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NCT07428642COMPLETED

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

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Key Facts

Study type
OBSERVATIONAL
Conditions
Metastatic Hormone-Sensitive Prostate Cancer, Prostate Cancer
Interventions
Androgen Deprivation Therapy, Apalutamide, Enzalutamide, Darolutamide
Enrollment
168 participants
Primary completion
Dec 2025
Study completion
Dec 2025
First posted
Feb 2026
Last updated
Mar 2026

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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Source

Open on ClinicalTrials.gov