Prostate CancerNCT05022576
Robotic-arm Assisted Ga-68 PSMA PET/CT Guided Transgluteal Prostate Biopsy
A study testing Robotic arm assisted PSMA PET/CT guided prostate biopsy in people with Prostate Cancer, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Robotic arm assisted PSMA PET/CT guided prostate biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteIndia
- Study dates
- 30 Jan 2019to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Department of Nuclear Medicine, PGIMER
Chandigarh, Chandigarh, 160012
About this study
Official title: Trans Gluteal Automated Robotic Arm Assisted Ga-68 Prostate-specific Membrane Antigen Position Emission Tomography/ Computed Tomography Guided Percutaneous Prostate Biopsies.
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.
- Conditions
- Prostate Cancer
- Being tested
- Robotic arm assisted PSMA PET/CT guided prostate biopsy
- Keywords
- Positron Emission Tomography Computed Tomography, Glu-NH-CO-NH-Lys-(Ahx)-((68)Ga(HBED-CC)), Biopsy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic arm assisted PSMA PET/CT guided prostate biopsyDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| PSMA PET/CT guided biopsy arm | Experimental | 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. Receives: Diagnostic Test: Robotic arm assisted PSMA PET/CT guided prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: three months
Safety of the procedure
The periprocedural and post procedural adverse effects were documented
Measured: Seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start30 Jan 2019
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajender Kumar, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022576
- Sponsor's protocol ID
- INT/IEC/2019/001994
- Status last verified
- Aug 2021
- First submitted
- 20 Aug 2021
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data can be obtained directly from the principal investigator on reasonable request.
Publications
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.
PubMed 35191735
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans Gluteal Automated Robotic Arm Assisted Ga-68 Prostate-specific Membrane Antigen Position Emission Tomography/ Computed Tomography Guided Percutaneous Prostate Biopsies.
- ClinicalTrials.gov ID
- NCT05022576
- Acronym / sponsor ID
- INT/IEC/2019/001994
- Conditions
- Prostate Cancer
- Keywords
- Positron Emission Tomography Computed Tomography, Glu-NH-CO-NH-Lys-(Ahx)-((68)Ga(HBED-CC)), Biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 26 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PSMA PET/CT guided biopsy arm | Experimental | Diagnostic Test: Robotic arm assisted PSMA PET/CT guided prostate biopsyGa-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. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic arm assisted PSMA PET/CT guided prostate biopsyThe 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. | Diagnostic test | PSMA PET/CT guided biopsy arm |
Primary outcome
The diagnostic yield of the procedure
Time frame: 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.
Safety of the procedure
Time frame: Seven days
The periprocedural and post procedural adverse effects were documented
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Derived from this study: PubMed 35191735Kumar 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.
- Individual participant dataSharing planned: Yes. Individual participant data can be obtained directly from the principal investigator on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic arm assisted PSMA PET/CT guided prostate biopsy in people with Prostate Cancer, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnostic yield of the procedure (time frame: three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05022576, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.