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Protocol for CHAMPION study: a prospective study of maximal-cytoreductive therapies for patients with de novo metastatic hormone-sensitive prostate cancer who achieve oligopersistent metastases during systemic treatment with apalutamide plus androgen deprivation therapy

Protocol for CHAMPION study

Practical Solutions and Value

The CHAMPION study aims to assess the effectiveness of a multi-modal treatment approach for newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC) patients with a limited number of distant metastatic sites. The study focuses on the use of PSMA PET/CT-guided cytoreduction in combination with apalutamide and androgen deprivation therapy (ADT) to improve patient prognosis.

Study Details

CHAMPION (NCT05717582) is an open-label, single-arm, phase II trial enrolling mHSPC cases with ≤ 10 distant metastatic sites. Patients will receive 6 cycles of apalutamide plus ADT. Those with oligometastatic disease at PSMA PET/CT after 3 treatment cycles will undergo cytoreductive radical prostatectomy. The primary endpoint is to determine the proportion of patients with undetectable PSA, no disease progression, and no symptom deterioration after 6 cycles of treatment. Secondary endpoints include PSA response rate and safety.

Study Design

The study will utilize Fleming’s two-stage group sequential design. With one-sided α = 0.05, power = 0.80, and an assumed dropout rate of 10%, the required number of patients for analysis is 47. Enrolment commenced in May 2023.

Implications

The results of this study may provide insights into the potential benefits of a multi-modal treatment approach for mHSPC patients with oligometastases, contributing to the development of improved therapeutic strategies.

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