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 by laboratory testing to have metastatic castration-resistant prostate cancer or a related form that has stopped responding to standard treatment, or for whom no standard treatment is available or who have chosen not to pursue standard treatment.
• People whose prostate cancer has been shown to be getting worse, based on standard measurement tools, in soft tissue, bone, or through rising PSA levels, or through worsening pain requiring radiation treatment to the bones.
• Phase I: People whose cancer progressed after at least 12 weeks on a specific type of hormone-blocking drug (called a NAAT) within the past 6 months. Phase II: People meeting that same recent progression requirement (for the combination treatment arm), or those whose cancer progressed on that drug more than 6 months ago (for a different arm of the trial) (confirm with trial site).
• People who have already received at least one course of a chemotherapy drug called a taxane, or who are considered medically unfit for taxane chemotherapy, or who have chosen not to receive it.
• People who are on ongoing hormone-suppression therapy that keeps their testosterone blood level below a specific low threshold (less than 50 ng/dL or 2.0 nM).
• People with a life expectancy of at least 12 weeks.
• People who are able to swallow tablets.
• People for whom stored tumour tissue samples are available for the research team to analyse.
• People who are willing to have small tumour biopsies taken before and after treatment, if it is safe and practical to do so.
• People with a general health and activity level rated 0, 1, or 2 on the World Health Organisation (WHO) performance scale, meaning they are able to carry out at least some daily activities independently.
• People whose recent blood test results (taken within one week before starting the trial) fall within acceptable ranges for blood cell counts, liver function, kidney function, and protein levels as required by the trial.
• People aged 18 years or older.
• People who have read, understood, and signed a consent form, and who are able to cooperate with treatment and follow-up appointments.
• People who are willing and able to provide blood, urine, tumour biopsy, rectal swab, and stool samples as required by the study.

Who may not be able to join:

• People who have had surgery, radiotherapy, chemotherapy, or other cancer treatments within 4 weeks before joining the trial (or within 6 weeks for a specific drug called bicalutamide), with some specific exceptions around certain hormone-blocking drugs and bone-protecting medications (confirm timing details with trial site).
• People who are still experiencing significant harmful side effects from previous cancer treatments, with some minor exceptions for hair loss or mild side effects considered acceptable by the investigator.
• People who have taken any antibiotic medication in the 12 weeks before joining the trial.
• People who have a known allergy or serious sensitivity to any of the following medications: penicillin, amoxicillin, metronidazole, vancomycin, ciprofloxacin, or enzalutamide.
• People with a history of tendon problems caused by a class of antibiotics called quinolones.
• People taking certain medications that are not permitted during the trial, including strong drugs that affect how the body processes other medications, or products such as Seville orange, grapefruit, or herbal supplements.
• People taking medications known to cause damage to hearing, nerves, or kidneys.
• People with known or suspected cancer that has spread to the lining of the brain or spinal cord, or with untreated brain metastases. People with previously treated brain metastases that have been stable for more than 6 months may be considered (confirm with trial site).
• People with a history of stroke or epilepsy, current excessive alcohol use, or a clinically significant history of hearing problems including congenital hearing loss, use of hearing aids, active or ongoing ear infections, perforated eardrum, tinnitus, vertigo, Meniere's disease, or reduced blood flow to the brain.
• People whose partners are capable of becoming pregnant, unless both the participant and their partner agree to use effective contraception throughout the trial and for 6 months after it ends. People with pregnant or breastfeeding partners must use barrier contraception to protect the baby from exposure to the trial drugs.
• People with certain digestive or gastrointestinal conditions that could affect how the body absorbs medication, including conditions such as inflammatory bowel disease, chronic diarrhoea, a history of significant gastrointestinal bleeding in the past 6 months, or previous removal of parts of the stomach or bowel.
• People who are at high medical risk due to serious non-cancer illness, including active infections that are not under control.
• People with a significant history of liver disease, including certain liver conditions, active alcohol misuse, or cirrhosis.
• People who have tested positive for hepatitis B, hepatitis C, or HIV.
• People with certain heart conditions, including serious heart rhythm or electrical problems, a history of heart failure, a history of reduced blood supply to the heart, a history of heart arrhythmia, a family or personal history of prolonged QT syndrome, or a specific heart measurement (QTcF) of 460 ms or above on an ECG.
• People who have had a bone marrow transplant, or who have had extensive radiation to a large portion of their bone marrow within the past 8 weeks.
• People with an active or poorly controlled autoimmune disease that requires steroid or other immune-suppressing treatment.
• People who are already participating in another interventional clinical trial or plan to do so during this study. Participation in an observational study (where no treatment is given) would be acceptable.
• People with any other condition that, in the investigator's opinion, would make them unsuitable for this trial.
• People who have had another type of cancer within the 3 years before joining the trial, with the exception of a fully treated skin cancer (basal cell carcinoma). People who completed curative treatment for a prior cancer and have had no signs of that cancer for at least 3 years may be considered eligible (confirm with trial site).
• People who currently have symptoms of COVID-19 or a confirmed active COVID-19 infection.

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