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Study details
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Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
NCT IDNCT07142551ClinicalTrials.gov data as of Apr 2026
Phase

Phase 2

Target enrollment

60

Study length

about 8.3 years

Ages

18+

Sex

Male only

Locations

1 site in MD

What this study is about

Researchers are testing whether giving testosterone (a treatment) along with darolutamide can help men with advanced prostate cancer live longer. The trial will also look at how this treatment affects their quality of life, gene expression, and metabolism.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Take Darolutamide
  • 2.Take Luteinizing hormone-releasing hormone (LHRH) analogue
  • 3.Take Testosterone cypionate

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
OralInjection / IV

How treatment is administered

Treatment Assignment
All receive treatment

Everyone gets the investigational treatment.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Drug classes

darolutamide, gonadorelin, Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers) (Androgen Receptor Agonists)

Drug routes

oral (Oral Tablet), injection, intramuscular

Endpoints

Primary: Percent of subjects free of Clinical or radiographic free progression

Secondary: Number of patients with Clinical or Radiographic progression free survival, Objective Response to darolutamide, Overall Survival

Body systems

Oncology