Prostate Cancer (Diagnosis)NCT06919159
Intratumoral Heterogeneity on [18F]PSMA and [18F]FDG PET/CT in Predicting Invasion and Prognosis of Prostate Cancer
An observational study of Prostate Cancer (Diagnosis) and Prostate-specific Membrane Antigen, run by Jiequn Yu at 1 site in China.
Trial summary
The purpose of this study is to analyze heterogeneity of prostate cancer（PCa）based on the head-to-head imaging of prostate-specific membrane antigen (PSMA) and fluorodeoxyglucose (FDG) positron emission tomography computed tomography (PET/CT) Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer (Diagnosis), Prostate-specific Membrane Antigen, Positron Emission Tomography (PET)
- What is being tested?
- PSMA PET/CT scan and FDG-PET
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 30 Nov 2022
- 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 18 years and older
- Men only
- Adult, Older adult
Study population: Subjects treated at the First Affiliated Hospital of China Medical University
Who may be able to join
- Untreated patients with PCa confirmed by prostate systemic pathological biopsy
- Patients underwent [18F]PSMA-1007 and [18F]FDG PET/CT and the imaging interval was less than one month.
Who cannot join
- Patients received treatment at intervals of two imaging
- Imaging was less than 1 week after pathology biopsy
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Nuclear Medicine, The First Hospital of China Medical University
Shenyang, Liaoning, 110001
About this study
Official title: Intratumoral Heterogeneity on [18F]PSMA-1007 and [18F]FDG PET/CT in Predicting Invasion and Prognosis of Primary Prostate Cancer
The purpose of this study is to analyze heterogeneity of prostate cancer（PCa）based on the head-to-head imaging of prostate-specific membrane antigen (PSMA) and fluorodeoxyglucose (FDG) positron emission tomography computed tomography (PET/CT)
Read the detailed description
PET/CT examinations were performed on different days using Siemens Biograph MCT PET/CT equipment. All patients were examined on the same scanner. Patients were fasted for more than 6 h before [18F]FDG PET/CT examination, blood glucose was controlled below 11.1 mmol/L, [18F]FDG injection dose was 3.7 MBq/kg, and [18F]FDG PET/CT examination was performed after 60 min rest. [18F]PSMA-1007 injection dose was 3.7 MBq/kg, and PET/CT scan was performed 60 min after injection. To avoid interference of prostate lesion detection by active urine in the bladder, patients were asked to urinate or undergo forced diuresis before the start of the examination. The scan was performed from the top of the head to the base of the thighs. Low-dose CT was taken with automatic milliampere-second 120 kV voltage scans with a matrix of 512 × 512 and a thickness of 5 mm, and PET/CT image acquisition was taken from 5-6 beds for 2-3 min each. CT data was used for attenuation correction at the end of the acquisition, reconstructed by the two-iteration method (21 subsets in total), and the True X +TOF algorithm was applied to reconstruct the images. Two nuclear medicine physicians with extensive experience in PET/CT interpretation evaluated the images using the LIFEx software v 7.1.0. Both readers were blinded to both clinical and pathological data
- Conditions
- Prostate Cancer (Diagnosis), Prostate-specific Membrane Antigen, Positron Emission Tomography (PET)
- Being tested
- PSMA PET/CT scan, FDG-PET
- Keywords
- Fluorine-18-fluorodeoxyglucose, Heterogeneity
- Medical subject headings
- Prostatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSMA PET/CT scanDiagnostic test
Different developing agents
FDG-PETDiagnostic test
Different developing agents
| Study group | Role | What they receive |
|---|---|---|
| double positive group | patients with one type of PSMA+/FDG+ homogeneous segment Receives: Diagnostic Test: PSMA PET/CT scan; Diagnostic Test: FDG-PET | |
| double negative group | patients with one type of PSMA-/FDG- homogeneous segment Receives: Diagnostic Test: PSMA PET/CT scan; Diagnostic Test: FDG-PET | |
| PSMA predominant group | patients with one type of PSMA+/FDG- heterogeneous segment Receives: Diagnostic Test: PSMA PET/CT scan; Diagnostic Test: FDG-PET | |
| FDG predominant group | patients with one type of PSMA-/FDG+ heterogeneous segment Receives: Diagnostic Test: PSMA PET/CT scan; Diagnostic Test: FDG-PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relationship between imaging phenotypes and gleason score (GS)
Measured: From enrollment to the end of 1 month inspection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 Jul 2021
- Primary completion20 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Diagnosis)Studies 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
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiequn Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jiequn Yu, First Hospital of China Medical University
- Investigators
- Xuena Li, PhD, Study director, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919159
- Sponsor's protocol ID
- [2020]388
- Status last verified
- Apr 2025
- First submitted
- 2 Apr 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intratumoral Heterogeneity on [18F]PSMA-1007 and [18F]FDG PET/CT in Predicting Invasion and Prognosis of Primary Prostate Cancer
- ClinicalTrials.gov ID
- NCT06919159
- Acronym / sponsor ID
- [2020]388
- Conditions
- Prostate Cancer (Diagnosis), Prostate-specific Membrane Antigen, Positron Emission Tomography (PET)
- Keywords
- Fluorine-18-fluorodeoxyglucose, Heterogeneity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Jiequn YuUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 20 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 9 Apr 2025 (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.
