EvoPAR-Prostate01 D9723C00001
A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of AZD5305 in Combination with Physician’s Choice New Hormonal Agents in Patients with HRRm and non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01)
Trial summary:
The intention of the study is to demonstrate superiority of AZD5305 + physician’s choice NHA relative to placebo + physician’s choice NHA by assessment of radiographic progression-free survival (rPFS) in participants with mCSPC.
Receptor status / problem studied:
Inclusion criteria
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.
Exclusion criteria
1) Participants with a history of MDS/AML or with features suggestive of MDS/AML.
2) Participants with any known predisposition to bleeding.
3) Any history of persisting (> 2 weeks) severe cytopenia.
4) 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.
5) History of another primary malignancy, with exceptions.
6) Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy.
7) Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.
8) Cardiac criteria, including history of arrythmia and cardiovascular disease.
9) Any prior anticancer pharmacotherapy or surgery for metastatic prostate cancer, with exceptions:
|— a) Prior treatment within 14 days with blood product support or growth factor support.
|— b) Participants who are unevaluable for both bone and soft tissue progression.
Trial Title
EvoPAR-Prostate01 / D9723C00001
Diagnosis
Prostate cancer
Type of trial
Pharmaceutical
Type of treatement
Medical Oncology
Phase
III