New hope for tough prostate cancer? early trial launches
NCT ID NCT07103018
First seen Nov 01, 2025 · Last updated Jun 23, 2026 · Updated 35 times
Summary
This early-stage trial tests a new drug called KTX-2001, alone or with another drug (darolutamide), in men with metastatic castration-resistant prostate cancer that has spread and stopped responding to hormone therapy. The main goals are to check safety, find the right dose, and see if the drug works. About 144 men will take part.
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Contacts and locations
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Study contacts
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Contact
Phone: •••-•••-•••• Email: •••••@•••••
Locations
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Carolina Urologic Research Center, the START Center for Cancer Research
RECRUITINGMyrtle Beach, South Carolina, 29572, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact
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Columbia University Irving Medical Center
RECRUITINGNew York, New York, 10032, United States
Contact
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Duke Cancer Center
RECRUITINGDurham, North Carolina, 27710, United States
Contact
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Hematology Oncology Associates of the Treasure Coast
RECRUITINGPort Saint Lucie, Florida, 34952, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact
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Mayo Clinic
NOT_YET_RECRUITINGRochester, Minnesota, 55905, United States
Contact Phone: •••-•••-••••
Contact
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Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10032, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact
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NYU Langone Health
RECRUITINGNew York, New York, 10016, United States
Contact
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START New York Long Island, LLC
RECRUITINGNew Hyde Park, New York, 11042, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact
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Sylvester Comprehensive Cancer Center
RECRUITINGMiami, Florida, 33136, United States
Contact
Contact Phone: •••-•••-•••• Email: •••••@•••••
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The Ohio State University Comprehensive Cancer Center
NOT_YET_RECRUITINGColumbus, Ohio, 43210, United States
Contact
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USA Clinical Trials
RECRUITINGSan Antonio, Texas, 78229, United States
Contact
Contact Phone: •••-•••-•••• Email: •••••@•••••
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University of California San Francisco
RECRUITINGSan Francisco, California, 94158, United States
Contact Email: •••••@•••••
Contact
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University of Wisconsin
RECRUITINGMadison, Wisconsin, 53705, United States
Contact
Contact Phone: •••-•••-•••• Email: •••••@•••••
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
KTX-2001 (an NSD2 inhibitor) and darolutamide
What this could lead to
If successful, this could point toward a new treatment option for men with advanced prostate cancer that has stopped responding to standard hormone therapy.
What could go wrong
This is a very early Phase 1 trial with only 144 participants, so safety and dosing are still being figured out. The drug may not shrink tumors or improve survival, and side effects are unknown.
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.