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

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AstraZeneca

Status and phase

Enrolling
Phase 3

Conditions

Metastatic Castration-Sensitive Prostate Cancer

Treatments

Drug: Abiraterone Acetate
Drug: Placebo
Drug: Darolutamide
Drug: Enzalutamide
Drug: Saruparib

Study type

Interventional

Funder types

Industry

Identifiers

NCT06120491
D9723C00001
2023-504214-30-00 (Other Identifier)

Details and patient eligibility

About

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.

Full description

Approximately 1800 adult participants with mCSPC will be assigned to one of two cohorts (550 HRRm and 1250 non-HRRm) and randomized in a 1:1 ratio to receive either Saruparib (AZD5305) with NHA or placebo with NHA. They will receive their assigned treatment and regular tumor evaluation scans until disease progression, or until treatment is stopped for another reason.

All patients will be followed for survival until the end of the study. Independent data monitoring committee (DMC) composed of independent experts will be convened to confirm the safety and tolerability of Saruparib + physicians choice NHA.

Enrollment

1,800 estimated patients

Sex

Male

Ages

18 to 130 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

1,800 participants in 2 patient groups, including a placebo group

Arm 1: Saruparib (AZD5305) + Physician's Choice NHA
Experimental group
Description:
Saruparib (AZD5305) + physician's choice NHA (Abiraterone, Darolutamide, or Enzalutamide)
Treatment:
Drug: Saruparib
Drug: Enzalutamide
Drug: Darolutamide
Drug: Abiraterone Acetate
Arm 2: Placebo + Physician's Choice NHA
Placebo Comparator group
Description:
Placebo + physician's choice NHA (Abiraterone, Darolutamide, or Enzalutamide)
Treatment:
Drug: Enzalutamide
Drug: Darolutamide
Drug: Placebo
Drug: Abiraterone Acetate

Trial contacts and locations

395

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Central trial contact

AstraZeneca Clinical Study Information Center

Data sourced from clinicaltrials.gov

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