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

NCT06120491

Active Not RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Metastatic Castration-Sensitive Prostate Cancer

Interventions: Saruparib, Placebo, Abiraterone Acetate, Darolutamide, Enzalutamide

Countries: United States, Australia, Austria, Belgium, Brazil, Canada, Chile, China

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 overview

Sex: MALE

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (322)
  • Chandler, Arizona, United States
  • Gilbert, Arizona, United States
  • Phoenix, Arizona, United States
  • Tucson, Arizona, United States
  • Little Rock, Arkansas, United States
  • Springdale, Arkansas, United States
  • Bakersfield, California, United States
  • Fountain Valley, California, United States
  • Fullerton, California, United States
  • Los Angeles, California, United States
  • Montebello, California, United States
  • San Francisco, California, United States
  • Santa Barbara, California, United States
  • Santa Monica, California, United States
  • Santa Rosa, California, United States
  • Golden, Colorado, United States
  • Lakewood, Colorado, United States
  • New Haven, Connecticut, United States
  • Atlanta, Georgia, United States
  • Glenview, Illinois, United States
  • Lake Barrington, Illinois, United States
  • Fort Wayne, Indiana, United States
  • Indianapolis, Indiana, United States
  • Westwood, Kansas, United States
  • Shreveport, Louisiana, United States
  • Scarborough, Maine, United States
  • Baltimore, Maryland, United States
  • Baltimore, Maryland, United States
  • Bethesda, Maryland, United States
  • Towson, Maryland, United States
  • + 292 more on CT.gov