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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Malignant neoplasms of male genital organs
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This is a multi-centre Phase I/II study of the combination of enzalutmide together with the antibiotics amipicillin (or ciprofloxacin), metronidazole, vancomycin and neomycin in patients with metastatic castration resistant prostate cancer.
There is evidence to suggest that modulation of the gut microbiota could help reverse resistance to enzalutamide in patients with metastatic castration resistant prostate cancer. Patients will take ampicillin (or ciprofloxacin in cases of ampicillin intolerance) and metronidazole for two weeks followed by vancomycin and neomycin for two weeks alongside enzalutamide. After this month, patients will continue on enzalutamide until progression. The main aims of this study are therefore to determine the safety profile and tolerability of this combination in the phase I study before the phase II study, in which antitumor activity in mCRPC will be evaluated.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Drug;
You can take part if:
You may not be able to take part if:
1. Surgery, radiotherapy, chemotherapy, or other anti-cancer therapy within 4 weeks prior to trial entry (6 weeks for bicalutamide). Bisphosphonates or RANK ligand inhibitors are permitted in patients with known osteopenia, osteoporosis or bone metastases. Prior antiandrogenic treatment exclusions: • Patients receiving enzalutamide immediately preceding the trial do not require a washout. • Prior flutamide treatment during previous 4 weeks. N.B. Patients without PSA decline in response to antiandrogens given as a second line or later intervention will only need a 14-day washout; • Prior bicalutamide (Casodex) and nilutimide (Nilandron) treatment during previous 6 weeks; • Prior progesterone, medroxyprogesterone, progestins, cyproterone acetate, tamoxifen, and 5-alpha reductase inhibitors during previous 2 weeks (14-days). 2. Ongoing toxic manifestations of previous treatments. Exceptions are alopecia or certain Grade 1 toxicities, which in the opinion of the Investigator and the DDU should not exclude the patient. 3. Previous treatment with any systemic antibiotic within 12 weeks of study entry. 4. Hypersensitivity or intolerance of any of the antibiotics used in this study or enzalutamide. 5. Use of drugs that are prohibited concomitant medications, including strong inducers and inhibitors of CYP450. Seville orange or grapefruit products and any herbal medications should be avoided for 4 weeks prior to starting trial treatment. Concurrent treatment with prohibited medications which include medications that causes ototoxicity, neurotoxicity, and nephrotoxicity. 6. Known brain or leptomeningeal metastases. 7. History of clinically significant hearing loss including but not limited to congenital hearing loss, need for hearing aids, ongoing acute or chronic ear infection, history of tympanic membrane perforation, tinnitus, vertigo, Meniere disease, cerebrovascular ischemia. 8. Patients with partners of child-bearing potential (unless they agree to take measures not to father children by using a barrier method of contraception [condom plus spermicide] or to sexual abstinence effective from the first administration of any of the investigational agents, throughout the trial and for six months afterwards. Patients with partners of child-bearing potential must also be willing to ensure that their partner uses an effective method of contraception for the same duration for example, hormonal contraception, intrauterine device, diaphragm with spermicidal gel or sexual abstinence). Patients with pregnant or lactating partners must be advised to use barrier method contraception (for example, condom plus spermicidal gel) to prevent exposure of the foetus or neonate. 9. Any condition that would increase enteral absorption in the opinion of the investigator including but not limited to malabsorption syndromes, impaired GI motility, chronic pancreatitis, partial or complete gastric and/or bowel resections, history of clinically significant gastrointestinal bleeding in the last 6 months, history of mesenteric ischemia or bowel obstruction, chronic diarrhoea (> = Grade 2), inflammatory bowel disease (Crohn’s disease, ulcerative colitis). 10. At high medical risk because of non-malignant systemic disease including active uncontrolled infection. 11. Clinically significant history of liver disease consistent with Child-Pugh Class B or C, including viral or other hepatitis, current alcohol abuse, or cirrhosis. 12. Serologically positive for hepatitis B, hepatitis C or HIV. 13. Any of the following cardiac criteria: • Clinically important abnormalities including rhythm, conduction or ECG changes (left bundle branch block, third degree heart block). • Factors predisposing to QT prolongation including congenital long QT syndrome; family history of prolonged QT syndrome, unexplained sudden death (under 40); concomitant medications known to prolong QT interval. • Concurrent congestive heart failure, prior history of class III/ IV cardiac disease (New York Heart Association [NYHA], cardiac ischaemia or cardiac arrhythmia. 14. Prior bone marrow transplant or have had extensive radiotherapy to greater than 25% of bone marrow within 8 weeks. 15. Active or uncontrolled autoimmune disease requiring corticosteroid therapy or other forms of systemic immunosuppression. 16. Patient is a participant/plans to participate in another interventional clinical trial, whilst taking part in this study (except observational studies) 17. Any other condition which in the Investigator’s opinion would not make the patient a good candidate for the trial. 18. Malignancy other than prostate cancer within 3 years of trial entry, except adequately treated basal cell carcinoma. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy must have no evidence of that disease for at least 3 years and be deemed eligible. 19. Symptoms of COVID-19 and/or current documented COVID-19 infection.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by Institute of Cancer Research: Royal Cancer Hospital and funded by PROSTATE CANCER FOUNDATION .
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Read full details
for Trial ID: CPMS 51801
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