Prostate CancerNCT07655648
Dual-tracer PET Radiomics for Prostate Cancer Stratification
An observational study of Prostate Cancer and Gleason Score, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
This single-center retrospective study aims to develop an interpretable radiomics model based on dual-tracer PET/CT to preoperatively predict the postoperative pathological Gleason grade group in treatment-naïve prostate cancer patients. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer, Gleason Score, PET/CT
- What is being tested?
- PET/CT with Gallium-68 labeled PSMA and RM26
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 May 2026
- 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: Consecutive treatment-naïve prostate cancer patients from a single center with available pre-RP dual-tracer PET/CT, biopsy, and RP pathology data.
Who may be able to join
- Treatment-naïve prostate cancer with subsequent radical prostatectomy (RP)
- Availability of presurgical dual-tracer PET/CT images, biopsy, and RP pathology data
Who cannot join
- Unavailability of imaging or pathological data
- PET/CT performed after any prostate cancer-related treatment
- Interval between PET and biopsy > 3 months
- Interval between biopsy and RP > 1 month
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Nuclear Medicine, Xiangya Hospital, Central South University
Changsha, Hunan
About this study
Official title: Dual-tracer PET/CT Interpretable Radiomics for Pathological Classification and Prognostic Stratification of Prostate Cancer
This single-center retrospective study aims to develop an interpretable radiomics model based on dual-tracer PET/CT to preoperatively predict the postoperative pathological Gleason grade group in treatment-naïve prostate cancer patients. A machine learning-based three-class prediction model will be constructed and interpreted using SHAP. Its performance will be compared with systematic biopsy results, assessing grading accuracy and prognostic value for biochemical recurrence-free survival.
- Conditions
- Prostate Cancer, Gleason Score, PET/CT, Radiomics, Biochemical Recurrence
- Being tested
- PET/CT with Gallium-68 labeled PSMA and RM26
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT with Gallium-68 labeled PSMA and RM26Diagnostic test
Retrospective analysis of pre-prostatectomy dual-tracer PET/CT (⁶⁸Ga-PSMA and ⁶⁸Ga-RM26) imaging data.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Cohort | Treatment-naïve prostate cancer patients undergoing dual-tracer PET/CT before radical prostatectomy. Receives: Diagnostic Test: PET/CT with Gallium-68 labeled PSMA and RM26 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gleason Grade Group
Gleason Grade Group
Measured: 2020.1 --- 2023.1
Secondary outcomes (1)
Biochemical recurrence-free survival
Time from surgery to biochemical recurrence (PSA ≥ 0.2 ng/ml or initiation of salvage treatment) or last follow-up.
Measured: From surgery to biochemical recurrence or study cutoff (up to 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Jan 2020
- Primary completion1 May 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongxiang Tang, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655648
- Sponsor's protocol ID
- KY20260315
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-tracer PET/CT Interpretable Radiomics for Pathological Classification and Prognostic Stratification of Prostate Cancer
- ClinicalTrials.gov ID
- NCT07655648
- Acronym / sponsor ID
- KY20260315
- Conditions
- Prostate Cancer, Gleason Score, PET/CT, Radiomics, Biochemical Recurrence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 18 Jun 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 single-center retrospective study aims to develop an interpretable radiomics model based on dual-tracer PET/CT to preoperatively predict the postoperative pathological Gleason grade group in treatment-naïve prostate cancer patients. A machine learning-based three-class prediction model will be constructed and interpreted using SHAP. Its performance will be compared with systematic biopsy results, assessing grading accuracy and prognostic value for biochemical recurrence-free survival.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retrospective Cohort | – | Diagnostic Test: PET/CT with Gallium-68 labeled PSMA and RM26Treatment-naïve prostate cancer patients undergoing dual-tracer PET/CT before radical prostatectomy. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive treatment-naïve prostate cancer patients from a single center with available pre-RP dual-tracer PET/CT, biopsy, and RP pathology data.
Key inclusion criteria (2 listed)
- Treatment-naïve prostate cancer with subsequent radical prostatectomy (RP)
- Availability of presurgical dual-tracer PET/CT images, biopsy, and RP pathology data
Key exclusion criteria (4 listed)
- Unavailability of imaging or pathological data
- PET/CT performed after any prostate cancer-related treatment
- Interval between PET and biopsy > 3 months
- Interval between biopsy and RP > 1 month
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 |
|---|---|---|
| PET/CT with Gallium-68 labeled PSMA and RM26Retrospective analysis of pre-prostatectomy dual-tracer PET/CT (⁶⁸Ga-PSMA and ⁶⁸Ga-RM26) imaging data. | Diagnostic test | Retrospective Cohort |
Primary outcome
Gleason Grade Group
Time frame: 2020.1 --- 2023.1
Gleason Grade Group
1 secondary outcome
Biochemical recurrence-free survival
Time frame: From surgery to biochemical recurrence or study cutoff (up to 5 years)
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 Jun 2026.
- Individual participant dataSharing planned: No
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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 Prostate Cancer and Gleason Score, run by Xiangya Hospital of Central South 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 2 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 Jun 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?
Gleason Grade Group (time frame: 2020.1 --- 2023.1). 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 Jun 2026.