Informations générales (source: ClinicalTrials.gov)
A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of Saruparib (AZD5305) in Combination With Physician's Choice New Hormonal Agents in Patients With HRRm and Non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01)
Interventional
Phase 3
AstraZeneca (Voir sur ClinicalTrials)
novembre 2023
avril 2031
02 février 2026
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.
Etablissements
| Etablissement | Contact | Statut | Actualisé | ||
|---|---|---|---|---|---|
| Etablissement non spécifié, référez vous à la page NCT pour plus d'information Origine et niveau de fiabilité des données | |||||
Critères
Homme
- 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.