PSMA PET/CT-Based Multimodal Model for Predicting Response to First-Line Therapy in mHSPC.
NCT07428642 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 168
Last updated 2026-03-18
Summary
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.
Conditions
Interventions
- DRUG
-
Androgen Deprivation Therapy
Androgen deprivation therapy used as part of routine first-line treatment for metastatic hormone-sensitive prostate cancer. Treatment was not assigned by the study.
- DRUG
-
Apalutamide
Apalutamide used as part of routine first-line treatment for metastatic hormone-sensitive prostate cancer. Treatment was not assigned by the study.
- DRUG
-
Enzalutamide used as part of routine first-line treatment for metastatic hormone-sensitive prostate cancer. Treatment was not assigned by the study.
- DRUG
-
Darolutamide used as part of routine first-line treatment for metastatic hormone-sensitive prostate cancer. Treatment was not assigned by the study.
- DRUG
-
Rezvilutamide
Rezvilutamide used as part of routine first-line treatment for metastatic hormone-sensitive prostate cancer. Treatment was not assigned by the study.
- DRUG
-
Docetaxel used as part of routine first-line treatment for metastatic hormone-sensitive prostate cancer. Treatment was not assigned by the study.
Sponsors & Collaborators
-
Second Affiliated Hospital of Wenzhou Medical University
collaborator OTHER -
Ningbo No. 1 Hospital
collaborator OTHER -
Lishui Country People's Hospital
collaborator OTHER -
Sun Yat-Sen University Cancer Center
collaborator OTHER -
First Affiliated Hospital of Wenzhou Medical University
lead OTHER
Eligibility
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-01
- Primary Completion
- 2025-12-03
- Completion
- 2025-12-03
Countries
- China
Study Locations
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