Osteosclerotic Changes on CT Predict Survival in Prostate... | NCT06883474

Studies
Osteosclerotic Changes on CT Predict Survival in Prostate Cancer

NCT06883474

Sponsor

Sun Yat-sen University

Status

Completed

Last Update Posted

Mar 21, 2025Actual

Enrollment

211Actual

Phase

Not provided

Conditions

Prostate Cancer (Adenocarcinoma)
Prostate Cancer Metastatic Disease

Interventions

Osteosclerotic Changes on Computed Tomography

Countries

Not provided

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

Oct 2024

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

Jul 1, 2010Actual

Primary Completion Date

May 30, 2023Actual

Completion Date

May 30, 2023Actual

First Submitted Date

Mar 13, 2025

First Submission Date that Met QC Criteria

Mar 13, 2025

First Posted Date

Mar 19, 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

Mar 18, 2025

Last Update Posted Date

Mar 21, 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

The study specifically investigated PC patients with bone metastasis and conducted a comprehensive analysis of the correlation between OCs and patient survival outcomes.

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

211Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Osteosclerotic Changes on Computed Tomography	Other	Osteosclerotic Changes on Computed Tomography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Radiographic progression-free survival		From enrollment to the end of treatment at 5 years

Secondary Outcomes

Measure	Description	Time Frame
overall survival		From enrollment to the end of treatment at 5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1）Histopathological confirmation of prostate adenocarcinoma
2）Radiologically verified bone metastasis, assessed through bone scintigraphy and CT imaging from the initiation of systemic therapy until disease progression.

Exclusion Criteria:

1）Lacking of complete clinical profiles.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Prostate cancer patients with bone metastasis

Sampling Method

Probability Sample

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

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms
D000230	Adenocarcinoma

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided