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 have been diagnosed with prostate adenocarcinoma (a specific type of prostate cancer), confirmed by a laboratory test on a tissue or cell sample
• People whose prostate cancer has spread to other parts of the body, such as soft tissue or bones
• People who have had imaging scans done within 42 days before or 14 days after starting hormone-blocking treatment (called LHRH therapy)
• People who have already started LHRH hormone-blocking therapy for metastatic prostate cancer, as long as it began no more than 60 days before joining the trial
• People who previously received short-term hormone therapy alongside earlier prostate cancer treatment, provided at least 12 months have passed since the last injection and testosterone levels are above a certain level (confirm with trial site)
• People with a Karnofsky performance status score between 60 and 100, which means they are able to carry out at least some daily activities with some assistance (confirm with trial site)
• Men who are able to father children, including those who have had a vasectomy, who agree to use effective barrier contraception or abstain from sex during treatment and for at least 4 months after treatment ends
• People whose recent blood test results (taken within 28 days before joining) show that the liver, kidneys, and blood cells are functioning within acceptable ranges for the trial
• People who are able to understand and willing to sign a written consent form
• People who previously received hormone-suppressing therapy (ADT) alongside earlier prostate cancer treatment, provided it lasted no more than 36 months in total and ended at least 6 months before joining, with testosterone levels above a certain threshold (confirm with trial site)
• People who have had radiation therapy to relieve pain from bone or organ spread, provided they have fully recovered from side effects by the time of joining
• People who have had prior surgery, provided at least 14 days have passed and they have recovered from the major side effects
• People who are receiving or plan to receive bone-protecting medications (such as denosumab or bisphosphonates) that do not affect PSA levels

Who may not be able to join:

• People who have received, or plan to receive, certain hormone-related medications such as ketoconazole, aminoglutethimide, or enzalutamide alongside the trial treatment (a medication called megestrol for hot flashes is permitted)
• People who have received chemotherapy for metastatic prostate cancer (prior chemotherapy given with the aim of curing earlier-stage prostate cancer may be considered, provided at least 2 years have passed — confirm with trial site)
• People who have cancer that has spread to the brain
• People with serious heart failure (classified as New York Heart Association class III or IV), or who have had a blood clot, unstable chest pain, a heart attack, or a serious uncontrolled heart rhythm problem within the past 6 months
• People with high blood pressure that remains above certain levels (above 160/90 mmHg on two separate readings within one hour) despite appropriate medication — though rescreening may be possible after medication adjustment (confirm with trial site)
• People known to have HIV infection, active hepatitis B or C, a life-threatening illness unrelated to cancer, or a serious medical or psychiatric condition that could affect participation
• People with a known history of adrenal gland insufficiency (either primary or secondary)
• People who have had a significant allergic reaction to medications that are chemically similar to the study drugs
• People who are currently taking part in another clinical trial or receiving other experimental, biological, chemotherapy, or radiation treatments (any previous experimental treatment must have been completed at least 28 days before joining)
• People with known digestive system conditions or who have had a digestive procedure that could affect how the body absorbs the study medications, including people who have difficulty swallowing tablets or capsules
• People with a history of another cancer, except for: adequately treated skin cancers, a stage I or II cancer that is currently in full remission, or any other cancer from which there has been no sign of disease for at least 5 years

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