Model of Predicting Biochemical Recurrence After Radical Prostate Cancer Based on Pre-treatment PSMA PET / MR Image Features

September 17, 2024 updated by: Hu Jiajia, Ruijin Hospital
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

203

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with prostate cancer undergoing PSMA PET/MR examination prior to surgery

Description

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Histologically confirmed prostate cancer without other types of malignancy -

Exclusion Criteria:

1.Surgery or endocrine therapy is performed prior to the examination

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Shanghai East Hospital, Tongji University School of Medicine
Patients diagnosed with prostate cancer undergoing PSMA PET/MR examination prior to surgery.
Other: Observe
Ruijin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
18F-PSMA-1007 PET/MR image parameters
Time Frame: Before surgery
Before surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Biochemical recurrence-free survival time
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

September 11, 2024

First Submitted That Met QC Criteria

September 17, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 17, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RuijinH 2024-244

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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