Prostate CancerNCT06604377
Model of Predicting Biochemical Recurrence After Radical Prostate Cancer Based on Pre-treatment PSMA PET / MR Image Features
An observational study of Prostate Cancer, run by Ruijin Hospital at 1 site in China.
Trial summary
The purpose of this study is to investigate the predictive value of preoperative 18F-PSMA-1007 PET/MR in the predictive effect of biological recurrence (BCR) after radical prostatectomy (RP) for localized prostate cancer (PCa). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Observe
- How many people
- 203 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 30 Jun 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with prostate cancer undergoing PSMA PET/MR examination prior to surgery
Who may be able to join
- Age ≥ 18 years
- Histologically confirmed prostate cancer without other types of malignancy -
Who cannot join
- 1.Surgery or endocrine therapy is performed prior to the examination
- -
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine
Shanghai
About this study
The purpose of this study is to investigate the predictive value of preoperative 18F-PSMA-1007 PET/MR in the predictive effect of biological recurrence (BCR) after radical prostatectomy (RP) for localized prostate cancer (PCa).
Read the detailed description
Construct a predictive model for biochemical recurrence (BCR) in patients after radical prostatectomy using imaging parameters from preoperative 18F-PSMA-1007 PET/MRI, and compare the predictive performance of this model with existing clinical models. Data from three centers will be collected, with datasets from two centers used as the training set for the selection of predictive factors and model construction, while the dataset from the remaining center will serve as the validation set to assess the predictive performance of the model for BCR after prostatectomy.
- Conditions
- Prostate Cancer
- Being tested
- Observe
- Keywords
- PET/MR, Prostate cancer, Biochemical recurrence, Multicenter
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObserveOther
Ruijin
| Study group | Role | What they receive |
|---|---|---|
| Shanghai East Hospital, Tongji University School of Medicine | Patients diagnosed with prostate cancer undergoing PSMA PET/MR examination prior to surgery. Receives: Other: Observe |
What is being measured
The primary outcome is the main question the study is designed to answer.
18F-PSMA-1007 PET/MR image parameters
Measured: Before surgery
Secondary outcomes (1)
Biochemical recurrence-free survival time
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Nov 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu Jiajia, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604377
- Sponsor's protocol ID
- RuijinH 2024-244
- Status last verified
- Sep 2024
- First submitted
- 11 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hu J, Chunyu H, Yang Y, Song Y, Cheng C, Tang H, Chen X, Cheng R, Dai J, Meng H, Zuo C, Zhao J, Li B. Development and validation of a preoperative 18F-PSMA-1007 PET/MR prognostic model for predicting biochemical recurrence in prostate cancer: a multicentre study. Eur J Nucl Med Mol Imaging. 2026 Sep 15. doi: 10.1007/s00259-026-08179-5. Online ahead of print.
PubMed 42736457
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Model of Predicting Biochemical Recurrence After Radical Prostate Cancer Based on Pre-treatment PSMA PET / MR Image Features
- ClinicalTrials.gov ID
- NCT06604377
- Acronym / sponsor ID
- RuijinH 2024-244
- Conditions
- Prostate Cancer
- Keywords
- PET/MR, Prostate cancer, Biochemical recurrence, Multicenter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 19 Sep 2024 (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 investigate the predictive value of preoperative 18F-PSMA-1007 PET/MR in the predictive effect of biological recurrence (BCR) after radical prostatectomy (RP) for localized prostate cancer (PCa).
Detailed description
Construct a predictive model for biochemical recurrence (BCR) in patients after radical prostatectomy using imaging parameters from preoperative 18F-PSMA-1007 PET/MRI, and compare the predictive performance of this model with existing clinical models. Data from three centers will be collected, with datasets from two centers used as the training set for the selection of predictive factors and model construction, while the dataset from the remaining center will serve as the validation set to assess the predictive performance of the model for BCR after prostatectomy.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shanghai East Hospital, Tongji University School of Medicine | – | Other: ObservePatients diagnosed with prostate cancer undergoing PSMA PET/MR examination prior to surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with prostate cancer undergoing PSMA PET/MR examination prior to surgery
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Histologically confirmed prostate cancer without other types of malignancy -
Key exclusion criteria (2 listed)
- 1.Surgery or endocrine therapy is performed prior to the examination
- -
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 |
|---|---|---|
| ObserveRuijin | Other | Shanghai East Hospital, Tongji University School of Medicine |
Primary outcome
18F-PSMA-1007 PET/MR image parameters
Time frame: Before surgery
1 secondary outcome
Biochemical recurrence-free survival time
Time frame: 3 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 19 Sep 2024.
- Derived from this study: PubMed 42736457Hu J, Chunyu H, Yang Y, Song Y, Cheng C, Tang H, Chen X, Cheng R, Dai J, Meng H, Zuo C, Zhao J, Li B. Development and validation of a preoperative 18F-PSMA-1007 PET/MR prognostic model for predicting biochemical recurrence in prostate cancer: a multicentre study. Eur J Nucl Med Mol Imaging. 2026 Sep 15. doi: 10.1007/s00259-026-08179-5. Online ahead of print.
- 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, run by Ruijin Hospital 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 19 Sep 2024. 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?
18F-PSMA-1007 PET/MR image parameters (time frame: Before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06604377, which also lists 1 linked publication.
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 19 Sep 2024.