Prostate CancerPSMA-DRCSINCT07887555
Integrated ¹⁸F-PSMA-1007 PET/MR Combined With Diffusion-Relaxation Correlation Spectrum Imaging for Preoperative Prediction of Postoperative Adverse Pathology and High ISUP Grade in Prostate Cancer
An observational study of Prostate Cancer, run by Ruijin Hospital at 1 site in China.
Trial summary
This retrospective observational study evaluates whether integrated ¹⁸F-PSMA-1007 PET/MR combined with diffusion-relaxation correlation spectrum imaging (DR-CSI) can help predict aggressive pathological features in patients with prostate cancer before radical prostatectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 12 Oct 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Preoperative ^18F-PSMA-1007 PET/CT and PET/MRI data were collected from patients with prostate cancer who were diagnosed and treated at our hospital between September 2023 and August 2026.
Who may be able to join
- Adult patients aged >30 years.
- Newly diagnosed, biopsy-confirmed prostate cancer with planned radical prostatectomy.
- Underwent both 18F-PSMA-1007 PET/MRI and PET/CT examinations.
- Availability of pathological results from our institution or another hospital obtained within 3 months of the imaging examination.
Who cannot join
- Previous surgical treatment or hormonal therapy for prostate cancer.
- Diagnosis of another malignancy within the preceding 1 year or ongoing treatment for another malignancy.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Nuclear Medicine & Institute for medical imaging technology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,, Shanghai, shanghai Site
Shanghai, Shanghai Municipality, 200025
About this study
This retrospective observational study evaluates whether integrated ¹⁸F-PSMA-1007 PET/MR combined with diffusion-relaxation correlation spectrum imaging (DR-CSI) can help predict aggressive pathological features in patients with prostate cancer before radical prostatectomy.
The study includes patients who underwent both ¹⁸F-PSMA-1007 PET/CT and PET/MR before surgery and had complete postoperative pathological information. Imaging features from PET/CT, conventional PET/MR, and DR-CSI are compared with clinical and pathological findings. The main aim is to determine whether PET/MR with DR-CSI can provide additional information for predicting adverse pathological findings after surgery and high postoperative ISUP grade.
This study does not assign participants to any imaging examination or treatment. All analyses are based on previously collected clinical, imaging, and pathological data.
Read the detailed description
This single-center retrospective observational study investigates the preoperative risk-stratification value of integrated ¹⁸F-PSMA-1007 PET/MR combined with diffusion-relaxation correlation spectrum imaging (DR-CSI) in patients with histologically confirmed prostate cancer who subsequently underwent radical prostatectomy.
Eligible patients underwent both preoperative ¹⁸F-PSMA-1007 PET/CT and integrated PET/MR, including conventional magnetic resonance imaging and DR-CSI. Quantitative PET parameters, conventional MRI parameters, PI-RADS assessment, and DR-CSI-derived microstructural parameters are evaluated together with available preoperative clinical information. Postoperative whole-gland pathological findings serve as the reference standard.
The study compares the predictive performance of different preoperative information strategies, including clinical variables, PET/CT imaging, PET/MR imaging, and PET/MR supplemented with DR-CSI. Particular attention is given to whether DR-CSI provides complementary microstructural information beyond conventional PET/MR and whether the integrated imaging model can approach the predictive performance of a clinical model for high postoperative ISUP grade.
Model performance is assessed using internally validated prediction methods with repeated nested cross-validation and out-of-fold predictions. Discrimination, prediction error, calibration, and decision-curve characteristics are evaluated. Because this is an exploratory single-center study without external validation, comparisons between imaging strategies are interpreted as internal exploratory evidence rather than definitive proof of clinical superiority or equivalence.
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, PSMA PET/MR, Diffusion-relaxation correlation spectrum imaging, Prediction model
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adverse pathology-positive group | Adverse pathology confirmed by postoperative histopathology | |
| Adverse pathology-negative group | Adverse pathology-negative group, confirmed by postoperative histopathology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative adverse pathology and its definition
Postoperative adverse pathology was defined as the presence of at least one of the following findings on radical prostatectomy histopathology: extraprostatic extension (EPE), seminal vesicle invasion (SVI), or positive surgical margin (PSM). Patients without any of these findings were classified as adverse pathology-negative. Lymph node involvement was not included in the composite endpoint because nodal pathological assessment was not uniformly available.
Measured: At radical prostatectomy, within approximately 1 month after preoperative imaging
Secondary outcomes (1)
Postoperative ISUP Grade ≥4
Postoperative ISUP grade was determined from the histopathological assessment of the radical prostatectomy specimen according to the International Society of Urological Pathology (ISUP) Grade Group system. Patients with postoperative ISUP Grade Group 4 or 5 were classified as having high-grade disease (ISUP ≥4), whereas those with Grade Group 1-3 were classified as ISUP <4.
