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

NCT07428642 | Completed

• 1 other identifier: KY2025-R087
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

Brief 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

Metastatic Hormone-Sensitive Prostate Cancer; Prostate Cancer

Keywords

mHSPC; metastatic prostate cancer; PSMA PET/CT; tumor burden; PSMA tumor volume; TL-PSMA; PSA response; first-line therapy

Outcome Measures

Primary Outcomes (1)

• Time to deep PSA response (PSA ≤ 0.2 ng/mL)

  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

Study Arms (3)

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; Drug: Apalutamide

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; Drug: Enzalutamide; Drug: Darolutamide; Drug: Rezvilutamide

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; Drug: Darolutamide; Drug: Docetaxel

Interventions

Enzalutamide DRUG

Enzalutamide 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

Darolutamide DRUG

Darolutamide 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; Triplet therapy (ADT + ARSI + docetaxel)

Rezvilutamide DRUG

Rezvilutamide 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

Docetaxel DRUG

Docetaxel 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)

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.

ADT plus apalutamide; ADT plus other ARSI; Triplet therapy (ADT + ARSI + docetaxel)

Apalutamide DRUG

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

ADT plus apalutamide

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lishui Country People's Hospital: collaborator
• Sun Yat-Sen University Cancer Center: collaborator
• First Affiliated Hospital of Wenzhou Medical University: lead
• Second Affiliated Hospital of Wenzhou Medical University: collaborator
• Ningbo No. 1 Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Androgen Antagonists; apalutamide; enzalutamide; darolutamide; Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: February 24, 2026
• Study Start: September 1, 2020
• Primary Completion: December 3, 2025
• Study Completion: December 3, 2025
• Last Updated: March 18, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)