Multi-Modal Imaging and Digital Pathology to Predict Clinically Significant Prostate Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter observational study using preoperative mpMRI, TRUS, and postoperative digital pathology to train and validate a transformer-based deep learning model. The model aims to align imaging and pathology data through biomechanically constrained spatial registration and to predict clinically significant prostate cancer while enabling risk stratification. Internal cross-validation, external verification, and public datasets will be used to assess performance, with analyses like decision curve and clinical impact curves to gauge real-world usefulness. The goal is to support more precise biopsy decisions and avoid unnecessary procedures while improving early diagnosis and treatment planning.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subjects who are scheduled to undergo or have undergone prostate biopsy or radical prostatectomy.
2. Subjects who have completed standard-of-care preoperative multiparametric MRI (mpMRI) and transrectal ultrasound (TRUS) examinations.
3. Subjects with complete pathological diagnosis results available.
4. Age between 40 and 90 years.
5. Able and willing to provide written informed consent (for prospective cohort participants only).

Exclusion Criteria:

1. Prior history of pelvic radiation therapy or radical prostatectomy.
2. Incomplete or poor-quality mpMRI or TRUS images (e.g., motion artifacts, insufficient sequences).
3. Concurrent other primary malignant tumors.
4. Severe systemic diseases that may affect the evaluation of the prostate.
5. Subjects with incomplete clinical or pathological data.
6. Contraindications to MRI examination (e.g., incompatible metallic implants, severe claustrophobia).

Where it's running

• Liuzhou People's Hospital Affiliated to Guangxi Medical University
  Liuzhou, Guangxi, China Recruiting

Study contacts

• Principal investigator: Fubo Wang, MD — Guangxi Medical University
• Study coordinator: Caigou Shi, MD
• Email: shicaigou@sr.gxmu.edu.cn
• Phone: +86 13677729003

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• 68Ga-XMFH01 PET/FL imaging to guide prostate cancer surgery

  This study tests a new dual-modality imaging probe, 68Ga-XMFH01, to preoperatively detect prostate cancer and guide the surgeon with fluorescence during operations in adults with newly diagnosed prostate cancer.

  Recruiting The First Affiliated Hospital of Xiamen University · Xiamen, Fujian · NCT07885423

• Hugo Robotic Prostatectomy in an Ambulatory Surgery Center

  This study tests the use of the Hugo robotic system for prostate removal in adult men treated at an outpatient surgical center.

  Recruiting Central Ohio Urology Group · Columbus, Ohio · NCT07875192

• Adaptive intraoperative biopsy system for prostate cancer using imaging and metabolic feedback

  Aiming to test a smart biopsy approach that combines preoperative imaging with real-time metabolic signals to guide where to take prostate biopsy cores for better precision in men suspected of prostate cancer.

  Recruiting at 4 sites Shanghai Zhongshan Hospital · Shanghai and 3 other locations · NCT07856017

• miRNA panel test to help diagnose prostate cancer

  A blood test using a microRNA panel is being tested to help diagnose prostate cancer in men who are suspected of having the disease.

  Recruiting RenJi Hospital · Shanghai · NCT07755592

• Transperineal vs Transrectal Cognitive Fusion Biopsy for Prostate Cancer

  This study tests whether a transperineal cognitive fusion biopsy works as well as the traditional transrectal approach for detecting clinically significant prostate cancer in men with suspicious mpMRI findings.

  Recruiting Ankara Etlik City Hospital · Ankara, Yenimahalle · NCT07710807

• Testing 68Ga-NYM032 PET/CT in men with newly diagnosed prostate cancer

  This study tests a new PSMA-targeted PET/CT imaging agent to see if it safely and accurately locates cancer in men who have just been diagnosed with prostate cancer and are planned for surgery.

  Recruiting at 2 sites Phase 3 Norroy Bioscience Co., LTD · Nanjing, Jiangsu and 1 other locations · NCT07615101

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.