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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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 trial?

14 criteria

  • 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 trial?

13 criteria

  • 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
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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.

What is already known about the treatment

  • Gedatolisib

    An investigational drug administered intravenously that works by inhibiting both PI3K and mTOR pathways in cancer cells. This dual inhibitor is currently being studied in clinical trials for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in combination with other medications. The drug belongs to the class of targeted cancer therapies and works by blocking specific cellular signaling pathways that are involved in cancer cell growth and survival.

  • Darolutamide

    An oral androgen receptor inhibitor that is used in the treatment of prostate cancer, specifically for metastatic castration-resistant prostate cancer (mCRPC). The medication works by blocking the effects of male hormones (androgens) that can stimulate cancer growth, effectively preventing these hormones from binding to their receptors in cancer cells. This drug belongs to the class of hormone therapy medications and has been proven effective in clinical trials for extending survival in patients with prostate cancer.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-505898-32-00Protocol codeCELC-G-201Estimated enrolment54 patientsSponsorCelcuity Inc.

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