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

NCT 05938270

Brief Summary

A Study to Investigate the Biological Effects of Saruparib (AZD5305) Alone, Darolutamide Alone, and in Combination Given Prior to Radical Prostatectomy in Men with Newly Diagnosed Prostate Cancer (ASCERTAIN).

Intervention / Treatment 

  • DrugSaruparib (AZD5305)
  • DrugDarolutamide
  • OtherNo Treatment

 

Inclusion Criteria:

  • male participants >/= 18 years old
  • participants deemed suitable for radical prostatectomy
  • participants with localised prostate cancer with unfavourable intermediate/high/very high risk eligible for prostatectomy
  • adequate organ and marrow function as per protocol
  • capable of giving signed informed consent
  • For participants participating in the Optional Genetic Research Only: Provision of signed and dated written Optional Genetic Research Information
  • Available FFPE diagnostic tumour biopsy samples
  • Participants must use a condom (with spermicide) from screening to 6 months after screening and refrain from fathering a child or donating sperm.

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