NCT07428642Completed
PSMA PET/CT-Based Multimodal Model for Predicting Response to First-Line Therapy in mHSPC.
Study on the Efficacy Evaluation of First-line Standard Treatment for Metastatic Prostate Cancer Patients Using a Multimodal Prediction Model Based on PSMA-PET.
Source: ClinicalTrials.gov · Last updated 18 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 168 (actual)
- First submitted
- 19 Feb 2026
- Start date
- 1 Sept 2020
- Primary completion date
- 3 Dec 2025
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical University
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT07428642
What you commit to
- Study type: Observational
- Participants enrolled: 168
- From 1 Sept 2020 to the primary completion date, 3 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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.
Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.