NCT06915714

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2025

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 8, 2025

Completed
Last Updated

April 8, 2025

Status Verified

March 1, 2025

Enrollment Period

9 months

First QC Date

March 22, 2025

Last Update Submit

April 4, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

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

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First affiliated hospital, Sun Yat-sen univeristy

Guangzhou, Guangdong, 510080, China

Location

Study Officials

  • Fangzheng Xiang

    First affiliated hospital, Sun Yat-sen univeristy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Phd, Md

Study Record Dates

First Submitted

March 22, 2025

First Posted

April 8, 2025

Study Start

June 2, 2024

Primary Completion

February 20, 2025

Study Completion

February 28, 2025

Last Updated

April 8, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations