CHAMPION
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 ADT (CHAMPION Study)
Sponsor study identifier
interventional
47
1 country
2
Study Start
May 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
To assess the feasibility and safety of Maximal cytoreductive therapies in patients with de novo mCSPC who achieve ≤10 oligopersistent metastases on PSMA PET CT after initial 3-month systemic treatment with apalutamide plus ADT. Maximal cytoreductive therapies consist of 1.cytoreductive radical prostatectomy with/without PLND guided by post-treatment PET 2.metastasis-directed therapy with radiation guided by post-treatment oligopersistent metastases. All patients receive continuous systemic treatment with apalutamide plus ADT.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 25, 2023
Actual (reported)February 8, 2023
Actual (reported)May 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
proportion of patients with undetectable PSA level after 6 cycles of treatment (each cycle is 28 days).
It is defined as the proportion of patients with PSA≤0.2 ng/mL without disease progression or symptomatic deterioration after 6 cycles of study treatment (each cycle is 28 days).
At the end of the 6th cycle of treatment (each cycle is 28 days).
proportion of patients with undetectable PSA level after 3 cycles of treatment (each cycle is 28 days).
At the end of the 3rd cycle of treatment (each cycle is 28 days).
PSA50 response rate and PSA90 response rate at the end of the 3rd treatment cycle (each cycle is 28 days).
At the end of the 3rd cycle of treatment (each cycle is 28 days).
PSA50 response rate and PSA90 response rate at the end of the 6th treatment cycle (each cycle is 28 days).
At the end of the 6th cycle of treatment (each cycle is 28 days).
Conventional imaging and PSMA-PET/CT imaging features at baseline
Baseline (Before trial treatment)
Proportion of patients with ≤ 10 metastases on PSMA-PET/CT imaging at the end of the third treatment cycle (each cycle is 28 days).
At the end of the 3rd cycle of treatment (each cycle is 28 days).
Patients with de novo mCSPC who achieve ≤10 oligopersistent metastases on PSMA PET CT after initial 3-month systemic treatment with apalutamide plus ADT will receive cytoreductive radical prostatectomy with/without PLND and metastasis-directed therapy with radiation.
Patients receive apalutamide 240mg,qd,po.
Patients receive systemic ADT.
Fudan University Shanghai Cancer Center Pudong Hospital
Shanghai, Shanghai Municipality, 200000, China
Fudan University Shanghai Cancer Center Xuhui Hospital
Shanghai, Shanghai Municipality, 200000, China
Pan J, Wang B, Zhu B, Gan H, Hu X, Liu X, Li X, Wu J, Wang H, Zhang Q, Liu C, Song S, Ma X, Ye D, Zhu Y. Consolidative therapy for PSMA-avid lesions after 3 cycles of apalutamide plus androgen deprivation in metastatic hormone-sensitive prostate cancer: A prospective phase 2 single-arm trial. Eur J Nucl Med Mol Imaging. 2026 Jun 8. doi: 10.1007/s00259-026-07982-4. Online ahead of print.
Wang B, Pan J, Zhang T, Ni X, Wei Y, Li X, Fang B, Hu X, Gan H, Wu J, Wang H, Ye D, Zhu Y. 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.
First Submitted
January 25, 2023
First Posted
February 8, 2023
Study Start
May 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2025
Patients receive cytoreductive radical prostatectomy with/without pelvic lymph node dissection.
Patients receive metastasis-directed therapy with radiation guided by post-treatment oligopersistent metastases.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 8, 2023
Record last verified: 2023-02
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Source: ClinicalTrials.gov.
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