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OncoMatch/Clinical Trials/NCT05938270

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

Is NCT05938270 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Saruparib (AZD5305) and Darolutamide for prostate cancer.

Phase 1RecruitingAstraZenecaNCT05938270Data as of May 2026

Treatment: Saruparib (AZD5305) · DarolutamideA 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).

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Extracted eligibility criteria

Cancer type

Prostate Cancer

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic or localised anti-cancer treatment

Prior treatment with any systemic or localised anti-cancer treatment for the localised prostate cancer

Cannot have received: chemotherapy

Exception: Previously localised surgically treated malignancy is acceptable, if no evidence of recurrence.

History of prior malignancy, treated with chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, or other anticancer agent within 3 years of screening

Cannot have received: biological therapy

Exception: Previously localised surgically treated malignancy is acceptable, if no evidence of recurrence.

History of prior malignancy, treated with chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, or other anticancer agent within 3 years of screening

Cannot have received: radiation therapy

Exception: Previously localised surgically treated malignancy is acceptable, if no evidence of recurrence.

History of prior malignancy, treated with chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, or other anticancer agent within 3 years of screening

Cannot have received: androgen

Exception: Previously localised surgically treated malignancy is acceptable, if no evidence of recurrence.

History of prior malignancy, treated with chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, or other anticancer agent within 3 years of screening

Cannot have received: thalidomide

Exception: Previously localised surgically treated malignancy is acceptable, if no evidence of recurrence.

History of prior malignancy, treated with chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, or other anticancer agent within 3 years of screening

Cannot have received: immunotherapy

Exception: Previously localised surgically treated malignancy is acceptable, if no evidence of recurrence.

History of prior malignancy, treated with chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, or other anticancer agent within 3 years of screening

Cannot have received: anticancer agent

Exception: Previously localised surgically treated malignancy is acceptable, if no evidence of recurrence.

History of prior malignancy, treated with chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, or other anticancer agent within 3 years of screening

Lab requirements

Blood counts

adequate organ and marrow function as per protocol

Kidney function

adequate organ and marrow function as per protocol

Liver function

adequate organ and marrow function as per protocol

adequate organ and marrow function as per protocol

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Research Site · Detroit, Michigan
  • Research Site · Providence, Rhode Island

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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