Prostate CancerPhase 1ASCERTAINNCT05938270
A Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer.
A Phase 1 study testing Saruparib (AZD5305), Darolutamide and No Treatment in people with Prostate Cancer, run by AstraZeneca at 16 sites in 6 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Saruparib (AZD5305), Darolutamide and No Treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 16 sitesin 6 countries
- Study dates
- 21 Sep 2023to 15 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, including, active bleeding diatheses, or active infection including HepB, hepatitis C and HIV. Screening for chronic conditions is not required.
- Active HBV is defined by a known positive HBsAg result. Participants with a past or resolved HBV infection (defined as the presence of HepB antibody and absence of HBsAg) are eligible.
- Participants positive for HCV antibody are eligible only if PCR is negative for HCV RNA.
- Participants with any known predisposition to bleeding (eg, active peptic ulceration, recent [within 6 months] haemorrhagic stroke, proliferative diabetic retinopathy).
- Participants with history of MDS/AML or with features suggestive of MDS/AML (as determined by prior diagnostic investigation). In case there is no Clinical MDS/AML suspicion, no specific screening for MDS/AML (by bone marrow/bone biopsy) is required.
- Prior malignancy within 3 years of screening whose natural history, in the Investigator's opinion, has the potential to interfere with safety and efficacy assessments of the investigational regimen.
Show all 34Show fewer
- Concomitant use of drugs that are known to prolong or shorten QT and have a known risk of TdP.
- Any of the following cardiac criteria:
- Mean resting corrected QT interval (QTcF) > 450 milliseconds or QTcF < 340 milliseconds obtained from triplicate ECGs and averaged, recorded within 5 minutes.
- Any factors that increase the risk of QT prolongation, shortening or risk of arrhythmic events such as hypokalaemia, congenital long or short QT syndrome, family history of long QT syndrome, familial short QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong or shorten the QT interval.
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG eg, complete left bundle branch block, second or third degree atrioventricular block and clinically significant sinus node dysfunction not treated with pacemaker.
- Other CVS diseases as defined by any of the following:
- Symptomatic heart failure (as defined by NYHA class ≥ 2).
- uncontrolled hypertension.
- hypertensive heart disease with significant left ventricular hypertrophy.
- History of acute coronary syndrome/acute myocardial infarction, unstable angina pectoris, coronary intervention procedure with percutaneous coronary intervention or coronary artery bypass grafting within 6 months prior to screening.
- cardiomyopathy of any aetiology.
- presence of clinically significant valvular heart disease.
- history of atrial or ventricular arrhythmia requiring acute treatment; participants with atrial fibrillation and optimally controlled ventricular rate (heart rate < 100 bpm) are permitted.
- transient ischaemic attack, or stroke within 6 months prior to screening.
- participants with symptomatic hypotension at screening.
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of Saruparib (AZD5305).
- History of prior malignancy, treated with chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, or other anticancer agent within 3 years of screening. Previously localised surgically treated malignancy is acceptable, if no evidence of recurrence.
- Known allergy or hypersensitivity to investigational product(s) or any of the excipients of the investigational product(s).
- Prior treatment with any systemic or localised anti-cancer treatment for the localised prostate cancer.
- During the 4 weeks prior to the first dose, receiving immune modulatory agents including but not limited to, continuous corticosteroids at a dose of > 10 mg prednisone/day or equivalent.
- Concomitant use of medications or herbal supplements known to be:
- Strong CYP3A4 inducers/inhibitors (applies for Saruparib (AZD5305) and Saruparib (AZD5305) + darolutamide arms)
- Strong or moderate CYP3A4 and P-glycoprotein inducers (applies to darolutamide arm and Saruparib (AZD5305) + darolutamide arm) This is including, but not limited to, the prohibited medications listed in CSP Appendix G, or inability to stop the use thereof, at least 21 days or at least 5 half-lives (whichever is longer) before the first dose of study treatment until 30 days after the last dose of study treatment.
- Treatment with any investigational agents or study interventions from a previous clinical study within 5 half-lives or 3 weeks (whichever is longer) of the first dose of study treatment.
- Participants with contraindication to darolutamide for treatment arms
- Unable to comply with the visits and assessments.
- In the opinion of the Investigators should not be included in this study.
- No treatment arm only: if any participant meets exclusion 4, 9 or 11, they are not to be included in the study.
Trial locations and contacts
16 sites in 6 countries.
