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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
Date last updated
24/09/2024

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 90 months
Secondary outcome [3] 0 0
Time to First Subsequent Therapy or Death (TFST)
Timepoint [3] 0 0
up to approximately 90 months
Secondary outcome [4] 0 0
Symptomatic Skeletal Event-Free Survival (SSE-FS)
Timepoint [4] 0 0
up to approximately 90 months
Secondary outcome [5] 0 0
Time to the First Castration-Resistant Event (TTCR)
Timepoint [5] 0 0
up to approximately 90 months
Secondary outcome [6] 0 0
Time to Pain Progression (TTPP)
Timepoint [6] 0 0
up to approximately 90 months
Secondary outcome [7] 0 0
Time To Deterioration in Urinary Symptoms (TTDUS)
Timepoint [7] 0 0
up to approximately 90 months
Secondary outcome [8] 0 0
Time to Deterioration in Fatigue (TTDF)
Timepoint [8] 0 0
up to approximately 90 months
Secondary outcome [9] 0 0
Time to Deterioration in Physical Function (TTDPF)
Timepoint [9] 0 0
up to approximately 90 months
Secondary outcome [10] 0 0
Health-related Quality of Life (HrQoL)
Timepoint [10] 0 0
up to approximately 90 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 90 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 90 months
Secondary outcome [14] 0 0
PSA (prostate-specific antigen) undetectable rate at 6, 12 months
Timepoint [14] 0 0
up to approximately 90 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
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Research Site - Darlinghurst
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Research Site - Hyde Park
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Research Site - Kurralta Park
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Research Site - Melbourne
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Research Site - Randwick
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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
The intention of the study is to demonstrate superiority of Saruparib (AZD5305) + physician's choice NHA relative to placebo + physician's choice NHA by assessment of radiographic progression-free survival (rPFS) in participants with mCSPC.
Trial website
https://clinicaltrials.gov/study/NCT06120491
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06120491