RecruitingPHASE1, PHASE2INTERVENTIONAL

Combination Study of Antibiotics With Enzalutamide (PROMIZE)

The PROMIZE study is investigating a new treatment strategy for men with prostate cancer that has spread and become resistant to standard hormone treatment. This type of cancer is called metastatic castration-resistant prostate cancer (mCRPC). The study combines a well-known prostate cancer drug, enzalutamide, with a specific course of different antibiotics. The main goals are to find out if this combination is safe, how well people tolerate it, and if it can help slow down or stop the cancer from growing. This is an early-stage study, meaning it's one of the first times this specific combination is being tested in people. It's hoped that this new approach could offer a valuable treatment option in the future for men with this advanced form of prostate cancer.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Institute of Cancer Research, United Kingdom

Enrolment target

Start

02 Nov 2023

Estimated completion

30 Jun 2027

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

What is this study about?

The PROMIZE study is focused on a type of prostate cancer that has spread to other parts of the body (metastatic) and is no longer controlled by standard hormone therapy (castration-resistant). This is a challenging form of cancer to treat, and researchers are constantly looking for new and more effective ways to help patients.

This study is exploring a new idea: combining an existing prostate cancer drug called enzalutamide with a specific combination of antibiotics. Enzalutamide is already approved for treating prostate cancer. The researchers want to see if adding certain antibiotics might make enzalutamide work even better or in a new way. They're particularly interested in understanding if this combination is well-tolerated and safe for patients, and whether it can help shrink tumours or stop them from growing.

The study is split into two main parts (Phase I and Phase II). Phase I is designed to carefully check the safety and side effects of the treatment, making sure the combination of drugs doesn't cause unexpected problems. Once a safe dose and schedule are found, Phase II will then look at how effective the treatment is in a larger group of patients. This research is important because it could potentially offer a new treatment option for men with advanced prostate cancer who have limited choices.

Key takeaways

Investigates a new combination treatment for advanced prostate cancer.
Combines enzalutamide (a standard prostate cancer drug) with antibiotics.
Aims to check safety, tolerability, and effectiveness.
Designed for men whose prostate cancer has spread and resists hormone therapy.
Involves regular medication, clinic visits, and monitoring.
Participation is voluntary, with no guaranteed personal benefit, and side effects are possible.

Who may be eligible?

This study is looking for men who have prostate cancer that has spread to other parts of the body and is no longer responding to standard hormone therapy. You would typically have already received other treatments, such as chemotherapy, or be unable to have them. Your doctors would have confirmed your prostate cancer is growing despite previous treatments.

To be considered, your overall health should be generally good, and you should be able to manage daily activities. You'll need to have certain blood test results within a healthy range, and your testosterone levels must remain low due to ongoing hormone therapy. You should also be able to swallow tablets. The study requires that researchers can access a sample of your tumour tissue, either existing or from a new biopsy if possible.

Some things that might prevent you from joining include not having had prostate cancer progression, other specific medical conditions, or being on certain medications that could interfere with the study drugs. The research team will carefully review all your medical information to determine if this study is suitable for you.

Quick self-check

Do you have prostate cancer that has spread?
Is your prostate cancer no longer responding to hormone therapy?
Have you had previous treatments like chemotherapy, or are you unable to have them?
Are you able to swallow tablets?
Is your general health good enough for you to participate in a clinical trial?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in the PROMIZE study, you will first undergo a series of assessments, including physical exams, blood tests, and scans, to confirm your eligibility. Once enrolled, you will take enzalutamide tablets every day. For the first two cycles (each lasting 4 weeks), you will also take two different combinations of antibiotics. Specifically, you'll take amoxicillin and metronidazole for 2 weeks, followed by ciprofloxacin and vancomycin for another 2 weeks. This antibiotic cycle will then repeat for a second time, meaning you'll take antibiotics for a total of 8 weeks.

After these 8 weeks of combination treatment, you will continue to take enzalutamide daily for as long as it is helping you and you are tolerating it well. Throughout the study, you will have regular clinic visits, blood tests, and scans to monitor your health, how you are tolerating the treatment, and if the cancer is responding. The duration of your participation will depend on how you respond to the treatment, but it could continue until your cancer progresses or if you experience side effects that make it necessary to stop. There will also be follow-up appointments after you stop treatment.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as access to a new treatment combination that is not yet widely available and close medical monitoring. While the main goal of the study is to find out if this combination is safe and effective, there is no guarantee that it will benefit you personally. Like all medicines, enzalutamide and the antibiotics can cause side effects. These could range from mild, like feeling tired or an upset stomach, to more serious issues. The research team will closely monitor you for any side effects and will explain all known risks and potential side effects in detail before you decide to join. Remember, taking part in any clinical trial is entirely voluntary, and you have the right to withdraw at any time, for any reason, without it affecting your future medical care.

Locations (2)

Oncolgy Institute of Southern Switzerland (IOSI)
Bellinzona, Switzerland· Recruiting
The Royal Marsden NHS Foundation Trust
Sutton, United Kingdom· Recruiting

Common questions

What type of cancer is this study for?

This study is for men with advanced prostate cancer that has spread and is no longer responding to standard hormone therapy.

What drugs are being tested?

The study is testing a combination of an existing prostate cancer drug called enzalutamide with several different antibiotics.

Is this a new treatment?

Yes, while enzalutamide is an approved drug, this specific combination with antibiotics is a new approach being investigated in a clinical trial.

What does 'Phase I/II' mean?

Phase I is about checking the safety and side effects, and Phase II is about seeing how effective the treatment is once a safe dose is found.

Can women participate in this study?

No, this study is recruiting only male patients as it focuses on prostate cancer.

How to find out more

PROMIZE Team

PROMIZE@icr.ac.uk 02087224497 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.