The purpose of this study is to analyze heterogeneity of prostate cancer（PCa）based on the head-to-head imaging of prostate-specific membrane antigen (PSMA) and fluorodeoxyglucose (FDG) positron emission tomography computed tomography (PET/CT)
Detailed description
PET/CT examinations were performed on different days using Siemens Biograph MCT PET/CT equipment. All patients were examined on the same scanner. Patients were fasted for more than 6 h before [18F]FDG PET/CT examination, blood glucose was controlled below 11.1 mmol/L, [18F]FDG injection dose was 3.7 MBq/kg, and [18F]FDG PET/CT examination was performed after 60 min rest. [18F]PSMA-1007 injection dose was 3.7 MBq/kg, and PET/CT scan was performed 60 min after injection. To avoid interference of prostate lesion detection by active urine in the bladder, patients were asked to urinate or undergo forced diuresis before the start of the examination. The scan was performed from the top of the head to the base of the thighs. Low-dose CT was taken with automatic milliampere-second 120 kV voltage scans with a matrix of 512 × 512 and a thickness of 5 mm, and PET/CT image acquisition was taken from 5-6 beds for 2-3 min each. CT data was used for attenuation correction at the end of the acquisition, reconstructed by the two-iteration method (21 subsets in total), and the True X +TOF algorithm was applied to reconstruct the images. Two nuclear medicine physicians with extensive experience in PET/CT interpretation evaluated the images using the LIFEx software v 7.1.0. Both readers were blinded to both clinical and pathological data
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| double positive group | – | Diagnostic Test: PSMA PET/CT scan, Diagnostic Test: FDG-PETpatients with one type of PSMA+/FDG+ homogeneous segment |
| double negative group | – | Diagnostic Test: PSMA PET/CT scan, Diagnostic Test: FDG-PETpatients with one type of PSMA-/FDG- homogeneous segment |
| PSMA predominant group | – | Diagnostic Test: PSMA PET/CT scan, Diagnostic Test: FDG-PETpatients with one type of PSMA+/FDG- heterogeneous segment |
| FDG predominant group | – | Diagnostic Test: PSMA PET/CT scan, Diagnostic Test: FDG-PETpatients with one type of PSMA-/FDG+ heterogeneous segment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Subjects treated at the First Affiliated Hospital of China Medical University
Key inclusion criteria (2 listed)
- Untreated patients with PCa confirmed by prostate systemic pathological biopsy
- Patients underwent [18F]PSMA-1007 and [18F]FDG PET/CT and the imaging interval was less than one month.
Key exclusion criteria (2 listed)
- Patients received treatment at intervals of two imaging
- Imaging was less than 1 week after pathology biopsy
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 |
|---|---|---|
| PSMA PET/CT scanDifferent developing agents | Diagnostic test | FDG predominant group, PSMA predominant group, double negative group, double positive group |
| FDG-PETDifferent developing agents | Diagnostic test | FDG predominant group, PSMA predominant group, double negative group, double positive group |
Primary outcome
The relationship between imaging phenotypes and gleason score (GS)
Time frame: From enrollment to the end of 1 month inspection
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 11 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
Xuena Li, PhD study director
First Hospital of China Medical University
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 (Diagnosis) and Prostate-specific Membrane Antigen, run by Jiequn Yu 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 2 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 11 Apr 2025. 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?
The relationship between imaging phenotypes and gleason score (GS) (time frame: From enrollment to the end of 1 month inspection). 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 11 Apr 2025.