68Ga-PSMA PET in the Prostate Cancer | NCT04967001

Studies
68Ga-PSMA PET in the Prostate Cancer

NCT04967001

Sponsor

Xijing Hospital

Status

Unknown status

Last Update Posted

Jan 25, 2024Actual

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Prostatic Neoplasms
Metastases
PSMA-PET

Interventions

PSMA PET

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

Jan 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2021Actual

Primary Completion Date

Jun 1, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Jul 11, 2021

First Submission Date that Met QC Criteria

Jul 11, 2021

First Posted Date

Jul 19, 2021Actual

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

Jan 23, 2024

Last Update Posted Date

Jan 25, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Efficacy of 68Ga PSMA PET / CT in the diagnosis of lymph node metastasis in patients with prostate cancer: a single center prospective randomized controlled trial.

To identify and compare the diagnostic efficacy of 68Ga-PSMA PET/CT and mpMRI for lymph nodes in patients with newly diagnosed prostate cancer.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PSMAPET-MRI	Experimental		Diagnostic Test: PSMA PET
MRI-PSMAPET	Experimental		Diagnostic Test: PSMA PET

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PSMA PET	Diagnostic Test	68Ga-PSMA PET	MRI-PSMAPET PSMAPET-MRI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic accuracy of PSMA PET and combined PSMA PET/MRI or PSMA PET/CT	To compare the diagnostic accuracy of PSMA PET and combined PSMA PET/MRI or PET/CT to that of the current standard multiparametric MRI, using histopathology as the gold standard.	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

High risk localized/locally advanced prostate cancer patients who are candidates for radical prostatectomy plus bilateral extended PLND
ISUP Gleason grade group ≥ 4

Exclusion Criteria:

Prior history of any other cancer in the last 5 years excluding basal cell carcinoma Proven metastases in bones or other distant metastases
General contra-indications for MRI (pacemaker, aneurysm clips, any form of metal in the body, severe claustrophobia)
Serious concomitant systemic disorders that in the opinion of the investigator would compromise the patient's ability to complete the study or interfere with the evaluation of the efficacy and safety of the study objectives
Metal implants in the pelvic region which will deteriorate PET/MR/CT image quality.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xijing Hospital	Recruiting	Xi'an	Shannxi	710032	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

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms
D009362	Neoplasm Metastasis

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