PROMIZE
Research type
Research Study
Full title
PROMIZE: A Phase I/II Trial to Assess the Safety, Tolerability and Preliminary Anti-tumour Activity of Oral Combination antibiotic therapy to modulate the microbiome in combination with enzalutamide in metastatic castration resistant prostate cancer (mCRPC)
IRAS ID
302666
Contact name
Johann De Bono
Contact email
Sponsor organisation
The Institute of Cancer Research
Eudract number
2021-004559-18
Duration of Study in the UK
3 years, 0 months, 4 days
Research summary
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.
REC name
London - City & East Research Ethics Committee
REC reference
22/LO/0070
Date of REC Opinion
14 Mar 2022
REC opinion
Further Information Favourable Opinion