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 diagnosed with prostate cancer (a type called adenocarcinoma) confirmed by a tissue or cell sample, with cancer that has spread to other parts of the body (such as bones or soft tissue).
• People who have had scans to assess all areas of disease (including a bone scan or PET scan) within the 6 weeks before joining the trial.
• People who have been on hormone-suppressing treatment (medical injections or surgical removal of the testicles) for no more than 42 days before starting the trial medication, abiraterone.
• People who previously received hormone-suppressing treatment before or after surgery for prostate cancer (not for metastatic disease), as long as it lasted no more than 36 months, ended at least 6 months ago, and testosterone levels have returned to normal range.
• People who have high-risk or extensive hormone-sensitive metastatic prostate cancer, as judged by their treating doctor, and who are either not suitable for a chemotherapy called docetaxel or have chosen not to receive it.
• People who have had surgery in the past, provided at least 14 days have passed since the operation and they have recovered from major side effects, as assessed by the investigator.
• People who are receiving or plan to receive bone-protecting medications (such as denosumab or bisphosphonates) that do not affect PSA levels.
• People who have no plans to participate in any other experimental treatment while on this trial, and whose last experimental treatment finished at least 28 days before joining.
• People who have had a full physical examination and medical history review within 28 days before joining.
• People with a PSA level of 10 ng/mL or higher, measured within 90 days before joining.
• People with a normal heart electrical reading (ECG) showing a QTc interval below 461 milliseconds, measured within 42 days before joining (confirm with trial site if heart conduction abnormalities are present).
• People with adequate liver function, confirmed by blood tests within 28 days before joining.
• People with adequate kidney function, confirmed by blood or urine tests within 28 days before joining.
• People with adequate blood cell counts (white blood cells, red blood cells, and platelets) within 28 days before joining.
• People with a general health and activity level rated 0–2 on the Zubrod scale, or rated 3 only if the limitation is due to bone pain.
• People who have had certain other past cancers may still be eligible: adequately treated skin cancers, early-stage cancers now in full remission, or any cancer from which the person has been disease-free for at least 5 years.
• People aged 18 years or older.
• People (or their legal representative) who are willing to sign an informed consent form agreeing to take part in the study.

Who may not be able to join:

• People with known cancer that has spread to the brain. If brain imaging has been done for any reason, results must show no evidence of cancer there.
• People who have previously received, or are planning to receive, certain hormone-related medications including ketoconazole, aminoglutethimide, or enzalutamide alongside this trial treatment.
• People who have previously received chemotherapy drugs for metastatic prostate cancer. (Chemotherapy given earlier with the aim of curing the cancer — before or after surgery — may be acceptable if it ended at least 2 years ago.)
• People with serious heart conditions, including severe heart failure (Class III or IV), or those who have had a blood clot, unstable chest pain, heart attack, or serious uncontrolled irregular heartbeat within the 6 months before joining.
• People with a known history of adrenal gland insufficiency (primary or secondary).
• People with a known allergy or sensitivity to abiraterone or to the hormone-suppressing injections used in the trial.
• People with known digestive system conditions or who have had digestive procedures that could affect how the body absorbs abiraterone, including difficulty swallowing tablets, as judged by the investigator.

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