A Safety and Dose-finding Study of PRL-02 Depot in Men With Advanced Prostate Cancer

Medicines that reduce the amount of testosterone in the body are commonly used to treat prostate cancer. PRL-02 depot is a potential treatment for men with advanced prostate cancer. It is given by an injection into the muscle. Men with advanced prostate cancer can take part in this study. Their cancer has come back after previous cancer treatment, or the previous cancer treatment they had didn't work. The main aims of the study are: * to check the safety of PRL-02 depot given with and without another medicine called enzalutamide. * to check if the men can tolerate PRL-02 depot given with or

Trial Details

NCT ID
NCT04729114
Phase
PHASE1
Sponsor
Astellas Pharma Global Development, Inc.
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • PRL-02 injection
  • prednisone
  • dexamethasone
  • enzalutamide
Locations (sample)
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Anaheim, California, United States|33.83529,-117.9145
  • Santa Rosa, California, United States|38.44047,-122.71443
  • Tampa, Florida, United States|27.94752,-82.45843
  • Fort Wayne, Indiana, United States|41.1306,-85.12886

Key Eligibility Criteria

  • Histological evidence of adenocarcinoma of the prostate
  • Phase 1a Dose Escalation Groups A and B: participants must have one of the following documented conditions:
  • mCSPC (must have documentation by positive bone scan \[for bone disease\] or metastatic lesions on computed tomography \[CT\] or magnetic resonance…
  • nmCSPC with biochemical relapse of prostate cancer

For full eligibility, visit ClinicalTrials.gov.

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