EvoPAR-Prostate01

JRCT ID: jRCT2031230562

Registered date:12/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Metastatic Castration-Sensitive Prostate Cancer
• Date of first enrollment: 19/01/2024
• Target sample size: 143
• Countries of recruitment: Australia,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,Chile,Japan,China,Japan,Finland,Japan,France,Japan,Germany,Japan,Hungary,Japan,India,Japan,Italy,Japan,Malaysia,Japan,Netherlands,Japan,Peru,Japan,Poland,Japan,South Korea,Japan,Spain,Japan,Sweden,Japan,Taiwan,Japan,Thailand,Japan,Turkey,Japan,United Kingdom,Japan,United States of America,Japan
• Study type: Interventional

Intervention(s)

Experimental arm: AZD5305 + Physician's Choice NHA (Abiraterone, Darolutamide, or Enzalutamide)
-Drug: AZD5305, Abiraterone Acetate, Darolutamide, Enzalutamide
Placebo Comparator arm: Placebo + Physician's Choice NHA (Abiraterone, Darolutamide, or Enzalutamide)
-Drug: Placebo, Abiraterone Acetate, Darolutamide, Enzalutamide

Outcome(s)

Primary Outcome

Radiographic Progression-Free Survival (rPFS) [ Time Frame: up to approximately 50 months ]

rPFS is defined as the time from randomisation to radiographic progression, as assessed by the investigator per RECIST 1.1 (soft tissue) and/or PCWG3 criteria (bone), or, death due to any cause.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Male 18 years of age or more

- 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 or more and/or 1 soft tissue lesion or more 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 or more 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.

Exclude criteria

- Participants with a history of MDS/AML or with features suggestive of MDS/AML

- 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 or more) 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 arrythmia 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

Related Information

• Primary Sponsor: Hibi Kazushige
• Secondary ID(s): NCT06120491