68Ga-PSMA PET in the Prostate Cancer

NCT ID: NCT04967001

Last Updated: 2024-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Prostatic Neoplasms Metastases PSMA-PET

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PSMAPET-MRI

Group Type EXPERIMENTAL

PSMA PET

Intervention Type DIAGNOSTIC_TEST

68Ga-PSMA PET

MRI-PSMAPET

Group Type EXPERIMENTAL

PSMA PET

Intervention Type DIAGNOSTIC_TEST

68Ga-PSMA PET

Interventions

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PSMA PET

68Ga-PSMA PET

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Qin Weijun

Professor and Director, Department of Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Xijing Hospital

Xi'an, Shannxi, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Yanyan Jia

Role: primary

+86 029 8477 1794

Other Identifiers

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KY20212032-F-1

Identifier Type: -

Identifier Source: org_study_id

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