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

Study Overview
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Brief Summary
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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.

Official Title
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Trans Gluteal Automated Robotic Arm Assisted Ga-68 Prostate-specific Membrane Antigen Position Emission Tomography/ Computed Tomography Guided Percutaneous Prostate Biopsies.

Conditions
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Prostate Cancer

Intervention / Treatment
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* Diagnostic Test: Robotic arm assisted PSMA PET/CT guided prostate biopsy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PSMA PET/CT guided biopsy arm<br>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. | Diagnostic Test: Robotic arm assisted PSMA PET/CT guided prostate biopsy<br>* The patients were positioned prone on PET/CT table. The regional PET/CT image of the lower pelvic region were acquired for the procedure. The images were transferred to the ROBIO™ EX workstation. The ARA workstation determined the needle trajectory, depth of the lesion and angulations. The planned trajectory was appraised for its relationship with the vital organs. Strict surgical aseptic approach was followed for the procedure under local anesthesia. An 18G x 20cm coaxial system was manually introduced through the bush and pushed with the help of robotic arm through the gluteal skin entry site to the predetermined depth in the prostate. The real-time placement of the needle was confirmed with low dose CT and the biopsy specimens were retrieved. After the procedure, patient vitals and any difficulty in micturition were observed for two hours in the recovery area. The specimens were sent for histopathological examination.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The diagnostic yield of the procedure | 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. | three months | 
| Safety of the procedure | The periprocedural and post procedural adverse effects were documented | Seven days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Positron Emission Tomography Computed Tomography, Glu-NH-CO-NH-Lys-(Ahx)-((68)Ga(HBED-CC)), Biopsy