Study of Gedatolisib and Darolutamide Combination Treatment for Patients with Metastatic Castration-Resistant Prostate Cancer

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What is this study about?

This study focuses on patients with metastatic castration-resistant prostate cancer (mCRPC), a condition where prostate cancer has spread to other parts of the body and continues to progress despite treatments that lower testosterone levels. The study will test a combination of two medications: gedatolisib (also known as PF-05212384) and darolutamide (BAY 1841788). Dexamethasone will also be used as a supportive medication during the treatment.

The purpose of this research is to determine the safety and effectiveness of combining gedatolisib with darolutamide in treating metastatic castration-resistant prostate cancer. The study is divided into two parts. The first part will focus on finding the right dose of the medications, while the second part will evaluate how well the treatment works in stopping cancer progression.

During the study, participants will receive gedatolisib through infusion (delivery of medication through a vein) and darolutamide as tablets taken by mouth. The treatment will be monitored using various medical tests, including computed tomography (detailed body scans), magnetic resonance imaging (detailed pictures of body structures), and bone scans to check how the cancer responds to treatment.

1 Initial treatment phase

You will receive a combination of three medications:

– Darolutamide tablets taken by mouth

– Gedatolisib given through an infusion (delivered directly into your bloodstream)

– Dexamethasone 2 mg soluble tablets taken by mouth

2 Regular monitoring

Your condition will be monitored through:

– Regular body scans (CT or MRI) to check how the cancer responds to treatment

– Blood tests to check your body’s response to the medications

– Regular health assessments to monitor any side effects

3 Progress evaluation

Your progress will be evaluated by checking:

– Changes in tumor size through body scans

– PSA levels (prostate-specific antigen) in your blood

– Any new areas where cancer might have spread

The evaluation will continue for up to 24 months

4 Follow-up period

After completing the active treatment phase:

– You will need to continue using birth control for at least 12 weeks after the last treatment

– Your health will be monitored to check for any delayed effects

– Regular check-ups will continue to track your overall progress

Who Can Join the Study?

Must be an adult male aged 18 years or older
Must have confirmed prostate cancer (adenocarcinoma type) with less than 10% neuroendocrine cells
Must have cancer that has spread (metastatic) and is resistant to hormone therapy treatments
Must have visible cancer spread on standard imaging tests (CT scan, MRI, or bone scan)
Must show disease progression through one of these ways:
– Rising PSA levels (prostate-specific antigen) in at least 2 tests
– Growth of existing tumors
– New bone lesions appearing on scans
Must be on ongoing hormone therapy (unless previously had surgical removal of testicles)
Must have good physical function (ECOG score of 0 or 1, meaning able to perform daily activities)
Must have a life expectancy of at least 3 months
Must have previously received and shown progression on hormone therapy for metastatic disease
Must wait at least 4 weeks after previous hormone therapy before starting the study
Must have adequate bone marrow, liver, kidney, and blood clotting function
Must be willing to follow study requirements, including scheduled visits and tests
Must agree to use contraception during treatment and for 12 weeks after the last dose
Must be able to understand and sign the informed consent form

Who Cannot Join the Study?

Previous treatment with gedatolisib or darolutamide (medications used in this study)
Female patients (this study is designed for male patients only)
Age under 18 years
Patients who belong to vulnerable populations (such as those who cannot make decisions for themselves)
Known allergies or hypersensitivity to the study medications or their components
Participation in another clinical trial within the past 30 days
Presence of other types of cancer besides prostate cancer
Severe heart, liver, or kidney problems
Uncontrolled high blood pressure
History of significant bleeding disorders
Major surgery within the past 4 weeks
Any condition that, in the opinion of the study doctor, would make participation unsafe
Inability or unwillingness to follow study procedures

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Jean Perrin	Clermont Ferrand	France
Institut Gustave Roussy	Villejuif	France

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Issilrct Cxetds Dtdmdvzogkwpzvguk	L'hospitalet De Llobregat	Spain
Ihysqeon Pcyjylelhdyrfoq Cdhxwq Cileee	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.02.2024
Spain	Recruiting	01.02.2024

Trial locations

Investigated drugs:

Gedatolisib is an investigational medication that works by blocking specific proteins involved in cancer cell growth. It targets two important pathways (PI3K and mTOR) that can help control the spread of prostate cancer cells.

Darolutamide is a medication used to treat prostate cancer. It works by blocking the effects of male hormones (androgens) that can stimulate cancer growth. It is specifically designed to treat prostate cancer that continues to grow even when the testosterone levels in the body are very low (a condition known as castration-resistant prostate cancer).

This trial studies these two medications used together to treat men with metastatic castration-resistant prostate cancer, which is prostate cancer that has spread to other parts of the body and continues to grow despite treatments that lower testosterone levels.

Investigated diseases:

Prostate cancer metastatic

Metastatic Castration-Resistant Prostate Cancer (mCRPC) – A progressive form of prostate cancer that continues to spread despite medical or surgical treatments that lower testosterone. In this condition, cancer cells have spread beyond the prostate to other parts of the body and continue to grow even when testosterone levels are very low. The disease develops from regular prostate cancer when cancer cells adapt to survive and multiply with minimal testosterone. This progression typically involves changes in how cancer cells respond to hormones and may be accompanied by the appearance of new tumor sites in bones, lymph nodes, or other organs.

Trial ID:

2023-505898-32-00

Protocol code:

CELC-G-201

NCT ID:

NCT06190899

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of Gedatolisib and Darolutamide Combination Treatment for Patients with Metastatic Castration-Resistant Prostate Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?