Health Trials

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 group

Locations

2
Switzerland
Oncolgy Institute of Southern Switzerland (IOSI) Bellinzona Switzerland
United Kingdom
The Royal Marsden NHS Foundation TrustSM2 5PT, Sutton United Kingdom

Sponsors and collaborators

Institute of Cancer Research, United Kingdom

Lead sponsor

Prostate Cancer Foundation

Collaborator

Source ClinicalTrials.gov