AZD5305 vs Placebo in Men with Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents - EvoPAR-PR01

Study identifier:D9723C00001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:2023-504214-30-00

Will Be Recruiting

Official Title

A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of AZD5305 in Combination with Physician’s Choice New Hormonal Agents in Patients with HRRm and non-HRRm Metastatic Castration‑Sensitive Prostate Cancer (EvoPAR-Prostate01)

Medical condition

Metastatic Castration-Sensitive Prostate Cancer

Phase

Phase 3

Healthy volunteers

Study drug

AZD5305, Placebo, Abiraterone Acetate, Darolutamide, Enzalutamide

Sex

Male

Estimated Enrollment

1800

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 24 Nov 2023

Estimated Primary Completion Date: 14 Jan 2028

Estimated Study Completion Date: 28 Apr 2031

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2023 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

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.

Exclusion Criteria

- Participants with a history of MDS/AML or with features suggestive of MDS/AML
- 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 arrythmia 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

No locations available

Arms	Assigned Interventions
Experimental: Arm 1: AZD5305 + Physician's Choice NHA AZD5305 + physician’s choice NHA (Abiraterone, Darolutamide, or Enzalutamide)	Drug: AZD5305 Oral Drug: Abiraterone Acetate Oral Other Name: Zytiga Drug: Darolutamide Oral Other Name: Nubequa Drug: Enzalutamide Oral Other Name: Xtandi
Placebo Comparator: Arm 2: Placebo + Physician's Choice NHA Placebo + physician’s choice NHA (Abiraterone, Darolutamide, or Enzalutamide)	Drug: Placebo Oral Drug: Abiraterone Acetate Oral Other Name: Zytiga Drug: Darolutamide Oral Other Name: Nubequa Drug: Enzalutamide Oral Other Name: Xtandi

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Kim Nguyen Chi

BC Cancer, Canada