A PHASE III DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED STUDY ASSESSING THE EFFICACY AND SAFETY OF CAPIVASERTIB + ABIRATERONE VERSUS PLACEBO + ABIRATERONE AS TREATMENT FOR PATIENTS WITH DE NOVO METASTATIC HORMONE-SENSITIVE PROSTATE CANCER (MHSPC) CHARACTERISED BY PTEN DEFICIENCY (CAPITELLO-281)

Not Applicable

Recruiting

• Conditions: -C61 Malignant neoplasm of prostate; Malignant neoplasm of prostate; C61

• Registration Number: PER-049-20
• Lead Sponsor: AstraZeneca AB,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-28
• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1 Participant must be ≥ 18 years of age (≥ 20 years of age in Japan), at the time of signing the informed consent.
Type of Participant and Disease Characteristics
2 Histologically-confirmed de novo (ie, diagnosed within 3 months of randomisation) metastatic hormone-sensitive prostate adenocarcinoma. Note: adenocarcinoma must be the primary histological pattern and patients with small-cell tumours are not eligible.
3 Consent to provide a FFPE tissue block (preferred) or slides. Details on tissue requirements are specified in the Laboratory Manual. Cytologic or FNA samples are not acceptable. Tumour tissue from bone metastases is not acceptable.
4 A valid PTEN IHC result indicating PTEN deficiency (centralised testing).
5 Metastatic disease documented prior to randomisation by clear evidence of ≥ 1 bone lesion (defined as 1 lesion with positive uptake on bone scan) and/or ≥ 1 soft tissue lesion (measurable and/or non-measurable) that can be accurately assessed at baseline and is suitable for repeated assessment with CT and/or MRI. Patients with metastatic disease identified by PSMA PET only, will not be eligible. Local lymph node involvement is not considered metastatic disease.

Exclusion Criteria

1 Radiotherapy with a wide field of radiation (eg, more than one-third of the skeleton) within 4 weeks before the start of study treatment (capivasertib/placebo).
2 Major surgery (excluding placement of vascular access, transurethral resection of prostate, bilateral orchiectomy, or internal stents) within 4 weeks of the start of study treatment.
3 Brain metastases, or spinal cord compression (unless spinal cord compression is asymptomatic, treated and stable and not requiring steroids for at least 4 weeks prior to start of study treatment).
4 Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:rPFS is defined as the time from randomisation to: 1) radiographic progression, as assessed by the investigator per RECIST version 1.1 (soft tissue) and/or PCWG3 criteria (bone), or 2) death due to any cause.<br>Measure:To compare the effect of capivasertib + abiraterone relative to placebo + abiraterone by assessment of radiographic progression-free survival (rPFS) in patients with PTEN-deficient mHSPC.<br>Timepoints:Since randomization till progression of disease.<br>