A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer.

Researchers are looking for a better way to treat men who have high-risk localized prostate cancer, which refers to a type of prostate cancer that is still confined to the prostate gland but has certain characteristics that make it more likely to grow and spread. The study treatment darolutamide plus androgen deprivation therapy (ADT) is under development as treatment before surgery for men who have high-risk localized prostate cancer. Darolutamide works by blocking the attachment of androgen hormones to androgen receptors in cancer cells, thereby blocking cancer progression and growth. ADT i

Trial Details

NCT ID
NCT07450599
Phase
PHASE2
Sponsor
Bayer
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • Darolutamide
  • ADT
Locations (sample)
  • Hefei, Anhui, China|31.86389,117.28083
  • Guangzhou, Guangdong, China|23.11667,113.25
  • Shijiazhuang, Hebei, China|38.04139,114.47861
  • Harbin, Heilongjiang, China|45.75,126.65
  • Nanjing, Jiangsu, China|32.06167,118.77778

Key Eligibility Criteria

  • Participants must be 18 years or older at the time of signing the informed consent.
  • Darolutamide-naïve participants who are with localized prostate adenocarcinoma who plan to receive radical prostatectomy (RP) and defined as high r…
  • No evidence of distant metastasis based on computed tomography (CT), magnetic resonance imaging (MRI), and whole body bone scan (WBBS) within 42 da…
  • Candidate for RP with pelvic lymph node dissection (PLND) or extended PLND (ePLND) as per the investigator.

For full eligibility, visit ClinicalTrials.gov.

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