Georgia's Online Cancer Information Center

Find A Clinical Trial

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

Status
Active
Cancer Type
Prostate Cancer
Unknown Primary
Trial Phase
Phase III
Eligibility
18 - 130 Years, Male
Study Type
Treatment
NCT ID
NCT06120491
Protocol IDs
D9723C00001 (primary)
NCI-2024-00268
2023-504214-30-00
Study Sponsor
AstraZeneca Pharmaceuticals LP

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.

Objectives

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 (AZD5305) + physicians choice NHA.

Eligibility

  1. Male = 18 years of age.
  2. 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.
  3. 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.
  4. Participant is receiving ADT with a GnRH analogue or has undergone bilateral orchiectomy starting = 14 days and < 4 months prior to randomisation.
  5. ECOG performance status of 0 or 1 with no deterioration over the 2 weeks prior to randomisation.
  6. Provision of FFPE tumour tissue sample and blood sample (for ctDNA).
  7. Confirmed HRRm status by central tumour tissue and/or ctDNA test is required to determine cohort eligibility.
  8. Adequate organ and bone marrow function as described in study protocol.
  9. 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.
  10. 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.
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.