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

NCT07887555 | Active Not Recruiting DMC

• 1 other identifier: RuijinH 2026-699
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Prostate Cancer

Keywords

Prostate cancer; PSMA PET/MR; Diffusion-relaxation correlation spectrum imaging; Prediction model

Outcome Measures

Primary Outcomes (1)

• 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.

  At radical prostatectomy, within approximately 1 month after preoperative imaging

Secondary Outcomes (1)

• Postoperative ISUP Grade ≥4

  Within approximately 1 month after preoperative imaging, based on histopathological assessment of the radical prostatectomy specimen.

Study Arms (2)

Adverse pathology-positive group

Adverse pathology confirmed by postoperative histopathology

Adverse pathology-negative group

\*\*Adverse pathology-negative group, confirmed by postoperative histopathology\*\*

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Previous surgical treatment or hormonal therapy for prostate cancer.
• Diagnosis of another malignancy within the preceding 1 year or ongoing treatment for another malignancy.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

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, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: October 12, 2026
• First Posted: October 21, 2026
• Study Start: October 12, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)