Metastatic Hormone-Sensitive Prostate CancerNCT07428642
PSMA PET/CT-Based Multimodal Model for Predicting Response to First-Line Therapy in mHSPC.
An observational study of Metastatic Hormone-Sensitive Prostate Cancer and Prostate Cancer, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Metastatic Hormone-Sensitive Prostate Cancer, Prostate Cancer
- What is being tested?
- Androgen Deprivation Therapy, Apalutamide and Enzalutamide
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 3 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
About this study
Official title: 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.
Read the 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.
- Being tested
- Androgen Deprivation Therapy, Apalutamide, Enzalutamide, Darolutamide, Rezvilutamide
- Keywords
- mHSPC, metastatic prostate cancer, PSMA PET/CT, tumor burden, PSMA tumor volume, TL-PSMA, PSA response, first-line therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Androgen Deprivation TherapyDrug
Androgen deprivation therapy used as part of routine first-line treatment for metastatic hormone-sensitive prostate cancer. Treatment was not assigned by the study.
ApalutamideDrug
Apalutamide used as part of routine first-line treatment for metastatic hormone-sensitive prostate cancer. Treatment was not assigned by the study.
EnzalutamideDrug
Enzalutamide used as part of routine first-line treatment for metastatic hormone-sensitive prostate cancer. Treatment was not assigned by the study.
DarolutamideDrug
Darolutamide used as part of routine first-line treatment for metastatic hormone-sensitive prostate cancer. Treatment was not assigned by the study.
RezvilutamideDrug
Rezvilutamide used as part of routine first-line treatment for metastatic hormone-sensitive prostate cancer. Treatment was not assigned by the study.
DocetaxelDrug
Docetaxel used as part of routine first-line treatment for metastatic hormone-sensitive prostate cancer. Treatment was not assigned by the study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Androgen Deprivation Therapy; Drug: Darolutamide; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From initiation of first-line therapy to the first PSA measurement ≤ 0.2 ng/mL, up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 Sep 2020
- Primary completion3 Dec 2025
- Study completion3 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Hormone-Sensitive Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital of Wenzhou Medical University, Ningbo No. 1 Hospital, Lishui Country People's Hospital, Sun Yat-Sen University Cancer Center
- Responsible party
- Principal investigator, linqi, First Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428642
- Sponsor's protocol ID
- KY2025-R087
- Status last verified
- Dec 2025
- First submitted
- 19 Feb 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy Evaluation of First-line Standard Treatment for Metastatic Prostate Cancer Patients Using a Multimodal Prediction Model Based on PSMA-PET.
- ClinicalTrials.gov ID
- NCT07428642
- Acronym / sponsor ID
- KY2025-R087
- Keywords
- mHSPC, metastatic prostate cancer, PSMA PET/CT, tumor burden, PSMA tumor volume, TL-PSMA, PSA response, first-line therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital of Wenzhou Medical University, Ningbo No. 1 Hospital, Lishui Country People's Hospital, Sun Yat-Sen University Cancer Center
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 3 Dec 2025 (actual)
- Study completion
- 3 Dec 2025 (actual)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ADT plus apalutamide | – | Drug: Androgen Deprivation Therapy, Drug: ApalutamideCombination 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. |
| ADT plus other ARSI | – | Drug: Androgen Deprivation Therapy, Drug: Enzalutamide, Drug: Darolutamide, Drug: RezvilutamideCombination 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. |
| Triplet therapy (ADT + ARSI + docetaxel) | – | Drug: Androgen Deprivation Therapy, Drug: Darolutamide, Drug: DocetaxelTriplet 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. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Androgen Deprivation TherapyAndrogen deprivation therapy used as part of routine first-line treatment for metastatic hormone-sensitive prostate cancer. Treatment was not assigned by the study. | Drug | ADT plus apalutamide, ADT plus other ARSI, Triplet therapy (ADT + ARSI + docetaxel) |
| ApalutamideApalutamide used as part of routine first-line treatment for metastatic hormone-sensitive prostate cancer. Treatment was not assigned by the study. | Drug | ADT plus apalutamide |
| EnzalutamideEnzalutamide used as part of routine first-line treatment for metastatic hormone-sensitive prostate cancer. Treatment was not assigned by the study. | Drug | ADT plus other ARSI |
| DarolutamideDarolutamide used as part of routine first-line treatment for metastatic hormone-sensitive prostate cancer. Treatment was not assigned by the study. | Drug | ADT plus other ARSI, Triplet therapy (ADT + ARSI + docetaxel) |
| RezvilutamideRezvilutamide used as part of routine first-line treatment for metastatic hormone-sensitive prostate cancer. Treatment was not assigned by the study. | Drug | ADT plus other ARSI |
| DocetaxelDocetaxel used as part of routine first-line treatment for metastatic hormone-sensitive prostate cancer. Treatment was not assigned by the study. | Drug | Triplet therapy (ADT + ARSI + docetaxel) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Hormone-Sensitive Prostate Cancer and Prostate Cancer, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.