Phase 2 Prostate Cancer Trial, Recruiting

Written by an AI model from the 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 been confirmed (through a tissue or cell sample) to have prostate cancer, either from a new biopsy or stored tissue.
• People aged 18 years or older.
• People whose prostate cancer has spread to other parts of the body (metastatic), is no longer responding to hormone-lowering treatments (castration-resistant), and has continued to grow based on specific medical assessment guidelines.
• People whose cancer is a specific type called adenocarcinoma.
• People who have previously been treated with at least one newer type of hormone-blocking medication, such as abiraterone acetate, enzalutamide, apalutamide, or darolutamide.
• People who have had surgical removal of the testicles and/or are currently on hormone-suppressing therapy, with testosterone levels confirmed to be very low (below 50 ng/dL or 1.7 nmol/L).
• People who have had a specific type of scan (68Ga-PSMA-11 PET scan) showing at least one area in the body that has tested positive for a particular protein marker (PSMA-positive), as confirmed by a nuclear medicine specialist before starting the trial medication.
• People whose general health and ability to carry out daily activities falls within a certain range, as measured by a standard medical scale (ECOG performance status 0–2).
• People who are expected to live for more than 6 months.
• People whose blood counts, liver function, and kidney function meet specific levels required for safe participation (confirm with trial site for exact values).
• People who are able to swallow tablets or capsules by mouth.
• People who are able to understand and are willing to sign a written consent form.
• People living with HIV who are on effective treatment and have had an undetectable level of virus in their blood within the past 6 months.
• People with a long-term hepatitis B infection who are on appropriate treatment and have an undetectable level of the virus in their blood.
• People who previously had hepatitis C and have been successfully treated and cured, or who are currently being treated for hepatitis C with an undetectable virus level.
• People who have or have had another type of cancer, as long as that cancer or its treatment is not expected to interfere with the safety or results of this trial.
• People with the potential to father children who agree to use effective contraception and not donate sperm during the study and for at least 2 months after the last dose of study treatment.

Who may not be able to join:

• People whose prostate cancer is a type called small cell or neuroendocrine carcinoma.
• People whose bone scan shows a pattern of very widespread cancer activity throughout the skeleton (known as a "super scan").
• People who have previously been treated with a type of medication called CDK4/6 inhibitors.
• People who have previously received a PSMA-targeted radioligand therapy (a radiation-based treatment that targets the PSMA protein).
• People who have received a medication called Radium-223 within 6 weeks before joining the trial.
• People who have received any systemic cancer treatment within 3 weeks before joining the trial.
• People who experienced serious (grade 3 or higher) side effects from previous radiation treatment, or whose radiation-related side effects have not yet resolved.
• People with cancer that has spread to the brain or spinal cord area, unless they have already been treated for it, are not experiencing symptoms, and are not taking steroid medications for that condition.
• People who are currently experiencing symptoms of pressure on the spinal cord, or are at risk of it.
• People with other serious medical conditions, as assessed by the lead doctor running the trial.
• People with another active cancer that is likely to affect life expectancy or make it difficult to assess the prostate cancer during the trial (some exceptions apply — confirm with trial site).
• People who have not yet recovered from serious side effects (above a mild level) caused by previous cancer treatments, not including hair loss or nerve-related numbness/tingling.
• People with serious or uncontrolled ongoing health conditions that the trial doctor believes would make participation unsafe, such as certain lung conditions, severe breathing difficulties, major stomach or bowel surgery history, or ongoing bowel diseases like Crohn's disease or ulcerative colitis.
• People with an active serious infection (such as a bacterial infection requiring IV antibiotics, a fungal infection, or an active and detectable viral infection including active hepatitis B or C).
• People who have a personal history of fainting due to a heart-related cause, dangerous irregular heart rhythms (such as ventricular tachycardia or fibrillation), or sudden cardiac arrest.
• People who are currently taking part in another clinical trial involving an experimental treatment.

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