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

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.

Eligibility

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 (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.

Conditions2

Interventions4

Locations118 sites

Find trials near these locations

Related trials

• Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer — The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Phase II Randomised Controlled Trial of Patient-specific Adaptive vs. Continuous Abiraterone or eNZalutamide in mCRPC — Leiden University Medical Center
• A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer — Astellas Pharma Global Development, Inc.
• A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study — Astellas Pharma Global Development, Inc.
• A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer — Amgen
• Risk Stratified De-escalated Hormone Therapy With Radiation Therapy for the Treatment of Prostate Cancer — Mayo Clinic
• A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004) — Merck Sharp & Dohme LLC
• Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial — Alliance for Clinical Trials in Oncology

Browse More Trials