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 given written consent before any study procedures begin (consent can be done remotely)
• People who agree to have tissue samples collected at specific points during the study
• Males aged 18 years or older
• People with prostate cancer that has been confirmed by laboratory testing of a tissue or cell sample
• People whose prostate cancer is localised or has spread to nearby lymph nodes, and is considered high-risk based on at least one of the following: a PSA blood test result above 20 ng/mL, cancer that has grown beyond the prostate in a specific way (T3a or higher), a Gleason score of 8 or above (grade group 4–5), or cancer found in nearby lymph nodes
• People who are planned to receive radiation therapy and hormone therapy (to lower testosterone) as their main treatment for prostate cancer
• People who are willing to have ongoing medical treatment to keep testosterone levels very low, or who have already had both testicles surgically removed
• People who are generally well enough to carry out daily activities with minimal limitation (ECOG performance status of 2 or less)
• People whose blood and organ function test results, taken within 7 days before joining, meet all of the following: haemoglobin at least 10.0 g/dL; neutrophil count at least 1.5 x 10⁹/L; white blood cell count above 3 x 10⁹/L; no signs of certain blood disorders (MDS/AML) on a blood test; platelet count at least 100 x 10⁹/L; bilirubin (a liver marker) within acceptable limits (with a special rule applying for people with Gilbert's disease); liver enzyme levels (AST and ALT) within acceptable limits; kidney function (creatinine clearance) of at least 30 mL/min; blood albumin level of at least 3.0; and potassium level of at least 3.5 mmol/L
• People who are able to swallow tablets or capsules whole
• People with a partner who could become pregnant must be willing to use two methods of contraception, including a reliable barrier method, during the study and for 4 months after the last dose of study medication, and must not donate sperm during this time
• People who are willing and able to attend all required visits and follow all study procedures for the full duration of the trial
• People who are able to stop taking any medications known to lower the seizure threshold at least 4 weeks before joining the study (or switch to a different medication)

Who may not be able to join:

• People who have had any prior systemic (whole-body) treatment for prostate cancer, except for hormone therapy (ADT) started within the 6 months before joining; or anyone who has previously received a PARP inhibitor therapy
• People whose prostate cancer has spread to distant parts of the body (distant metastases)
• People who have already had surgery to remove the prostate (prostatectomy) or radiotherapy to treat their prostate cancer
• People who still have significant side effects (grade 2 or higher) from previous cancer treatments that have not resolved
• People with a history or current diagnosis of certain blood disorders (MDS or AML), or a history of another cancer (other than the prostate cancer being treated) that has a 30% or greater chance of coming back within 24 months — with some exceptions for certain minor or fully treated skin or cervical cancers
• People with an active infection that is not under control (though those who have completed a course of antibiotics or antiviral treatment and whose infection is considered controlled may be considered, after discussion with the lead investigator)
• People with active or symptomatic viral hepatitis or ongoing chronic liver disease
• People with active inflammation of the lungs or widespread lung disease unrelated to cancer
• People with any underlying medical or mental health condition that, in the investigator's opinion, would make taking the study drugs unsafe or make it difficult to assess side effects — examples include uncontrolled seizures, a history of organ transplant, or a psychiatric condition that prevents giving informed consent
• People who are unable to swallow oral medication, or who have digestive conditions likely to affect how the study drugs are absorbed
• People with a known allergic reaction to any of the study drugs (niraparib, apalutamide, or abiraterone acetate)
• People who are in prison or are involuntarily held in a detention facility
• People who are being detained under a legal order for treatment of a psychiatric or physical illness
• People with a history of seizures, or conditions that may increase the risk of seizures — such as a stroke within the past year, a brain blood vessel abnormality, or certain benign brain or nervous system conditions that may need surgery or radiation
• People who have had serious heart or blood vessel problems in the 6 months before joining, including severe chest pain (unstable angina), a heart attack, significant heart failure, a blood clot (such as a pulmonary embolism or stroke, including mini-strokes), uncontrolled high blood pressure, or significant heart rhythm problems
• People with any of the following current conditions: a digestive disorder that affects how medication is absorbed; an active uncontrolled infection such as HIV or viral hepatitis; a chronic medical condition requiring more than 10 mg of prednisone or prednisolone daily; a need for certain medications that interact with the study drugs (confirm with trial site); moderate or severe liver impairment (Child-Pugh class B or C); or any other condition that, in the investigator's opinion, would prevent safe participation in the study

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