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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05022576
• Other study ID #: INT/IEC/2019/001994
• Status: Completed
• Phase: N/A
• Start date: January 30, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: August 2021
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• Robotic arm assisted PSMA PET/CT guided prostate biopsy
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.

Locations

Country	Name	City	State
India	Department of Nuclear Medicine, PGIMER	Chandigarh	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Safety of the procedure	The periprocedural and post procedural adverse effects were documented	Seven days