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Darolutamide Clinical Trials

25 actively recruiting trials across 14 locations

Also known as: Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788, Darolutamide is also known as Nubeqa +7 more

Pipeline

Phase 1: 6Phase 2: 9Phase 3: 4Phase 1/2: 3Phase 2/3: 1

Top Sponsors

  • AstraZeneca2
  • Xijing Hospital1
  • Vandana Abramson1
  • University of California, Davis1
  • UNICANCER1

Indications

  • Cancer25
  • Prostate Cancer7
  • Metastatic Castration-resistant Prostate Cancer5
  • Metastatic Hormone-sensitive Prostate Cancer (mHSPC)3
  • Metastatic Hormone-sensitive Prostate Cancer2

Other9 trials

Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Phase 2
Docetaxel or Cabazitaxel With or Without Darolutamide in mCRPC
Phase 2
Neoadjuvant Therapy of Darolutamide Plus ADT for High Risk Prostate Cancer
Phase 2
Observational Study of the Effectiveness of Funded Drugs for Genitourinary Tumors.
ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer
Phase 3
Psma Intensity Can be Altered by Androgen and Phospho-SrC Obstruction
Phase 2
Study Evaluating the Efficacy and Safety of Darolutamide and Stereotactic Dose Escalated Radiotherapy in Patients With Localized Prostate Cancer and High-risk Features of Relapse
Phase 3
TT-702 in Patients With Advanced Solid Tumours.
Phase 1/2
Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers
Phase 2/3

Birmingham, Alabama2 trials

Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)

University of Alabama at Birmingham Hospital

Phase 1
Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial

University of Alabama at Birmingham Cancer Center

Phase 3

Detroit, Michigan2 trials

A Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer.

Research Site

Phase 1
Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer

Barbara Ann Karmanos Cancer Institute

Phase 1/2

Chandler, Arizona1 trial

Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents

Research Site

Phase 3

Phoenix, Arizona1 trial

Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial

Mayo Clinic in Arizona

Phase 2

Sacramento, California1 trial

Abiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate Cancer

University of California Davis Comprehensive Cancer Center

Phase 2

Orlando, Florida1 trial

Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer

AdventHealth Orlando

Phase 1

Sarasota, Florida1 trial

A Study of JNJ-78278343 in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Prostate Cancer

Florida Cancer Specialists

Phase 1

Wichita, Kansas1 trial

TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Wichita Urology Group PA

Phase 1/2

Baltimore, Maryland1 trial

Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Phase 2

Boston, Massachusetts1 trial

Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer

Dana Farber Cancer Institute

Phase 1

New York, New York1 trial

Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer

Icahn School of Medicine at Mount Sinai

Phase 2

Cleveland, Ohio1 trial

A Study to Learn About Real-world Utilization and Outcomes of Darolutamide and Other Androgen Receptor Pathway Inhibitors (ARPIs) for Newly Diagnosed Metastatic Hormone-sensitive Prostate Cancer (de Novo mHSPC) in US Urology Clinics

Precision Point Specialty LLC PPS Analytics, a Specialty Networks LLC Company

Myrtle Beach, South Carolina1 trial

A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)

Carolina Urologic Research Center

Phase 1

Nashville, Tennessee1 trial

Neoadjuvant Darolutamide Alone or in Combination With Standard Therapy for Stage II-IIIA, AR+, TNBC

Vanderbilt University/Ingram Cancer Center

Phase 2

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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