An observational study in Prostate Cancer, sponsored by Ruijin Hospital. Active, not recruiting at 1 site in China. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Ruijin Hospital · Observational
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.
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.
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
This study's enrollment of 300 is above the median of 200 across 1,200 observational studies indexed under Prostatic Neoplasms.
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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.
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Exclusion Criteria:
Adverse pathology confirmed by postoperative histopathology
\*\*Adverse pathology-negative group, confirmed by postoperative histopathology\*\*
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.
Time frame: At radical prostatectomy, within approximately 1 month after preoperative imaging
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.
Time frame: Within approximately 1 month after preoperative imaging, based on histopathological assessment of the radical prostatectomy specimen.
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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