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

No results posted yet for this study

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

Enzalutamide used as part of routine first-line treatment for metastatic hormone-sensitive prostate cancer. Treatment was not assigned by the study.

DRUG

Darolutamide

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07428642 on ClinicalTrials.gov