MedTrace Logo

Combination Study of Antibiotics With Enzalutamide (PROMIZE)

NCT06126731 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2025-11-24

No results posted yet for this study

Summary

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).

Conditions

  • Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Interventions

DRUG

Enzalutamide 40mg

Enzalutamide is presented in 40mg yellow film-coated tablets. They are supplied in a cardboard wallet incorporated a PVC/PCTFE/aluminium blister pack which holds 28 tablets. Each carton contains 4 wallets (112 tablets in total)

DRUG

Amoxicillin 500mg

Red / Buff coloured size '0' capsules containing white to off white powder printed with 'AMOXY 500 ' in black ink OR White to off-white granular powder filled in hard gelatine capsule shells size '0'. Scarlet colour cap, buff colour body printed with 'AMOXY' on cap and '500' on body OR White/Maroon size '0' capsules containing white to yellowish granular powder

DRUG

Metronidazole 400mg

Yellow, circular (11mm), biconvex, film-coated tablets with '400' debossed on one side and plain on other side OR White to off white coloured, caplet shaped (17.00 x 6.00 mm) film-coated tablets, debossed "400" on one side and plain on other side OR Off-white coloured, round, biconvex uncoated tablets engraved "MZ 400" \& break line on one side and plain on other

DRUG

Vancomycin 125mg

Grey/pink 17.8 ± 0.40 mm hard capsules each containing 125mg, containing white to off white congealed liquid mixture as solid mass OR Dark blue and brown hard capsules, imprinted with 3125 in red ink OR Brown 21.4 ± 0.40 mm hard capsule, containing white to off white congealed liquid mixture as solid mass

DRUG

Ciprofloxacin 500g

White to off white, capsule shaped, film coated tablets, with a score line on one side and debossed with 'F22' on the other side. The tablet can be divided into equal doses. The size is 18.2 mm x 8.1 mm OR White, caplet shaped film-coated tablets debossed with '500' on one side and plain on the other side OR White to off-white, capsule shape, biconvex with bevelled edge, film coated tablet with inscription 'CI' on one side and plain on the other side OR White, oval shaped film-coated tablets debossed 'C500' on one side and breakline on other side

Sponsors & Collaborators

  • Prostate Cancer Foundation

    collaborator OTHER

  • Institute of Cancer Research, United Kingdom

    lead OTHER

Principal Investigators

  • Johann De Bono, MD · National Health Service, United Kingdom

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-02
Primary Completion
2026-06-30
Completion
2027-06-30

Countries

  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06126731 on ClinicalTrials.gov