Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents
Launched by ASTRAZENECA · Nov 6, 2023
Trial Information
Current as of May 01, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating a new treatment called Saruparib (AZD5305) for men with metastatic castration-sensitive prostate cancer, which means their cancer has spread but still responds to hormonal therapies. The goal of the study is to see if Saruparib, when given along with a doctor's choice of hormonal agents, is more effective than a placebo (a dummy treatment) plus the same hormonal agents. Researchers will look at how long patients can go without their cancer getting worse using imaging tests like CT scans or MRIs.
To be eligible for this trial, participants must be men aged 18 or older with a confirmed diagnosis of prostate cancer that has spread. They should have evidence of metastatic disease and be receiving androgen deprivation therapy (ADT) or have had surgery to remove their testicles recently. Participants need to be in good general health and provide tissue and blood samples for testing. It's important to note that those with certain health issues or previous treatments for prostate cancer may not qualify. If eligible, participants will receive either Saruparib or a placebo and will have regular check-ups to monitor their health and the progression of their cancer.
Gender
MALE
Eligibility 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 (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.
About Astrazeneca
AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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Kanpur, , India
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Goztepe Istanbul, , Turkey
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Porto Alegre, , Brazil
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Jaipur, , India
Bala Cynwyd, Pennsylvania, United States
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Vadodara, , India
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Braunschweig, , Germany
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Concepcion, , Chile
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Varanasi, , India
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Suining, , China
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Babylon, New York, United States
Fatih Istanbul, , Turkey
Shirley, New York, United States
Hyde Park, , Australia
São Paulo, , Brazil
Abbotsford, British Columbia, Canada
Malmo, , Sweden
Pierre Bénite, , France
Fayetteville, North Carolina, United States
Rio De Janeiro, , Brazil
Sao Luis, , Brazil
Rio Rancho, New Mexico, United States
Florence, Oregon, United States
Nagoya, , Japan
Upper Marlboro, Maryland, United States
Independence, Ohio, United States
Charleroi, , Belgium
Calgary, Alberta, Canada
Birmingham, , United Kingdom
Patients applied
Trial Officials
Kim Nguyen Chi, MD
Principal Investigator
BC Cancer, Canada
Arun Azad, MD
Principal Investigator
Peter MacCallum Cancer Centre, Australia
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported