Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Participant will receive Saruparib (AZD5305) once daily for 21 days (+ up to 7 days) unless unacceptable toxicity or withdrawal of consent. Following the 21 days of study treatment, participants should undergo radical prostatectomy on Day 22 (+ up to 7 days)

Participant will receive Saruparib (AZD5305) once daily + darolutamide twice daily for 21 days (+ up to 7 days) unless unacceptable toxicity or withdrawal of consent. Following the 21 days of study treatment, participants should undergo radical prostatectomy on Day 22 (+ up to 7 days).

No study treatment is to be taken by the participants in this arm. Radical prostatectomy should be performed as per local practice

Participant will receive darolutamide twice daily for 21 days (+ up to 7 days) unless unacceptable toxicity or withdrawal of consent. Following the 21 days of study treatment, participants should undergo radical prostatectomy on Day 22 (+ up to 7 days).

Saruparib (AZD5305) given orally once daily

Saruparib (AZD5305)

Darolutamide tablet is 300mg, given BD orally, twice daily- total dose 1200mg

Darolutamide

No Treatment

AstraZeneca Clinical Study Information Center

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)

An Open-label, Randomised, Phase-I, Multi-Centre 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)

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

An Open-label, Randomised, Phase-I, Multi-Centre 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)

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal

Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved

To assess the effects of study treatment on γH2AX change in participants with localised prostate cancer

To assess the safety and tolerability of study treatment in participants with localised prostate cancer

To assess the safety of study treatment in participants with localised prostate cancer

To assess the impact of study treatment on surgical feasibility in participants with localised prostate cancer

To assess the effects of study treatment on Ki-67 change in participants with localised prostate cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer.	NCT05938270	Prostate Cancer	Saruparib (AZD5... Darolutamide No Treatment	18 Years -	AstraZeneca
A Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer.	NCT05938270	Prostate Cancer	Saruparib (AZD5... Darolutamide No Treatment	18 Years -	AstraZeneca
A Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer.	NCT05938270	Prostate Cancer	Saruparib (AZD5... Darolutamide No Treatment	18 Years -	AstraZeneca

Spots Global Cancer Trial Database for prostate cancer, radical prostatectomy, darolutamide, saruparib (azd5305)