Study on the Efficacy Evaluation of First-line Standard Treatment for Metastatic Prostate Cancer Patients Using a Multimodal Prediction Model Based on PSMA-PET.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Time to deep PSA response (PSA ≤ 0.2 ng/mL)
研究概览
简要总结
This multicenter retrospective study developed and validated a prediction model based on PSMA PET/CT and routine clinical information to estimate early treatment response in patients with metastatic hormone-sensitive prostate cancer (mHSPC) receiving first-line standard therapy. Existing PSMA PET/CT scans were used to quantify tumor burden, and imaging metrics were combined with baseline clinical factors, including laboratory results and disease characteristics, to build an interpretable model for predicting the likelihood and timing of achieving a deep PSA response (PSA ≤ 0.2 ng/mL) after initiation of first-line treatment.
All data were collected from medical records and imaging obtained as part of routine care; no additional tests or treatments were required. The objective was to improve risk stratification and support individualized follow-up and treatment planning for patients with mHSPC.
详细描述
This multicenter retrospective cohort study was conducted across five tertiary hospitals in China. Patients diagnosed with metastatic hormone-sensitive prostate cancer (mHSPC) between September 2020 and May 2025 were identified from routine clinical practice. Distant metastasis was confirmed by conventional imaging and/or PSMA PET/CT. Treatment was not assigned by the study; all patients received first-line standard therapy as determined by their treating physicians.
Baseline PSMA PET/CT scans obtained before treatment initiation were analyzed to derive quantitative imaging features, including measures of whole-body tumor burden such as PSMA PET tumor volume and lesion activity-weighted metrics. These imaging variables were integrated with baseline clinical factors to develop and validate a multimodal prediction model. Model development was performed in one cohort and externally tested in an independent cohort to evaluate generalizability.
The primary endpoint was time to deep PSA response (PSA ≤ 0.2 ng/mL), defined as the time from initiation of first-line therapy to the first PSA measurement meeting this threshold. Participants without deep PSA response were censored at the date of the last available PSA measurement. Secondary endpoints included model discrimination and calibration metrics, such as time-dependent AUC and C-index, as well as model interpretability analyses.
Key eligibility criteria included confirmed mHSPC, availability of complete baseline PSMA PET/CT imaging and clinical data, and initiation of first-line standard therapy within 3 months of diagnosis. Exclusion criteria included other concurrent malignancies, receipt of other prostate cancer therapies around the time of diagnosis, non-adenocarcinoma histologies, and insufficient follow-up duration. The study used de-identified data extracted from existing records and did not require additional procedures beyond routine care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients diagnosed with metastatic hormone-sensitive prostate cancer (mHSPC).
- •Distant metastasis confirmed by conventional imaging and/or PSMA PET/CT.
- •Received first-line standard therapy based on androgen deprivation therapy (ADT) with an androgen receptor signaling inhibitor (ARSI), with or without docetaxel, as part of routine clinical care.
- •Baseline PSMA PET/CT performed prior to initiation of first-line therapy.
- •Availability of required baseline clinical data and PSA follow-up data.
排除标准
- •History of or concurrent other primary malignancies.
- •Non-adenocarcinoma prostate cancer histology (e.g., neuroendocrine tumors).
- •Received prostate cancer therapies not consistent with the protocol-defined first-line setting around diagnosis (e.g., surgery, radiotherapy, chemotherapy other than protocol-defined docetaxel, targeted therapy, immunotherapy).
- •Follow-up duration < 3 months after treatment initiation.
研究组 & 干预措施
ADT plus apalutamide
Combination regimen of androgen deprivation therapy (ADT) and apalutamide used as part of routine first-line standard therapy for mHSPC. Treatment was not assigned by the study.
干预措施: Androgen Deprivation Therapy (Drug)
ADT plus apalutamide
Combination regimen of androgen deprivation therapy (ADT) and apalutamide used as part of routine first-line standard therapy for mHSPC. Treatment was not assigned by the study.
干预措施: Apalutamide (Drug)
ADT plus other ARSI
Combination regimen of ADT and an androgen receptor signaling inhibitor (ARSI) other than apalutamide (e.g., enzalutamide, darolutamide, or rezvilutamide) used as part of routine first-line standard therapy for mHSPC. Treatment was not assigned by the study.
干预措施: Androgen Deprivation Therapy (Drug)
ADT plus other ARSI
Combination regimen of ADT and an androgen receptor signaling inhibitor (ARSI) other than apalutamide (e.g., enzalutamide, darolutamide, or rezvilutamide) used as part of routine first-line standard therapy for mHSPC. Treatment was not assigned by the study.
干预措施: Enzalutamide (Drug)
ADT plus other ARSI
Combination regimen of ADT and an androgen receptor signaling inhibitor (ARSI) other than apalutamide (e.g., enzalutamide, darolutamide, or rezvilutamide) used as part of routine first-line standard therapy for mHSPC. Treatment was not assigned by the study.
干预措施: Darolutamide (Drug)
ADT plus other ARSI
Combination regimen of ADT and an androgen receptor signaling inhibitor (ARSI) other than apalutamide (e.g., enzalutamide, darolutamide, or rezvilutamide) used as part of routine first-line standard therapy for mHSPC. Treatment was not assigned by the study.
干预措施: Rezvilutamide (Drug)
Triplet therapy (ADT + ARSI + docetaxel)
Triplet regimen consisting of androgen deprivation therapy (ADT), an androgen receptor signaling inhibitor (ARSI), and docetaxel used as part of routine first-line standard therapy for mHSPC. Treatment was not assigned by the study.
干预措施: Androgen Deprivation Therapy (Drug)
Triplet therapy (ADT + ARSI + docetaxel)
Triplet regimen consisting of androgen deprivation therapy (ADT), an androgen receptor signaling inhibitor (ARSI), and docetaxel used as part of routine first-line standard therapy for mHSPC. Treatment was not assigned by the study.
干预措施: Darolutamide (Drug)
Triplet therapy (ADT + ARSI + docetaxel)
Triplet regimen consisting of androgen deprivation therapy (ADT), an androgen receptor signaling inhibitor (ARSI), and docetaxel used as part of routine first-line standard therapy for mHSPC. Treatment was not assigned by the study.
干预措施: Docetaxel (Drug)
结局指标
主要结局
Time to deep PSA response (PSA ≤ 0.2 ng/mL)
时间窗: From initiation of first-line therapy to the first PSA measurement ≤ 0.2 ng/mL, up to 36 months
Time from initiation of first-line therapy to the first prostate-specific antigen (PSA) value ≤ 0.2 ng/mL. Participants who do not achieve PSA ≤ 0.2 ng/mL will be censored at the date of the last available PSA measurement.
次要结局
未报告次要终点
研究者
linqi
Principal Investigator
First Affiliated Hospital of Wenzhou Medical University