NCT06604377

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
203

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

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

November 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

8 months

First QC Date

September 11, 2024

Last Update Submit

September 17, 2024

Conditions

Prostate Cancer

Keywords

PET/MRProstate cancerBiochemical recurrenceMulticenter

Outcome Measures

Primary Outcomes (1)

  • 18F-PSMA-1007 PET/MR image parameters

    Before surgery

Secondary Outcomes (1)

  • Biochemical recurrence-free survival time

    3 years

Study Arms (1)

Shanghai East Hospital, Tongji University School of Medicine

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

Other: Observe

Interventions

ObserveOTHER

Ruijin

Shanghai East Hospital, Tongji University School of Medicine

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Age ≥ 18 years
  • Histologically confirmed prostate cancer without other types of malignancy -

You may not qualify if:

  • Surgery or endocrine therapy is performed prior to the examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine

Shanghai, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Otolaryngology

Study Record Dates

First Submitted

September 11, 2024

First Posted

September 19, 2024

Study Start

November 1, 2023

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)