Measured: Within approximately 1 month after preoperative imaging, based on histopathological assessment of the radical prostatectomy specimen.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start12 Oct 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
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 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
- Other
- Enrolment
- 300 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
- NCT07887555
- Sponsor's protocol ID
- RuijinH 2026-699
- Acronym
- PSMA-DRCSI
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated ¹⁸F-PSMA-1007 PET/MR Combined With Diffusion-Relaxation Correlation Spectrum Imaging for Preoperative Prediction of Postoperative Adverse Pathology and High ISUP Grade in Prostate Cancer
- ClinicalTrials.gov ID
- NCT07887555
- Acronym / sponsor ID
- PSMA-DRCSI / RuijinH 2026-699
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, PSMA PET/MR, Diffusion-relaxation correlation spectrum imaging, Prediction model
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 12 Oct 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Oct 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 retrospective observational study evaluates whether integrated ¹⁸F-PSMA-1007 PET/MR combined with diffusion-relaxation correlation spectrum imaging (DR-CSI) can help predict aggressive pathological features in patients with prostate cancer before radical prostatectomy.
The study includes patients who underwent both ¹⁸F-PSMA-1007 PET/CT and PET/MR before surgery and had complete postoperative pathological information. Imaging features from PET/CT, conventional PET/MR, and DR-CSI are compared with clinical and pathological findings. The main aim is to determine whether PET/MR with DR-CSI can provide additional information for predicting adverse pathological findings after surgery and high postoperative ISUP grade.
This study does not assign participants to any imaging examination or treatment. All analyses are based on previously collected clinical, imaging, and pathological data.
Detailed description
This single-center retrospective observational study investigates the preoperative risk-stratification value of integrated ¹⁸F-PSMA-1007 PET/MR combined with diffusion-relaxation correlation spectrum imaging (DR-CSI) in patients with histologically confirmed prostate cancer who subsequently underwent radical prostatectomy.
Eligible patients underwent both preoperative ¹⁸F-PSMA-1007 PET/CT and integrated PET/MR, including conventional magnetic resonance imaging and DR-CSI. Quantitative PET parameters, conventional MRI parameters, PI-RADS assessment, and DR-CSI-derived microstructural parameters are evaluated together with available preoperative clinical information. Postoperative whole-gland pathological findings serve as the reference standard.
The study compares the predictive performance of different preoperative information strategies, including clinical variables, PET/CT imaging, PET/MR imaging, and PET/MR supplemented with DR-CSI. Particular attention is given to whether DR-CSI provides complementary microstructural information beyond conventional PET/MR and whether the integrated imaging model can approach the predictive performance of a clinical model for high postoperative ISUP grade.
Model performance is assessed using internally validated prediction methods with repeated nested cross-validation and out-of-fold predictions. Discrimination, prediction error, calibration, and decision-curve characteristics are evaluated. Because this is an exploratory single-center study without external validation, comparisons between imaging strategies are interpreted as internal exploratory evidence rather than definitive proof of clinical superiority or equivalence.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adverse pathology-positive group | – | –Adverse pathology confirmed by postoperative histopathology |
| Adverse pathology-negative group | – | –Adverse pathology-negative group, confirmed by postoperative histopathology |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Preoperative ^18F-PSMA-1007 PET/CT and PET/MRI data were collected from patients with prostate cancer who were diagnosed and treated at our hospital between September 2023 and August 2026.
Key inclusion criteria (4 listed)
- Adult patients aged >30 years.
- Newly diagnosed, biopsy-confirmed prostate cancer with planned radical prostatectomy.
- Underwent both 18F-PSMA-1007 PET/MRI and PET/CT examinations.
- Availability of pathological results from our institution or another hospital obtained within 3 months of the imaging examination.
Key exclusion criteria (2 listed)
- Previous surgical treatment or hormonal therapy for prostate cancer.
- Diagnosis of another malignancy within the preceding 1 year or ongoing treatment for another malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative adverse pathology and its definition
Time frame: At radical prostatectomy, within approximately 1 month after preoperative imaging
Postoperative adverse pathology was defined as the presence of at least one of the following findings on radical prostatectomy histopathology: extraprostatic extension (EPE), seminal vesicle invasion (SVI), or positive surgical margin (PSM). Patients without any of these findings were classified as adverse pathology-negative. Lymph node involvement was not included in the composite endpoint because nodal pathological assessment was not uniformly available.
1 secondary outcome
Postoperative ISUP Grade ≥4
Time frame: Within approximately 1 month after preoperative imaging, based on histopathological assessment of the radical prostatectomy specimen.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 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, 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 4 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: under way, not looking for participants, as of the sponsor's last update on 21 Oct 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?
This study is still under way. Results are not available in the source record yet.
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?
Postoperative adverse pathology and its definition (time frame: At radical prostatectomy, within approximately 1 month after preoperative imaging). 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 21 Oct 2026.