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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Robotic arm assisted PSMA PET/CT guided prostate biopsy
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Positron Emission Tomography Computed Tomography, Glu-NH-CO-NH-Lys-(Ahx)-((68)Ga(HBED-CC)), Biopsy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Nuclear Medicine, PGIMER

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PSMA PET/CT guided biopsy arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
Safety of the procedure
The periprocedural and post procedural adverse effects were documented

Secondary Outcome Measures

Full Information

First Posted
August 20, 2021
Last Updated
August 20, 2021
Sponsor
Postgraduate Institute of Medical Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT05022576
Brief Title
Robotic-arm Assisted Ga-68 PSMA PET/CT Guided Transgluteal Prostate Biopsy
Official Title
Trans Gluteal Automated Robotic Arm Assisted Ga-68 Prostate-specific Membrane Antigen Position Emission Tomography/ Computed Tomography Guided Percutaneous Prostate Biopsies.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 30, 2019 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Positron Emission Tomography Computed Tomography, Glu-NH-CO-NH-Lys-(Ahx)-((68)Ga(HBED-CC)), Biopsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PSMA PET/CT guided biopsy arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Robotic arm assisted PSMA PET/CT guided prostate biopsy
Intervention Description
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.
Primary Outcome Measure Information:
Title
The diagnostic yield of the procedure
Description
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.
Time Frame
three months
Title
Safety of the procedure
Description
The periprocedural and post procedural adverse effects were documented
Time Frame
Seven days

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Evaluation of patients with clinically suspected prostate cancer which is applicable to male patients only
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Nuclear Medicine, PGIMER
City
Chandigarh
State/Province
Chandīgarh
ZIP/Postal Code
160012
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data can be obtained directly from the principal investigator on reasonable request.
Citations:
PubMed Identifier
35191735
Citation
Kumar R, Singh SK, Mittal BR, Vadi SK, Kakkar N, Singh H, Krishnaraju VS, Kumar S, Bhattacharya A. Safety and Diagnostic Yield of 68Ga Prostate-specific Membrane Antigen PET/CT-guided Robotic-assisted Transgluteal Prostatic Biopsy. Radiology. 2022 May;303(2):392-398. doi: 10.1148/radiol.204066. Epub 2022 Feb 22.
Results Reference
derived

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

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