PSMA PET/CT-Based Multimodal Model for Predicting Response to First-Line Therapy in mHSPC.
Study on the Efficacy Evaluation of First-line Standard Treatment for Metastatic Prostate Cancer Patients Using a Multimodal Prediction Model Based on PSMA-PET.
Sponsor: First Affiliated Hospital of Wenzhou Medical University + Second Affiliated Hospital of Wenzhou Medical University, Ningbo No. 1 Hospital
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Time to deep PSA response (PSA ≤ 0.2 ng/mL)
Time frame: From initiation of first-line therapy to the first PSA measurement ≤ 0.2 ng/mL, up to 36 months
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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