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:

• Adults aged 18 or older who are willing and able to sign a consent form
• People with a life expectancy of at least 3 months
• People who are willing to have a biopsy (a small tissue sample taken for testing)
• People who are well enough to carry out basic daily activities without significant limitation (confirm with trial site what level of functioning is required)
• People whose blood counts and organ function — including white blood cells, red blood cells, platelets, liver, kidneys, and blood clotting — meet minimum health thresholds set by the trial (confirm specific values with trial site)
• People who have measurable tumour(s) visible on a CT scan
• Women who are not pregnant, not breastfeeding, and either cannot become pregnant or agree to use contraception during treatment and for at least 4 weeks after the last dose, with a negative pregnancy test before starting
• Men who agree to use contraception during treatment and for at least 4 weeks after the last dose
• People who are willing and able to follow all study procedures

For Module 1 (single drug treatment):

• People with an advanced or metastatic solid tumour (cancer that has spread) for which no standard or effective treatments are available
• People whose cancer shows signs of specific DNA repair defects (called Homologous Recombination or Fanconi Anaemia defects), confirmed by an approved genetic test from a certified laboratory — OR people with cancer types known to commonly have these defects (such as ovarian, breast, pancreatic, prostate, or head and neck cancers) — OR people whose cancer previously responded to a type of chemotherapy called alkylating agents

For Module 2 (combination with carboplatin chemotherapy):

• People with an advanced or metastatic solid tumour for which no standard or effective treatments are available, and for whom carboplatin chemotherapy is considered appropriate by the treating doctor
• People with triple negative breast cancer or ovarian cancer who are receiving carboplatin as their standard treatment

For Module 3 (combination with immune checkpoint inhibitor therapy):

• People with an advanced or metastatic solid tumour
• People who have been receiving a type of immunotherapy called an immune checkpoint inhibitor as their standard treatment for at least 6 months, and whose cancer has shown limited, localised progression (growth in only one or two specific areas) while on that treatment

Who may not be able to join:

• People who have had radiation to more than 25% of their bone marrow
• People who have not yet recovered from significant side effects of previous cancer treatment
• People with serious heart conditions, including severe heart failure, unstable chest pain, a heart attack within the past 6 months, dangerous irregular heartbeats, or certain other heart-related conditions
• People with a significantly abnormal heart rhythm reading on an ECG (electrocardiogram) (confirm with trial site)
• People with a personal or family history of certain heart rhythm problems, or conditions such as low potassium levels that increase the risk of a specific abnormal heart rhythm
• People currently taking medications known to affect heart rhythm in a specific way (confirm with trial site)
• People with an active, uncontrolled infection currently requiring intravenous antibiotics
• People with any other serious health condition or abnormal test result that the trial doctor believes could put them at risk
• People diagnosed with certain rare inherited genetic disorders affecting DNA repair, such as Fanconi anaemia, Ataxia telangiectasia, or similar conditions
• People who are planning to receive other cancer treatments — including chemotherapy, radiation, hormone therapy, or immunotherapy — at the same time as the trial treatment
• People who have taken part in another clinical trial drug or device study within the past 30 days (or 60 days for biological treatments)
• People who had major surgery less than 4 weeks before starting the trial
• People known to be living with HIV, or who have active Hepatitis B or Hepatitis C with abnormal liver function
• People with a known allergy to alkylating agents (a type of chemotherapy)
• People with cancer that has spread to the brain or spinal fluid, with the exception of people whose brain metastases are stable, causing no symptoms, and have not required steroid medication for at least 14 days — people with cancer in the membranes around the brain or spinal cord are not eligible regardless of symptoms
• People who have had another invasive cancer within the past 3 years, with some specific exceptions (such as certain treated skin cancers, treated in-situ cancers, or low-risk early-stage prostate cancer — confirm with trial site)
• People with an autoimmune disease that required systemic (whole-body) treatment within the past 2 years
• People diagnosed with an immune deficiency condition, or who are taking high-dose steroid or other immune-suppressing medications within 7 days before joining (some low-dose or localised steroid uses may be permitted — confirm with trial site)
• People who have received a live vaccine within the past 30 days
• People who have had a bone marrow or organ transplant
• People with current lung inflammation (pneumonitis), or a history of non-infectious lung inflammation that required steroids or immune-suppressing treatment
• People who have had uncontrolled fluid build-up in the abdomen, lungs, or around the heart within the past 6 months
• People who have had a bowel obstruction requiring surgery, serious bowel inflammation, or an abdominal abscess within the past 6 months
• People who have had allergy desensitisation treatment within the past 4 weeks
• People with serious liver disease, including cirrhosis with complications such as fluid build-up, confusion, or jaundice (some stable liver conditions may be acceptable — confirm with trial site)
• People with a known history of active tuberculosis
• People with a psychiatric or other condition that, in the trial doctor's view, could affect their safety, their ability to consent, or their ability to follow study procedures

For Module 1 (single drug treatment):

• People who have received any cancer treatment (including radiation) within the past 4 weeks

For Module 2 (combination with carboplatin):

• People who have received any cancer treatment other than carboplatin within the past 4 weeks

For Module 3 (combination with immune checkpoint inhibitor therapy):

• People who have received any cancer treatment other than their immune checkpoint inhibitor within the past 4 weeks
• People whose cancer is progressing so rapidly that the treating doctor determines the immune checkpoint inhibitor must be stopped immediately
• People who would not otherwise continue to receive immune checkpoint inhibitor treatment as their standard care
• People whose cancer has had a complete response (full disappearance of detectable cancer) while on immune checkpoint inhibitor treatment

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