16 sites in 6 countries
Spain4 sites
Research Site
Barcelona, 08036
Research Site
Barcelona, 8035
Research Site
Madrid, 28041
Research Site
Valencia, 46009
Canada3 sites
Research Site
Québec, Quebec, G1J 1Z4
Research Site
Toronto, Ontario, M5G 2M9
Research Site
Vancouver, British Columbia, V5Z 1M9
United Kingdom3 sites
Research Site
Cambridge, CB2 0QQ
Research Site
Manchester, M20 4BX
Research Site
Newcastle upon Tyne, NE7 7AF
United States2 sites
Research Site
Detroit, Michigan, 48202
Research Site
Providence, Rhode Island, 02903
Australia2 sites
Research Site
Melbourne, VIC 3000
Research Site
South Brisbane, 4101
Netherlands2 sites
Research Site
Amsterdam, 1066CX
Research Site
Nijmegen, 6525 GA
About this study
Official title: 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) Alone, Darolutamide Alone, and in Combination Given Prior to Radical Prostatectomy in Men with Newly Diagnosed Prostate Cancer (ASCERTAIN).
Read the detailed description
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).
- Conditions
- Prostate Cancer
- Being tested
- Saruparib (AZD5305), Darolutamide, No Treatment
- Keywords
- Prostate cancer, radical prostatectomy, Darolutamide, Saruparib (AZD5305)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saruparib (AZD5305)Drug
Also called Darolutamide is also known as Nubeqa
Saruparib (AZD5305) given orally once daily
DarolutamideDrug
Also called Darolutamide is also known as Nubeqa
Darolutamide tablet is 300mg, given BD orally, twice daily- total dose 1200mg
No TreatmentOther
No study treatment is to be taken by the participants in this arm. Radical prostatectomy should be performed as per local practice
| Study group | Role | What they receive |
|---|---|---|
| Saruparib (AZD5305) only | Other | 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) Receives: Drug: Saruparib (AZD5305) |
| Saruparib (AZD5305) + Darolutamide | Other | 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). Receives: Drug: Saruparib (AZD5305); Drug: Darolutamide |
| No Treatment | Other | No study treatment is to be taken by the participants in this arm. Radical prostatectomy should be performed as per local practice Receives: Other: No Treatment |
| Darolutamide Only | Other | 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). Receives: Drug: Darolutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fold change in % γH2AX positive cells from baseline value in tumour samples
To assess the effects of study treatment on γH2AX change in participants with localised prostate cancer
Measured: Tumour biopsy taken at diagnosis within approx 2 months of Day 1 planned start of study treatment; post treatment tumour biopsy taken following 21 days (+ up to 7 days) of study treatment
Secondary outcomes (10)
Severity of Treatment-Emergent AEs/SAEs per CTCAE v5.0
To assess the safety and tolerability of study treatment in participants with localised prostate cancer
Measured: Day 1 to 28 days post-surgery
Incidence of Treatment-Emergent AEs/SAEs per CTCAE v5.0
To assess the safety and tolerability of study treatment in participants with localised prostate cancer
Measured: Day 1 to 28 days post-surgery
Number of patients with abnormal laboratory values
To assess the safety and tolerability of study treatment in participants with localised prostate cancer
Measured: Day 1 to 28 days post-surgery
Change from baseline in blood pressure reported as clinically significant
To assess the safety of study treatment in participants with localised prostate cancer
Measured: Day 1 to 28 days post-surgery
Change from baseline in heart rate reported as clinically significant
To assess the safety of study treatment in participants with localised prostate cancer
Measured: Day 1 to 28 days post-surgery
Change from baseline in QTc value
To assess the safety of study treatment in participants with localised prostate cancer
Measured: Day 1 to 28 days post-surgery
Number of participants undergoing planned surgery
To assess the impact of study treatment on surgical feasibility in participants with localised prostate cancer
Measured: Measured based on Day 1 to Day 21 of treatment
Reasons of participants requiring treatment-related and non-treatment related delays of surgery and delays > 7 days from scheduled day
To assess the impact of study treatment on surgical feasibility in participants with localised prostate cancer
Measured: Measured based on Day 1 to Day 21 of treatment
Number of participants requiring treatment-related and non-treatment related delays of surgery and delays > 7 days from scheduled day
To assess the impact of study treatment on surgical feasibility in participants with localised prostate cancer
Measured: Measured based on Day 1 to Day 21 of treatment
Change in Ki-67 % positive cells from baseline in tumour samples
To assess the effects of study treatment on Ki-67 change in participants with localised prostate cancer
Measured: Measured based on Day 1 to Day 21 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start21 Sep 2023
- Primary completion15 Jun 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, phase 1 multicentre study
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938270
- Sponsor's protocol ID
- D9721C00002
- Other IDs
- 2023-503691-25-00, 2023
- Acronym
- ASCERTAIN
- Status last verified
- Jun 2026
- First submitted
- 16 May 2023
- Last updated
- 30 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05938270
- Acronym / sponsor ID
- ASCERTAIN / D9721C00002
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, radical prostatectomy, Darolutamide, Saruparib (AZD5305)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomised, phase 1 multicentre study
| Arm | Type | Receives |
|---|---|---|
| Saruparib (AZD5305) only | Other | Drug: Saruparib (AZD5305)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) |
| Saruparib (AZD5305) + Darolutamide | Other | Drug: Saruparib (AZD5305), Drug: DarolutamideParticipant 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 Treatment | Other | Other: No TreatmentNo study treatment is to be taken by the participants in this arm. Radical prostatectomy should be performed as per local practice |
| Darolutamide Only | Other | Drug: DarolutamideParticipant 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (34 listed)
- As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, including, active bleeding diatheses, or active infection including HepB, hepatitis C and HIV. Screening for chronic conditions is not required.
