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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06120491




Registration number
NCT06120491
Ethics application status
Date submitted
17/10/2023
Date registered
7/11/2023

Titles & IDs
Public title
Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents
Scientific title
A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of Saruparib (AZD5305) in Combination With Physician's Choice New Hormonal Agents in Patients With HRRm and Non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01)
Secondary ID [1] 0 0
2023-504214-30-00
Secondary ID [2] 0 0
D9723C00001
Universal Trial Number (UTN)
Trial acronym
EvoPAR-PR01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Castration-Sensitive Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Saruparib
Treatment: Drugs - Placebo
Treatment: Drugs - Abiraterone Acetate
Treatment: Drugs - Darolutamide
Treatment: Drugs - Enzalutamide

Experimental: Arm 1: Saruparib (AZD5305) + Physician's Choice NHA - Saruparib (AZD5305) + physician's choice NHA (Abiraterone, Darolutamide, or Enzalutamide)

Placebo comparator: Arm 2: Placebo + Physician's Choice NHA - Placebo + physician's choice NHA (Abiraterone, Darolutamide, or Enzalutamide)


Treatment: Drugs: Saruparib
Oral

Treatment: Drugs: Placebo
Oral

Treatment: Drugs: Abiraterone Acetate
Oral

Treatment: Drugs: Darolutamide
Oral

Treatment: Drugs: Enzalutamide
Oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Radiographic Progression-Free Survival (rPFS)
Timepoint [1] 0 0
up to approximately 50 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
up to approximately 90 months
Secondary outcome [2] 0 0
Second Progression-Free Survival (PFS2)
Timepoint [2] 0 0
up to approximately 50 months
Secondary outcome [3] 0 0
Time to First Subsequent Therapy or Death (TFST)
Timepoint [3] 0 0
up to approximately 50 months
Secondary outcome [4] 0 0
Symptomatic Skeletal Event-Free Survival (SSE-FS)
Timepoint [4] 0 0
up to approximately 50 months
Secondary outcome [5] 0 0
Time to the First Castration-Resistant Event (TTCR)
Timepoint [5] 0 0
up to approximately 50 months
Secondary outcome [6] 0 0
Time to Pain Progression (TTPP)
Timepoint [6] 0 0
up to approximately 50 months
Secondary outcome [7] 0 0
Time To Deterioration in Urinary Symptoms (TTDUS)
Timepoint [7] 0 0
up to approximately 50 months
Secondary outcome [8] 0 0
Time to Deterioration in Fatigue (TTDF)
Timepoint [8] 0 0
up to approximately 50 months
Secondary outcome [9] 0 0
Time to Deterioration in Physical Function (TTDPF)
Timepoint [9] 0 0
up to approximately 50 months
Secondary outcome [10] 0 0
Health-related Quality of Life (HrQoL)
Timepoint [10] 0 0
up to approximately 50 months
Secondary outcome [11] 0 0
BRCA and other HRR gene mutation status.
Timepoint [11] 0 0
at screening
Secondary outcome [12] 0 0
Plasma concentrations of AZD5305
Timepoint [12] 0 0
up to approximately 10 months
Secondary outcome [13] 0 0
Samples will be used to develop complementary or companion diagnostics by analyzing their performance characteristics and calculate their consistency with clinical trial assays used for enrolment onto the study.
Timepoint [13] 0 0
up to approximately 50 months
Secondary outcome [14] 0 0
Assessment of PSA (prostate-specific antigen) in participants in mCSPC
Timepoint [14] 0 0
up to approximately 50 months

Eligibility
Key inclusion criteria
* Male = 18 years of age.
* Histologically documented prostate adenocarcinoma which is de novo or recurrent and castration-sensitive. Participants with pathologic features of small cell, neuroendocrine, sarcomatoid, spindle cell, or signet cell histology are not eligible.
* Metastatic disease as documented by the investigator prior to randomisation, with clear evidence of = 1 bone lesion and/or = 1 soft tissue lesion that is suitable for repeated assessment with CT and/or MRI.
* Participant is receiving ADT with a GnRH analogue or has undergone bilateral orchiectomy starting = 14 days and < 4 months prior to randomisation.
* ECOG performance status of 0 or 1 with no deterioration over the 2 weeks prior to randomisation.
* Provision of FFPE tumour tissue sample and blood sample (for ctDNA).
* Confirmed HRRm status by central tumour tissue and/or ctDNA test is required to determine cohort eligibility.
* Adequate organ and bone marrow function as described in study protocol.
* Participants must not father children or donate sperm from signing ICF, during the study intervention and for 6 months after the last dose of study intervention.
* Participants must use a condom from signing ICF, during study intervention, and for 6 months after the last dose of study drug, with all sexual partners.
Minimum age
18 Years
Maximum age
130 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants with a 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 BM/bone biopsy) is required.
* Participants with any known predisposition to bleeding.
* Any history of persisting (> 2 weeks) severe cytopenia.
* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD5305 and/or the assigned NHA.
* History of another primary malignancy, with exceptions.
* Persistent toxicities (CTCAE Grade = 2) caused by previous anticancer therapy.
* Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.
* Cardiac criteria, including history of arrhythmia and cardiovascular disease.
* Any prior anticancer pharmacotherapy or surgery for metastatic prostate cancer, with exceptions.
* Prior treatment within 14 days with blood product support or growth factor support.
* Participants who are unevaluable for both bone and soft tissue progression.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/04/2031
Actual
Sample size
Target
1800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
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Research Site - Chermside
Recruitment hospital [2] 0 0
Research Site - Darlinghurst
Recruitment hospital [3] 0 0
Research Site - Hyde Park
Recruitment hospital [4] 0 0
Research Site - Kurralta Park
Recruitment hospital [5] 0 0
Research Site - Melbourne
Recruitment hospital [6] 0 0
Research Site - Randwick
Recruitment hospital [7] 0 0
Research Site - South Brisbane
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4032 - Chermside
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
4812 - Hyde Park
Recruitment postcode(s) [4] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [5] 0 0
3000 - Melbourne
Recruitment postcode(s) [6] 0 0
2031 - Randwick
Recruitment postcode(s) [7] 0 0
4101 - South Brisbane
Recruitment outside Australia
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Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kim Nguyen Chi, MD
Address 0 0
BC Cancer, Canada
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06120491