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

March 16, 2026 updated by: linqi, First Affiliated Hospital of Wenzhou Medical University

Study on the Efficacy Evaluation of First-line Standard Treatment for Metastatic Prostate Cancer Patients Using a Multimodal Prediction Model Based on PSMA-PET.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This multicenter retrospective cohort study was conducted across five tertiary hospitals in China. Patients diagnosed with metastatic hormone-sensitive prostate cancer (mHSPC) between September 2020 and May 2025 were identified from routine clinical practice. Distant metastasis was confirmed by conventional imaging and/or PSMA PET/CT. Treatment was not assigned by the study; all patients received first-line standard therapy as determined by their treating physicians.

Baseline PSMA PET/CT scans obtained before treatment initiation were analyzed to derive quantitative imaging features, including measures of whole-body tumor burden such as PSMA PET tumor volume and lesion activity-weighted metrics. These imaging variables were integrated with baseline clinical factors to develop and validate a multimodal prediction model. Model development was performed in one cohort and externally tested in an independent cohort to evaluate generalizability.

The primary endpoint was time to deep PSA response (PSA ≤ 0.2 ng/mL), defined as the time from initiation of first-line therapy to the first PSA measurement meeting this threshold. Participants without deep PSA response were censored at the date of the last available PSA measurement. Secondary endpoints included model discrimination and calibration metrics, such as time-dependent AUC and C-index, as well as model interpretability analyses.

Key eligibility criteria included confirmed mHSPC, availability of complete baseline PSMA PET/CT imaging and clinical data, and initiation of first-line standard therapy within 3 months of diagnosis. Exclusion criteria included other concurrent malignancies, receipt of other prostate cancer therapies around the time of diagnosis, non-adenocarcinoma histologies, and insufficient follow-up duration. The study used de-identified data extracted from existing records and did not require additional procedures beyond routine care.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
168

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • The First Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Multicenter retrospective cohort of male patients with metastatic hormone-sensitive prostate cancer (mHSPC) treated in routine clinical practice. Participants had baseline PSMA PET/CT prior to first-line therapy and available clinical variables and PSA follow-up for outcome assessment.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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.
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: 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.
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.
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: Darolutamide
Darolutamide 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time from initiation of first-line therapy to the first prostate-specific antigen (PSA) value ≤ 0.2 ng/mL. Participants who do not achieve PSA ≤ 0.2 ng/mL will be censored at the date of the last available PSA measurement.
From initiation of first-line therapy to the first PSA measurement ≤ 0.2 ng/mL, up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital of Wenzhou Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Second Affiliated Hospital of Wenzhou Medical University
Ningbo No. 1 Hospital
Lishui Country People's Hospital
Sun Yat-Sen University Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 3, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 3, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY2025-R087

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified individual participant data will not be shared because this is a multicenter retrospective study and the dataset contains potentially identifiable clinical and imaging information. Data sharing is restricted by institutional policies, ethics approvals, and data governance requirements. Aggregated results and de-identified summary-level data may be provided upon reasonable request where permitted.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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