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68Ga-PSMA PET in the Prostate Cancer

A

Air Force Military Medical University of People's Liberation Army

Status

Enrolling

Conditions

PSMA-PET
Metastases
Prostatic Neoplasms

Treatments

Diagnostic Test: PSMA PET

Study type

Interventional

Funder types

Other

Identifiers

NCT04967001
KY20212032-F-1

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

Male

Ages

40 to 90 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

300 participants in 2 patient groups

PSMAPET-MRI
Experimental group
Treatment:
Diagnostic Test: PSMA PET
MRI-PSMAPET
Experimental group
Treatment:
Diagnostic Test: PSMA PET

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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