Combination Study of Antibiotics With Enzalutamide (PROMIZE)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorInstitute of Cancer Research, United Kingdom
About this trial
PROMIZE is an open-label, multi-centre, single-arm, Phase I/II clinical trial, evaluating the safety, tolerability and anti-tumuor efficacy of an antibiotic combination and enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC).
Eligibility criteria
Qualifiers
Histologically or cytologically proven metastatic castration-resistant prostate cancer or adenocarcinoma refractory to conventional treatment, or for which no conventional therapy exists or is declined by the patient.
Progression of soft tissue/visceral disease by RECIST (v1.1) and/or,
Progression of bone disease by PCWG3 bone scan criteria and/or,
Progression of PSA by PCWG3 PSA criteria and/or
Disqualifiers
Patients receiving enzalutamide immediately preceding the trial will be able to continue on enzalutamide without washout.
Prior flutamide treatment during previous 4-weeks. N.B. Patients whose PSA did not decline in response to antiandrogens given as a second line or later intervention will only require 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).
Trial design
Treatments tested in this trial
- Enzalutamide 40mg
- Amoxicillin 500mg
- Metronidazole 400mg
- Vancomycin 125mg
- Ciprofloxacin 500g
Treatment groups
39 Participants
are divided into 1 treatment groupSponsors and collaborators
Institute of Cancer Research, United Kingdom
Lead sponsor
Prostate Cancer Foundation
Collaborator
Source ClinicalTrials.gov