The Prognostic Value of PET/CT for Tumor Progression in Patients With Metastatic Hormone-sensitive Prostate Cancer

April 4, 2025 updated by: Zheng fufu, Sun Yat-sen University

The Prognostic Value of Quantitative Parameters Derived From Dual Scanning of FDG and PSMA PET/CT for Tumor Progression in Patients With Metastatic Hormone-sensitive Prostate Cancer Receiving Novel Hormone Therapy

Investigators retrospectively collected data from consecutive patients treated at the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China, from October 2020 to March 2024. The inclusion criteria were as follows: (1) patients with diagnosis of metastatic hormone-sensitive prostate cancer, confirmed by PSA levels, radiographic tests and pathological information; (2) patients who underwent FDG and PSMA PET/CT prior to the initiation of medical treatment. The exclusion criteria were as follows: (1) patients who received novel hormone therapy or a prostate biopsy prior to PET/CT; (2) patients with other malignancies; (3) patients received hormone therapy without NHT; (4) patients received chemotherapy or radiotherapy prior to or during novel hormone therapy; (5) absence of follow-up data at the hospital.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

45

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
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • First affiliated hospital, Sun Yat-sen univeristy

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All the enrolled patients were Asian(we are a affiliated hospital of a university based in Mainland china ).

Description

Inclusion Criteria:

  • patients with diagnosis of metastatic hormone-sensitive prostate cancer, confirmed by PSA levels, radiographic tests and pathological information
  • patients who underwent FDG and PSMA PET/CT prior to the initiation of medical treatment

Exclusion Criteria:

  • patients who received novel hormone therapy or a prostate biopsy prior to PET/CT
  • patients with other malignancies
  • patients received hormone therapy without novel hormone therapy
  • patients received chemotherapy or radiotherapy prior to or during novel hormone therapy
  • absence of follow-up data at our institution

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
Group1
PCa40%MTV-P = High, PCa40%MTV-G = Low
Group2
PCa40%MTV-P = Low, PCa40%MTV-G = High
Group3
PCa40%MTV-P = Low, PCa40%MTV-G = Low
Group4
PCa40%MTV-P = High, PCa40%MTV-G = High

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Castration-Resistant Prostate Cancer free survival (CRPC-FS)
Time Frame: From date of the initiation of novel hormone therapy until the date of first documented either PSA or radiography-confirmed progression or date of the last follow-up for any cause, whichever came first, assessed up to 100 months
From date of the initiation of novel hormone therapy until the date of first documented either PSA or radiography-confirmed progression or date of the last follow-up for any cause, whichever came first, assessed up to 100 months

Collaborators and Investigators

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

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Fangzheng Xiang, First affiliated hospital, Sun Yat-sen univeristy

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)

June 2, 2024

Primary Completion (Actual)

February 20, 2025

Study Completion (Actual)

February 28, 2025

Study Registration Dates

First Submitted

March 22, 2025

First Submitted That Met QC Criteria

April 4, 2025

First Posted (Actual)

April 8, 2025

Study Record Updates

Last Update Posted (Actual)

April 8, 2025

Last Update Submitted That Met QC Criteria

April 4, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT-2025-117

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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