RecruitingPHASE1, PHASE2INTERVENTIONAL

Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer

This study is testing a new treatment combination for men with advanced prostate cancer that has spread to other parts of the body (metastatic) and is no longer responding to standard hormone treatments (castration-resistant). The combination involves two drugs: Gedatolisib and Darolutamide. Darolutamide is already a type of hormone treatment, and Gedatolisib is a new drug that aims to stop cancer growth in a different way. The study has two main parts: first, finding the safest and most effective dose of the drugs when given together, and then, checking how safe and helpful this new combination is for patients. This research is important for finding new ways to treat prostate cancer when current treatments are no longer effective.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Celcuity Inc

Enrolment target

Start

01 Jan 2024

Estimated completion

01 Jan 2030

mCRPC (Metastatic Castration-resistant Prostate Cancer)Genital Diseases, Male Urogenital Diseases, Male Prostatic Disease Prostatic Neoplasms, Castration-Resistant Prostate Cancer

What is this study about?

This research study is for men who have advanced prostate cancer that has spread to other parts of the body. This is called 'metastatic prostate cancer.' Specifically, the study is for men whose cancer has stopped responding to hormone therapy, which is known as 'castration-resistant prostate cancer' (mCRPC). These are cancers that have grown even while the body's testosterone levels are kept very low, either through surgery or medication.

The study is testing a new way to treat this type of cancer by combining two different medications. One of the drugs, Darolutamide, is a common hormone therapy that helps block the effects of male hormones on cancer cells. The other drug, Gedatolisib, is a newer medicine that works in a different way to try and stop cancer cells from growing and dividing. The hope is that by combining these two drugs, they might be more effective together than either drug alone.

The study itself is being done in two main steps. The first step, called Phase 1, involves finding the right dose of these two drugs when given together. The researchers will start with a low dose and gradually increase it in different groups of patients, carefully watching for any side effects. Once a safe and promising dose is found, the second step, Phase 2, will involve more patients taking that dose. In this part, the researchers will look more closely at how well the drug combination works to shrink or stop the cancer, and continue to monitor for any side effects.

Key takeaways

This study is for men with advanced, spreading prostate cancer that no longer responds to standard hormone therapy.
It tests a new drug combination: Gedatolisib and Darolutamide.
The first part of the study finds the best dose; the second part checks how well it works.
Participation involves regular clinic visits, blood tests, and scans.
You get access to a new potential treatment, but there's no guarantee of benefit.
Side effects are possible, and you can leave the study at any time.

Who may be eligible?

This study is specifically for men aged 18 or older who have advanced prostate cancer that has spread and is no longer responding to standard hormone therapy. Your prostate cancer must be confirmed by specific tests.

To be considered for the study, your cancer must have shown signs of getting worse while you were already on a newer type of hormone treatment, like abiraterone, enzalutamide, apalutamide, or darolutamide. This means your cancer has progressed despite receiving one of these treatments.

Doctors will also check your general health and how well you can carry out daily activities. You'll need to have regular scans and blood tests to confirm the cancer's spread and its activity.

Quick self-check

Are you a man aged 18 or older?
Do you have prostate cancer that has spread?
Has your prostate cancer grown even after hormone treatment?
Has your cancer progressed while on a newer type of hormone therapy (e.g., abiraterone, enzalutamide, apalutamide, or darolutamide)?
Are you generally well enough to participate in a study?
Are you able to continue with your current hormone therapy (if you haven't had surgery)?

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 this study, you will be given two drugs: Gedatolisib and Darolutamide. These will likely be given as pills. The study involves regular visits to the clinic for medical check-ups, blood tests, and scans (such as CT, MRI, or bone scans) to monitor your health and how the treatment is affecting your cancer. These tests help doctors understand how safe the treatment is and how well it's working.

Initially, the study will focus on finding the best dose of the drug combination. Once that dose is determined, more patients will receive that specific dose. The total duration of your participation will depend on how you respond to the treatment and the study's specific plan, but you will be monitored closely throughout. There will also be follow-up appointments after you stop taking the study medication.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access new treatments before they are widely available. While there's no guarantee the treatment will work for you, it could potentially help manage your cancer. However, like all medications, Gedatolisib and Darolutamide can have side effects. Doctors will carefully monitor you for these and discuss any concerns. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (13)

Barbara Ann Karmanos Cancer Institute
Detroit, United States· Recruiting
Centre Jean Perrin
Clermont-Ferrand, France· Not yet recruiting
Institut Paoli-Calmettes
Marseille, France· Not yet recruiting
Centre Antoine Lacassagne
Nice, France· Not yet recruiting
Institut Gustave Roussy
Villejuif, France· Not yet recruiting
Hospital Clinic Barcelona
Barcelona, Spain· Recruiting
Institut Catala d'Oncologia
Barcelona, Spain· Recruiting
Hospital General Universitario Gregorio Maranon
Madrid, Spain· Not yet recruiting
Hospital 12 de Octubre
Madrid, Spain· Recruiting
Instituto Valenciano de Oncología
Valencia, Spain· Not yet recruiting
Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospita
Cambridge, United Kingdom· Not yet recruiting
University Hospital Southampton NHS Foundation Trust - Southampton General Hospital
Southampton, United Kingdom· Not yet recruiting

+1 more sites — see the official record for the full list.

Common questions

What does 'metastatic castration-resistant prostate cancer' mean?

It means your prostate cancer has spread to other parts of your body and is growing even though treatments have lowered your testosterone levels (castration).

What are Gedatolisib and Darolutamide?

Darolutamide is a type of hormone treatment used for prostate cancer. Gedatolisib is a newer drug that works in a different way to try and stop cancer growth. This study is testing them together.

What is the main goal of this study?

The main goal is to find the safest and most effective dose of Gedatolisib and Darolutamide together, and to see how well they work against prostate cancer that has spread.

Will I know if I'm getting the active drugs?

Yes, this is an 'open-label' study, which means both you and your doctors will know you are receiving Gedatolisib and Darolutamide.

What if my cancer gets worse during the study?

Your doctors will monitor your cancer closely. If your cancer progresses or if the treatment is no longer beneficial, they will discuss your options, and you may discontinue the study treatment.

How to find out more

Genelle Brower, RN

gbrower@celcuity.com 844-310-3900 Official trial record

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