Combination Study of Antibiotics With Enzalutamide (PROMIZE)

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

November 2, 2023

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2027

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"

Trial Locations (2)

Unknown

RECRUITING

Oncolgy Institute of Southern Switzerland (IOSI), Bellinzona

SM2 5PT

ACTIVE_NOT_RECRUITING

The Royal Marsden NHS Foundation Trust, Sutton

All Listed Sponsors
collaborator

Prostate Cancer Foundation

OTHER

lead

Institute of Cancer Research, United Kingdom

OTHER