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:

• Men aged 18 or older who are able to read, understand, and sign a consent form agreeing to take part in the study.
• Men who agree not to donate sperm during the treatment period and for at least 195 days after the last dose, and who agree to either remain completely abstinent from sex with women, or use a condom during any sexual contact with a woman who could become pregnant (with the additional recommendation that the female partner also use a reliable form of contraception).
• People diagnosed with prostate cancer that has spread to other parts of the body (metastatic), confirmed by biopsy or laboratory testing, and detected by imaging scans such as PET-CT, CT, MRI, or bone scan.
• People whose prostate cancer has continued to grow despite having very low testosterone levels (a condition called castration-resistant prostate cancer, or CRPC).
• People who have already received and seen their cancer progress through certain hormone-blocking treatments (called novel anti-androgen therapies) and one or two rounds of chemotherapy based on a drug type called taxanes.
• People whose cancer shows measurable disease on imaging, a rising PSA blood test result on two separate tests at least one week apart (with the most recent result at or above 2 ng/mL), or two or more spots of cancer visible on a bone scan.
• People whose cancer has been confirmed to be getting worse on their most recent cancer treatment.
• People who have very low testosterone levels (below 50 ng/dL), either because they have had both testicles surgically removed or because they are receiving ongoing hormone-suppressing treatment, which must have been started at least four weeks before joining the study.
• People who are generally well enough to carry out everyday activities with no more than minor limitations (as measured by a standard medical scale called ECOG performance status 0 or 1), with no worsening in the two weeks before starting treatment.
• People who are able to provide a tumour tissue sample — either a fresh biopsy or stored (archival) tissue — for testing of a protein called PSMA and other biological markers.
• People whose blood test results show that their liver, kidneys, and other organs are functioning adequately (confirm specific values with trial site).

Who may not be able to join:

• People whose prostate cancer has features of a specific type called small cell or neuroendocrine carcinoma, or any type other than adenocarcinoma.
• People who have had cancer spread to the brain or spinal cord lining.
• People who have been diagnosed with another invasive cancer within the last five years — with some exceptions, such as certain skin cancers, superficial bladder cancer, or early-stage breast cancer that was successfully treated, or any cancer that was fully treated and has been in remission for at least two years and is not expected to interfere with this study.
• People who still have significant side effects from previous cancer treatments that have not improved to near-normal levels (with some exceptions such as hair loss, mild nerve damage, or hormone conditions managed with replacement therapy).
• People with a history of autoimmune disease (where the immune system attacks the body) that required ongoing medical treatment within the two years before screening — though some conditions managed only with hormone replacement, such as thyroid or insulin treatment, may not be disqualifying (confirm with trial site).
• People with a history of, or current evidence of, lung inflammation not caused by infection (called interstitial lung disease or non-infectious pneumonitis) that required steroid treatment.
• People who have received any anti-cancer therapy, including immunotherapy, within four weeks before starting the study.
• People who have received a type of targeted radiation therapy directed at a protein called PSMA within two months before starting the study, unless they received fewer than two cycles of that treatment.
• People who have previously received certain advanced immune-based therapies targeting PSMA or other prostate cancer-related proteins, including CAR-T cell therapy or T cell engager treatments.
• People who have previously had a bone marrow transplant or any solid organ transplant.
• People with a known allergy or sensitivity to the study drug or any of its ingredients.
• People with a history of severe neurological or psychiatric conditions — such as epilepsy, dementia, or major depression — that could interfere with taking part in the study.
• People who have had major surgery within four weeks before starting the study.
• People who have had a serious infection within four weeks before starting the study, or who are still receiving antibiotic treatment through a drip (IV) within two weeks, or oral antibiotics within one week, before the first dose (people on preventive antibiotics may still be eligible — confirm with trial site).
• People whose liver enzyme (ALT) blood test results are too high — more than 2.5 times the upper limit of normal, or more than 5 times if liver spread has been documented.
• People whose bilirubin blood level is above 1.5 times the upper limit of normal.
• People with serious liver disease, such as cirrhosis or unstable liver or bile duct problems shown by symptoms like fluid build-up in the abdomen, confusion, jaundice, or abnormal blood clotting.
• People who test positive for Hepatitis B at screening or within three months before the first dose.
• People who test positive for Hepatitis C antibodies or Hepatitis C virus (RNA) at screening or within three months before the first dose, unless a follow-up test confirms the infection has fully resolved (confirm with trial site).
• People who are unable to follow the study schedule, attend required visits, or meet all study requirements as assessed by the study doctor.

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