The Prognostic Value of PET/CT for Tumor Progression in P... | NCT06915714

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

NCT06915714

Sponsor

Sun Yat-sen University

Status

Completed

Last Update Posted

Apr 8, 2025Actual

Enrollment

45Actual

Phase

Not provided

Conditions

Prostate Cancer Metastatic Disease
PET / CT

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2, 2024Actual

Primary Completion Date

Feb 20, 2025Actual

Completion Date

Feb 28, 2025Actual

First Submitted Date

Mar 22, 2025

First Submission Date that Met QC Criteria

Apr 4, 2025

First Posted Date

Apr 8, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2025

Last Update Posted Date

Apr 8, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Castration-Resistant Prostate Cancer free survival (CRPC-FS)		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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fangzheng Xiang	First affiliated hospital, Sun Yat-sen univeristy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
First affiliated hospital, Sun Yat-sen univeristy		Guangzhou	Guangdong	510080	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided