Phase 2 Prostate Cancer Trial, Recruiting NCT06190899 Sponsor: Celcuity Inc Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT06190899
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Men aged 18 years or older
  • People who have a confirmed diagnosis of prostate cancer (adenocarcinoma type), with less than 10% of a specific cell type called neuroendocrine cells, and no small cell component
  • People whose prostate cancer has spread to other parts of the body (metastatic) and is no longer responding to treatments that lower testosterone (castration-resistant)
  • People whose cancer spread is visible on standard scans such as CT scans, MRI, or bone scans (cancer visible only on a specific type of scan called PSMA PET will not count for joining purposes)
  • People whose cancer is continuing to grow, shown by rising PSA blood test results, growth in soft tissue tumours, or new or growing areas of cancer on bone scans
  • People who are still receiving hormone therapy to lower testosterone (such as LHRH injections), unless surgical removal of the testicles has already been performed
  • People with a good general health status, rated 0 or 1 on a standard medical scale (confirm with trial site)
  • People whose cancer got worse while being treated with one of a group of newer hormone-blocking medicines (such as abiraterone, enzalutamide, apalutamide, or darolutamide)
  • People who finished that hormone-blocking medicine at least 4 weeks before starting the trial
  • People who have had enough time since their last cancer treatment or surgery, with most side effects from those treatments having resolved
  • People with adequate functioning of bone marrow, liver, kidneys, and blood clotting (confirm with trial site)

Who may not be able to join:

  • People who have had another type of cancer, unless it was a non-melanoma skin cancer or another cancer that was fully treated with no signs of return for at least 3 years
  • People whose prostate cancer includes a small cell component or has 10% or more neuroendocrine type cells
  • People who have previously been treated with a specific group of targeted medicines that affect pathways called PI3K, AKT, or mTOR (confirm with trial site)
  • People who have had chemotherapy or radioactive drug treatments specifically for castration-resistant prostate cancer (some earlier chemotherapy treatments for hormone-sensitive prostate cancer may still be acceptable — confirm with trial site)
  • People with uncontrolled type 1 or type 2 diabetes
  • People with active or untreated cancer that has spread to the brain or the lining around the brain, unless it was previously treated, is stable, and meets specific conditions (confirm with trial site)
  • People with a significant history of heart or cardiovascular problems
  • People with digestive system conditions that would prevent oral medication from being properly absorbed, or a history of inflammatory bowel disease
  • People who are unable to swallow tablets or capsules

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 19 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Nadene Zack, MS, Celcuity Inc

Phone: 844-310-3900

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Celcuity Inc
Registry
ClinicalTrials.gov
Start date
1 January 2024
Est. completion
1 January 2028

Where this trial is recruiting

🇫🇷 France 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Phase 1: Assessment of the safety and tolerability of gedatolisib in combination with darolutamide in metastatic castration-resistant prostate cancer (mCRPC); Phase 1: Identification of the recommended Phase 2 dose (RP2D) of gedatolisib in combination with darolutamide in mCRPC; Phase 2: Assessment of the antitumor activity of gedatolisib in combination with darolutamide in each arm as demonstrated by radiographic progression-free survival (rPFS) by arm

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov