Clin2
NCT05116475Possibly a fitRecruiting

New prostate cancer trial adding darolutamide to standard treatment

Prostate Cancer

Treatments studied

Part of Cancer, Kidney & urinary clinical trials.

This Phase 3 trial tests whether adding darolutamide to standard hormone therapy and radiation works better than standard treatment alone for newly diagnosed prostate cancer that has spread to pelvic lymph nodes. If you qualify, you may receive darolutamide or a placebo alongside long-term hormone therapy and radiation.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 3
Enrollment
152 people
Ages
18 years to 120 years
Study type
Interventional

Who can take part

  • You have newly diagnosed prostate cancer confirmed by biopsy (prostate adenocarcinoma).
  • You are 18 or older.
  • Scans show prostate cancer has spread only to pelvic lymph nodes (not outside the pelvis), and you have no bone or organ metastases.
  • Your cancer staging includes a pelvic MRI plus a CT/bone scan or PET-CT (choline or PSMA).
  • You plan to take long-term hormone therapy for 24 months, and you can start within 3 months of randomization.
  • Your health allows treatment: good enough blood counts and liver/kidney tests, and you can take pills and follow visits.

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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