RecruitingPhase 1Phase 2NCT06126731

Combination Study of Antibiotics With Enzalutamide (PROMIZE)

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 With Metastatic Castration Resistant Prostate Cancer (mCRPC).

Sponsor

Institute of Cancer Research, United Kingdom

Enrollment

39 participants

Start Date

Nov 2, 2023

Study Type

INTERVENTIONAL

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).

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (PROMIZE) is studying whether combining antibiotics with the hormone-blocking drug enzalutamide can overcome treatment resistance in men with castration-resistant prostate cancer — meaning prostate cancer that keeps growing despite very low testosterone levels. **You may be eligible if:** - You are a man aged 18 or older with metastatic castration-resistant prostate cancer - Your cancer has progressed after at least 12 weeks on a newer hormonal treatment (like enzalutamide, apalutamide, or darolutamide) - You have previously received a taxane chemotherapy (or are not fit/willing to receive one) - Your testosterone remains below 50 ng/dL on androgen deprivation therapy - Your life expectancy is at least 12 weeks - Your blood counts, liver, and kidney function are within acceptable levels **You may NOT be eligible if:** - You have received systemic antibiotics within 12 weeks before the study - You have a history of hearing loss, stroke, epilepsy, or significant heart disease - You have active brain or spinal fluid metastases - You have active hepatitis B, hepatitis C, or HIV - You are allergic to penicillin, amoxicillin, metronidazole, vancomycin, ciprofloxacin, or enzalutamide - You have inflammatory bowel disease or significant gut problems affecting drug absorption Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEnzalutamide 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)

DRUGAmoxicillin 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

DRUGMetronidazole 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

DRUGVancomycin 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

DRUGCiprofloxacin 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

Locations(2)

Oncolgy Institute of Southern Switzerland (IOSI)

Bellinzona, Switzerland

The Royal Marsden NHS Foundation Trust

Sutton, United Kingdom

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NCT06126731