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 18 years of age or older.
• People whose general health and ability to carry out daily activities meets a certain fitness level (confirm with trial site).
• People who have been confirmed through a tissue sample (biopsy) to have prostate cancer of a specific type called adenocarcinoma.
• People whose prostate cancer shows up strongly on a specialised scan called a PSMA PET/CT scan, with a specific level of activity in the prostate tumour (confirm with trial site), and where this scan was done within the last 4 months.
• People who meet at least one of the following disease spread criteria:
  • Cancer that has spread to lymph nodes in the pelvis or the region around the main blood vessels in the lower abdomen, seen on imaging.
  • In the absence of lymph node spread, people who have at least 2 of the following: cancer that has grown beyond the prostate into nearby tissue (seen on MRI or PSMA PET/CT scan); a high cancer aggressiveness score (Grade Group 4 or higher); or a PSA blood level of 40 ng/mL or above.
• People whose blood tests show that their bone marrow, kidneys, and liver are functioning well enough to receive treatment (specific blood test thresholds apply — confirm with trial site).
• People whose urinary symptoms score is 15 or below on a standard prostate symptom questionnaire.
• People who are considered medically suitable for treatment and are willing to attend follow-up appointments.
• People who are able to understand and willing to sign a written consent form.
• People with a partner who could become pregnant must agree to use a condom during the study and for 14 weeks after the last dose of treatment, and must not donate sperm during that same period.

Who may not be able to join:

• People whose cancer has spread to distant parts of the body, including lymph nodes above the main abdominal blood vessel (aorta), bones, or other organs.
• People whose prostate gland is larger than 90 cc as measured by CT, ultrasound, or MRI.
• People who have previously had radiation therapy to the head or neck area.
• People who have previously received any treatment for prostate cancer, including chemotherapy, radiation, or hormone-blocking therapy.
• People who have taken certain medications — including spironolactone or other investigational drugs — within the 30 days before starting the study.
• People who have taken certain medications — including oral ketoconazole, oestrogens, or radioactive drug treatments — within the 3 months before joining or who would need them during the study.
• People who have previously had radiation therapy to the pelvis.
• People currently enrolled in another clinical drug trial, or who were enrolled in one within the past 6 months.
• People who have had another active cancer in the past 3 years, except for certain treated skin cancers or a superficial type of bladder cancer.
• People with a history of certain blood or bone marrow disorders (myelodysplastic syndrome or acute leukaemia).
• People with a history of, or currently living with, Crohn's disease or ulcerative colitis.
• People who are unable to have a PSMA PET/CT scan for any reason.
• People who are unable to follow radiation safety precautions in hospital or at home.
• People who have previously been treated with any radioactive drug therapy, including the treatment used in this trial.
• People who already have significant dry mouth problems before the trial starts.
• People with any other condition that the trial doctor considers would make participation unsuitable.

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