European journal of nuclear medicine and molecular imaging · 2026
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.
СтатьяКлиническое исследование II фазыМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Pan Jian, Wang Beihe, Zhu Bin, Gan Hualei, Hu Xiaoxin, Liu Xiaohang, Li Xiaomeng, Wu Junlong, Wang Hongkai, Zhang Qing, Liu Chang, Song Shaoli, Ma Xuejun, Ye Dingwei, Zhu Yao
Аннотация
BACKGROUND: Metastatic hormone-sensitive prostate cancer (mHSPC) with limited metastatic burden presents a therapeutic challenge, with residual PSMA-avid disease post-androgen receptor pathway inhibitor (ARPI) treatment poorly characterized in prospective studies.
PATIENTS AND METHODS: The CHAMPION trial (NCT05717582) was a multicenter, single-arm, phase II study designed to evaluate the efficacy and safety of a response-adapted treatment strategy incorporating consolidative therapy (TCT) for PSMA-avid residual resistant clones following ARPI in newly diagnosed mHSPC patients with ≤ 10 conventional imaging (CI)-defined distant metastases from March 2023 to August 2024. PSMA PET/CT scans were performed at baseline and after three cycles of apalutamide plus castration. Patients with > 10 PSMA-positive distant metastases continued apalutamide therapy, while those with ≤ 10 metastases underwent radical prostatectomy or radiotherapy, with stereotactic body radiotherapy targeting all remaining PSMA-positive lesions, if present. The primary endpoint was the proportion of patients achieving an undetectable PSA level (≤ 0.2 ng/mL) after 6 cycles of apalutamide.
RESULTS: A total of 48 patients with a median baseline PSA level of 56.8 ng/mL were enrolled. Baseline CI revealed 1-3 distant metastases in 31 patients (64.6%) and 4-10 in 17 patients (35.4%). Baseline PSMA PET/CT showed 1-3 distant metastases in 17 patients (35.4%), 4-5 in 8 patients (16.7%), and > 5 in 23 patients (47.9%); the most common PSMA-positive sites were bone (47/48, 97.9%), regional lymph nodes (28/48, 58.3%), and distant lymph nodes (15/48, 31.3%). After 3-cycle of apalutamide, two patients with > 10 PSMA-positive metastases continued apalutamide, while the remaining 46 with ≤ 10 metastases received TCT. After six cycles, the overall undetectable PSA rate was 95.8% (46/48; 95% CI: 86.0%-98.8%), a 29.1% increase from the 66.7% (32/48) observed after three cycles. Only two patients (4.2%) experienced grade ≥ 3 rash. Post-treatment, distant lymph node metastases showed the highest response rate at 93.3% (140/150), followed by vertebral column and pelvis bone metastases at 78.5% (255/325), and other bone metastases at 50.0% (58/116), with significant differences between each metastatic site pair (p < 0.0001).
CONCLUSIONS: This novel treatment paradigm, integrating PSMA PET/CT-guided TCT for residual lesions with intensified systemic therapy, was associated with a high PSA response rate and manageable adverse event profile in newly diagnosed mHSPC patients with ≤ 10 distant metastases.
TRIAL REGISTRATION: NCT05717582. Registered: 8 February 2023.
PATIENTS AND METHODS: The CHAMPION trial (NCT05717582) was a multicenter, single-arm, phase II study designed to evaluate the efficacy and safety of a response-adapted treatment strategy incorporating consolidative therapy (TCT) for PSMA-avid residual resistant clones following ARPI in newly diagnosed mHSPC patients with ≤ 10 conventional imaging (CI)-defined distant metastases from March 2023 to August 2024. PSMA PET/CT scans were performed at baseline and after three cycles of apalutamide plus castration. Patients with > 10 PSMA-positive distant metastases continued apalutamide therapy, while those with ≤ 10 metastases underwent radical prostatectomy or radiotherapy, with stereotactic body radiotherapy targeting all remaining PSMA-positive lesions, if present. The primary endpoint was the proportion of patients achieving an undetectable PSA level (≤ 0.2 ng/mL) after 6 cycles of apalutamide.
RESULTS: A total of 48 patients with a median baseline PSA level of 56.8 ng/mL were enrolled. Baseline CI revealed 1-3 distant metastases in 31 patients (64.6%) and 4-10 in 17 patients (35.4%). Baseline PSMA PET/CT showed 1-3 distant metastases in 17 patients (35.4%), 4-5 in 8 patients (16.7%), and > 5 in 23 patients (47.9%); the most common PSMA-positive sites were bone (47/48, 97.9%), regional lymph nodes (28/48, 58.3%), and distant lymph nodes (15/48, 31.3%). After 3-cycle of apalutamide, two patients with > 10 PSMA-positive metastases continued apalutamide, while the remaining 46 with ≤ 10 metastases received TCT. After six cycles, the overall undetectable PSA rate was 95.8% (46/48; 95% CI: 86.0%-98.8%), a 29.1% increase from the 66.7% (32/48) observed after three cycles. Only two patients (4.2%) experienced grade ≥ 3 rash. Post-treatment, distant lymph node metastases showed the highest response rate at 93.3% (140/150), followed by vertebral column and pelvis bone metastases at 78.5% (255/325), and other bone metastases at 50.0% (58/116), with significant differences between each metastatic site pair (p < 0.0001).
CONCLUSIONS: This novel treatment paradigm, integrating PSMA PET/CT-guided TCT for residual lesions with intensified systemic therapy, was associated with a high PSA response rate and manageable adverse event profile in newly diagnosed mHSPC patients with ≤ 10 distant metastases.
TRIAL REGISTRATION: NCT05717582. Registered: 8 February 2023.