Robotic-arm Assisted Ga-68 PSMA PET/CT Guided Transgluteal Prostate Biopsy

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Diagnostic Test: Robotic arm assisted PSMA PET/CT guided prostate biopsy

• Registration Number: NCT05022576
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Brief Summary

Gallium-68 prostate-specific-membrane-antigen (Ga-68 PSMA) PET/CT is being used in Prostate cancer imaging. In the present study, we aimed to evaluate the efficacy and safety of robotic arm-assisted Ga-68 PSMA PET/CT-guided transgluteal prostatic biopsy.

Seventy-eight participants with a clinical suspicion of PCa were recruited from January 2019 to September 2020. All the patients underwent whole-body Ga-68 PSMA PET/CT. The patients with PSMA-avid lesion in the prostate underwent robotic arm-assisted PET-guided transgluteal biopsies. The degree of pain during the procedure, procedure-related complications and histopathology were evaluated.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-30
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30
• Status Verified: 2021-08
• Study First Submitted: 2021-08-20
• Study First Submitted QC: 2021-08-20
• Last Update Submitted: 2021-08-20
• Study First Posted: 2021-08-26
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 78

Inclusion Criteria

i. Clinically or biochemically suspected cases of Ca Prostate. ii. Patients with PSMA avid lesion in the prostate iii. Patients, who were ready to give written informed consent for biopsy iv. In good general condition (Karnofsky performance status, KPS, of more than 70).

Exclusion Criteria

i. No focal PSMA expressing lesion in the prostate ii. Patients who refused to give written informed consent iii. Abnormal coagulation profile iv. Acute prostatitis, any severe acute or chronic medical condition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PSMA PET/CT guided biopsy arm	Robotic arm assisted PSMA PET/CT guided prostate biopsy	Ga-68 PSMA PET/CT imaging is now routinely done in patients with prostate cancer with biochemical recurrence, response evaluation and even in patients with clinical suspicion of prostate cancer. In the present study, we aim to plan robotic arm-assisted Ga-68 PSMA guided transgluteal prostatic biopsies.

Primary Outcome Measures

Name	Time	Method
Safety of the procedure	Seven days	The periprocedural and post procedural adverse effects were documented
The diagnostic yield of the procedure	three months	Obtaining a biopsy specimen from the PSMA expressing site of the prostate in patients with clinical suspicion of prostate cancer to establish a pathological diagnosis.

Trial Locations

Locations (1)

Department of Nuclear Medicine, PGIMER; 🇮🇳 Chandigarh, Chandīgarh, India