KEY TAKEAWAYS
- The CHAMPION phase 2 trial aimed to assess the feasibility of PSMA PET/CT-guided cytoreduction plus apalutamide and ADT for oligometastatic mHSPC.
- The primary endpoint is the proportion of patients achieving undetectable PSA, no disease progression, and stable symptoms.
- The study suggests that multi-modal therapy, tailored to treatment response, may enhance the prognosis of individuals newly diagnosed with mHSPC and oligometastases.
Beihe Wang and the team aimed to assess the feasibility of PSMA PET/CT-guided cytoreduction plus apalutamide and ADT for individuals newly diagnosed with metastatic hormone-sensitive prostate cancer (mHSPC) at an oligometastatic state.
The CHAMPION trial (NCT05717582) is an open-label, single-arm, phase II study designed to enroll individuals newly diagnosed with mHSPC and oligometastases (≤ 10 distant metastatic sites on conventional imaging). Participants will undergo 6 cycles of apalutamide plus androgen deprivation therapy (ADT).
For those with oligometastatic disease confirmed on PSMA PET/CT after 3 treatment cycles, cytoreductive radical prostatectomy will be performed. Investigators will determine the metastasis-directed external radiation therapy guided by PSMA PET/CT. Apalutamide plus ADT will be continued for 2 weeks postoperatively.
The primary endpoint will assess the proportion of individuals achieving undetectable prostate-specific antigen (PSA) with no disease progression or symptom deterioration after completing 6 cycles of apalutamide plus ADT. Secondary endpoints will include the percentage of participants with PSA levels ≤ 0.2 ng/mL and oligometastases at the end of 3 treatment cycles, PSA response rate, and safety.
The study will employ Fleming’s two-stage group sequential design, with enrollment beginning in May 2023. The null hypothesis posits that the rate of individuals with undetectable PSA after 6 treatment cycles is ≤ 40%, while the alternate hypothesis suggests an undetectable PSA of > 60%. With one-sided α = 0.05, power = 0.80, and an assumed dropout rate of 10%, the study aims to enroll 47 participants for effective analysis.
The study suggests that multimodal therapy tailored to treatment response may improve the prognosis for individuals newly diagnosed with mHSPC and oligometastases.
The trial was sponsored by the Fudan University.
Source: https://pubmed.ncbi.nlm.nih.gov/38796422/
Clinical Trial: https://clinicaltrials.gov/study/NCT05717582
Wang B, Pan J, Zhang T, et al. (2024). “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.” BMC Cancer. 2024 May 25;24(1):643. doi: 10.1186/s12885-024-12395-3. PMID: 38796422.
