Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Hormone-Sensitive Prostate Cancer | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Androgen Deprivation Therapy | Drug | — | UNRESOLVED |
| Apalutamide | Drug | Apalutamide | ALIAS |
| Darolutamide | Drug | Darolutamide | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Enzalutamide | Drug | Enzalutamide | ALIAS |
| Rezvilutamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- ADT plus apalutamide
- description
- 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.
- interventionNames
- Drug: Androgen Deprivation Therapy
- Drug: Apalutamide
- label
- ADT plus other ARSI
- description
- 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.
- interventionNames
- Drug: Androgen Deprivation Therapy
- Drug: Enzalutamide
- Drug: Darolutamide
- Drug: Rezvilutamide
- label
- Triplet therapy (ADT + ARSI + docetaxel)
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available