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 give informed consent before any study procedures begin, and who are willing to follow all study requirements.
• Men aged 18 or older.
• People who have a confirmed diagnosis of prostate cancer that has either spread to other parts of the body or cannot be surgically removed, and where the cancer has continued to grow despite hormone-lowering treatment (castration-resistant prostate cancer, or CRPC) — shown by rising PSA levels, growth on scans, or new lesions appearing on imaging.
• People whose cancer has shown up as positive on a special type of scan called a PSMA PET scan, meaning at least one cancer lesion outside the pelvis shows higher uptake than the liver.
• People whose cancer has progressed after treatment with hormone-suppressing therapy (ADT) and at least one hormone-blocking medication such as enzalutamide, apalutamide, darolutamide, or abiraterone.
• People who have previously received up to 6 doses of a lutetium-177 PSMA treatment (such as Pluvicto), or up to 4 doses in an investigational setting — though prior lutetium treatment is not required to join.
• People who have previously received up to one course of taxane-based chemotherapy (at least two cycles), though this is also not required.
• People whose cancer has continued to grow during or after their most recent cancer treatment.
• People who are generally well enough to carry out light activity and care for themselves, as assessed by a standard medical scale (ECOG performance status of 0 or 1).
• People who, in the treating doctor's opinion, have a life expectancy of at least 4 months.
• People who could father a child must agree to use highly effective contraception during the study and for 6 months after the last dose, and must agree not to donate sperm during that time.
• People who have previously had radiation therapy to the prostate or other sites (external beam or stereotactic), including for pain relief — though people who have had extensive radiation to the spine and central skeleton may need additional review by the trial team.
• People who have previously had brain metastases that have been treated, provided the brain disease has been stable on imaging for at least 28 days before the first dose, they do not need more than a low dose of steroid medication to manage symptoms, and they have no history of cancer spreading to the lining of the brain or spinal cord compression.

Who may not be able to join:

• People whose prostate cancer has certain rare and aggressive cell types, such as small cell, neuroendocrine, sarcomatoid, or spindle cell components, or where cancer from another part of the body has spread to the prostate.
• People who have had an organ transplant in the past (except corneal transplant).
• People who have another active cancer, other than certain low-risk or early-stage skin or bladder cancers — though some people with a past cancer that was treated with curative intent may be considered on a case-by-case basis (confirm with trial site).
• People who have a medical condition that, in the doctor's judgement, would prevent safe or full participation — for example, severe claustrophobia that does not respond to medication, significant back pain that prevents lying on a scan table, or inability to remain still for imaging procedures.
• People who still have significant side effects (grade 2 or higher) from a previous cancer treatment, except for hair loss or mild nerve-related numbness or tingling in the hands or feet.
• People with a history of serious allergic reactions, or who are known or expected to be allergic to protein-based medicines or to the study drug (161Tb-RAD402) or its ingredients.
• People whose blood test results show that key organs are not working well enough, including: kidneys filtering below a certain level, low platelet count, low white blood cell count, low red blood cell count (anaemia), elevated liver enzymes, or abnormal blood clotting results — specific thresholds apply and the trial site can confirm details.
• People who have needed a blood transfusion within 2 weeks before the first planned dose of the study drug.
• People with significant heart problems, including unstable chest pain, a heart attack within the past 6 months, moderate-to-severe heart failure, certain abnormal heart rhythms, reduced heart pumping function (ejection fraction below 50%), or a specific type of abnormal heart electrical signal on an ECG (QTcF above 480 ms or congenital long QT syndrome).
• People who are currently participating in another interventional clinical trial for their cancer.
• People who have had major surgery within 4 weeks before the first planned dose of the study drug.
• People who have previously been treated with a PARP inhibitor (a type of targeted cancer drug) or with radium-223 (Xofigo).
• People who have received any cancer treatment — including chemotherapy, immunotherapy, radiation, biological therapy, herbal cancer therapy, or another investigational treatment — within 28 days (or within 5 half-lives for certain drug types, whichever is shorter) before the first planned dose.
• People with a currently active hepatitis B or hepatitis C infection — some people with a history of hepatitis B or C who have been treated and have very low or undetectable virus levels may be considered on a case-by-case basis (confirm with trial site).
• People with any other serious uncontrolled illness or active infection requiring treatment through the whole body (systemic therapy).
• People with untreated moderate to severe blockage of the tubes connecting the kidneys to the bladder (hydronephrosis) — this may not apply if the blockage has been corrected with a stent or drain.
• People whose bone scan shows a very widespread pattern of bone disease known as a "superscan."
• People with an active autoimmune disease that has required systemic treatment within the past 90 days — note that standard hormone or steroid replacement therapy at low doses is generally not considered systemic treatment for this purpose (confirm with trial site).
• People with any other serious health condition that, in the doctor's judgement, could affect safety, the ability to follow the study plan, or the reliability of the study results.

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