- Participants with any known predisposition to bleeding (eg, active peptic ulceration, recent [within 6 months] haemorrhagic stroke, proliferative diabetic retinopathy).
- Participants with history of MDS/AML or with features suggestive of MDS/AML (as determined by prior diagnostic investigation). In case there is no Clinical MDS/AML suspicion, no specific screening for MDS/AML (by bone marrow/bone biopsy) is required.
- Prior malignancy within 3 years of screening whose natural history, in the Investigator's opinion, has the potential to interfere with safety and efficacy assessments of the investigational regimen.
- Concomitant use of drugs that are known to prolong or shorten QT and have a known risk of TdP.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saruparib (AZD5305)Also: Darolutamide is also known as NubeqaSaruparib (AZD5305) given orally once daily | Drug | Saruparib (AZD5305) + Darolutamide, Saruparib (AZD5305) only |
| DarolutamideAlso: Darolutamide is also known as NubeqaDarolutamide tablet is 300mg, given BD orally, twice daily- total dose 1200mg | Drug | Darolutamide Only, Saruparib (AZD5305) + Darolutamide |
| No TreatmentNo study treatment is to be taken by the participants in this arm. Radical prostatectomy should be performed as per local practice | Other | No Treatment |
Primary outcome
Fold change in % γH2AX positive cells from baseline value in tumour samples
Time frame: Tumour biopsy taken at diagnosis within approx 2 months of Day 1 planned start of study treatment; post treatment tumour biopsy taken following 21 days (+ up to 7 days) of study treatment
To assess the effects of study treatment on γH2AX change in participants with localised prostate cancer
10 secondary outcomes
Severity of Treatment-Emergent AEs/SAEs per CTCAE v5.0
Time frame: Day 1 to 28 days post-surgery
Incidence of Treatment-Emergent AEs/SAEs per CTCAE v5.0
Time frame: Day 1 to 28 days post-surgery
Number of patients with abnormal laboratory values
Time frame: Day 1 to 28 days post-surgery
Change from baseline in blood pressure reported as clinically significant
Time frame: Day 1 to 28 days post-surgery
Change from baseline in heart rate reported as clinically significant
Time frame: Day 1 to 28 days post-surgery
Change from baseline in QTc value
Time frame: Day 1 to 28 days post-surgery
Number of participants undergoing planned surgery
Time frame: Measured based on Day 1 to Day 21 of treatment
Reasons of participants requiring treatment-related and non-treatment related delays of surgery and delays > 7 days from scheduled day
Time frame: Measured based on Day 1 to Day 21 of treatment
Number of participants requiring treatment-related and non-treatment related delays of surgery and delays > 7 days from scheduled day
Time frame: Measured based on Day 1 to Day 21 of treatment
Change in Ki-67 % positive cells from baseline in tumour samples
Time frame: Measured based on Day 1 to Day 21 of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Saruparib (AZD5305), Darolutamide and No Treatment in people with Prostate Cancer, run by AstraZeneca at 16 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Spain, Canada, United Kingdom, United States, Australia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fold change in % γH2AX positive cells from baseline value in tumour samples (time frame: Tumour biopsy taken at diagnosis within approx 2 months of Day 1 planned start of study treatment; post treatment tumour biopsy taken following 21 days (+ up to 7 days) of study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.