removal of the prostate along with removal of nearby lymph nodes.
• Men who agree to use a condom (even after a vasectomy) plus another effective form of contraception during the study and for 3 months after the last dose of the study drug if having sex with a woman who could become pregnant, or to use a condom if having sex with a woman who is already pregnant; and men who agree not to donate sperm during the study and for 3 months after the last dose.
• Men who have a prostate abnormality visible on an MRI scan of the prostate.

Who may not be able to join:

• People who have previously had prostate surgery, surgical removal of pelvic lymph nodes, radiation therapy, or targeted local treatment for prostate cancer or a non-cancerous prostate condition.
• People who have been receiving certain hormone-suppressing treatments (GnRH antagonist or agonist) and/or certain anti-androgen drugs for more than 12 weeks before enrolling.
• People who have previously received chemotherapy for prostate cancer.
• People who have received any experimental treatment for prostate cancer within 30 days before the planned start of the study drug.
• People who are known to have cancer that has spread to the brain, liver, lungs, or other internal organs (spread to certain pelvic or abdominal lymph nodes may be acceptable — confirm with trial site).
• People who have previously had other treatments aimed at reducing or eliminating prostate cancer that has spread, beyond what is described above.
• People who currently have another cancer, or who have had another cancer diagnosed within the last 5 years that still requires active treatment or is in remission with a life expectancy of less than 5 years — with some exceptions for certain low-risk skin, bladder, head and neck, or bowel cancers (confirm with trial site).
• People with a significant health condition other than cancer that could make participation unsafe or difficult, including any of the following:
  • A medical condition requiring a higher dose of steroid medication than a low daily dose of prednisone or prednisolone (confirm with trial site).
  • A current active infection that requires treatment through a drip or tablets.
  • A history of stomach or bowel problems — whether medical or due to major surgery — that could affect how the study drug is absorbed by the body.
  • Uncontrolled high blood pressure (above certain levels — confirm with trial site); people with high blood pressure that is well controlled by medication may still be eligible.
  • Current active hepatitis B or hepatitis C infection.
  • Moderate or severe liver disease (confirm with trial site).
  • People living with HIV who are not on effective HIV treatment, who have recently changed their HIV treatment, whose HIV treatment may interact with the study drug, whose immune cell count is below a certain level, or who have had a serious HIV-related infection within the past 6 months (confirm with trial site for full details).
  • A history of problems with the pituitary gland or adrenal glands.
  • Significant heart disease, including a heart attack or blood clot in an artery in the past 6 months, severe or unstable chest pain, a low heart pumping function, serious heart rhythm problems within the past 6 months, or advanced heart failure.
  • A history of seizures, or any condition that increases the risk of seizures — such as a recent stroke, temporary stroke-like episode, or loss of consciousness within the past year, or certain abnormalities or growths in the brain.
  • A history of inflammatory bowel disease, such as Crohn's disease or ulcerative colitis.
  • Use of any additional medications that the investigator believes could affect how the immune system responds to treatment.
• People who have used certain medications that are not permitted alongside the study's hormone treatments within 14 days before starting treatment (medications known to lower the seizure threshold must be stopped or changed at least 4 weeks before starting).
• People who have a known allergy or sensitivity to certain prostate cancer drugs used in this trial, including apalutamide, enzalutamide, darolutamide, or GnRH agonists or antagonists.
• People who are unable to have an MRI scan.
• For a specific group within the trial (Cohort B): people who have significant symptoms caused by local or spreading prostate cancer.

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