PSMA PET/CT-Based Multimodal Model for Predicting Response to First-Line Therapy in mHSPC.

Sponsor
First Affiliated Hospital of Wenzhou Medical University
Study ID
NCT07428642
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Androgen Deprivation Therapy — DRUG
    Androgen deprivation therapy used as part of routine first-line treatment for metastatic hormone-sensitive prostate cancer. Treatment was not assigned by the study.
  • Apalutamide — DRUG
    Apalutamide used as part of routine first-line treatment for metastatic hormone-sensitive prostate cancer. Treatment was not assigned by the study.
  • Enzalutamide — DRUG
    Enzalutamide used as part of routine first-line treatment for metastatic hormone-sensitive prostate cancer. Treatment was not assigned by the study.
  • Darolutamide — DRUG
    Darolutamide used as part of routine first-line treatment for metastatic hormone-sensitive prostate cancer. Treatment was not assigned by the study.
  • Rezvilutamide — DRUG
    Rezvilutamide used as part of routine first-line treatment for metastatic hormone-sensitive prostate cancer. Treatment was not assigned by the study.
  • Docetaxel — DRUG
    Docetaxel used as part of routine first-line treatment for metastatic hormone-sensitive prostate cancer. Treatment was not assigned by the study.

Study Details

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.

Key Dates

Start date
Sep 1, 2020
Status verified
Dec 2025
Primary completion
Dec 3, 2025
Completion
Dec 3, 2025

Study Design

Enrollment
168 participants (actual)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

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 ]

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