Prostate CancerNCT05596851
Radio-guided Surgery With DROP-IN Beta Probe for 68Ga-PSMA, in High-risk Prostate Cancer Patients Eligible for Robotic-assisted Radical Prostatectomy.
An observational study of Prostate Cancer and Positron Emission Tomography, run by European Institute of Oncology at 1 site in Italy.
Trial summary
The goal of this observational study is to evaluate the diagnostic efficacy and the safety of the combined approach with β-probe and 68Ga-PSMA-11 PET/CT in the correct identification of lymph node metastases, in high-risk prostate cancer patients undergoing radical prostatectomy and pelvic lymph node dissection. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Positron Emission Tomography, PSMA
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 21 Mar 2022to 1 Dec 2023
- Phase
- Observational
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Biopsy proven high-risk prostate cancer patients, who performed PSMA PET/CT per clinical routine practice will be considered suitable for enrollment in case of pelvic nodal involvement detected at PSMA PET/CT. Patients affected by metastatic prostate cancer (any M) will be considered not eligible.
Who may be able to join
- Histologically proven prostate cancer
- High-risk prostate cancer (T>T2c and/or PSA>20 and/or ISUP>3)
- Patients suitable for radical prostatectomy + pelvic lymph node dissection
- 68Ga-PSMA-11 PET/CT performed within 4 weeks prior to surgery
- PSMA positive pelvic lymph nodes detected at 68Ga-PSMA-11 PET/CT
- Age >18 years old
- Willing to sign informed consent
Who cannot join
- Patient unfit for surgery
- M1 stage (any M) detected at 68Ga-PSMA-11 PET/CT or other imaging modalities performed during diagnostic wok-up evaluation
- Unable to tolerate PET scan
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IEO European Institute of Oncology
Milan, 20141
Francesco Ceci, MD PhD
Gennaro Musi, MD
About this study
Official title: PSMA Radio-Guided Lymph Node Dissection With Beta-Probe, in High-risk Prostate Cancer Patients.
The goal of this observational study is to evaluate the diagnostic efficacy and the safety of the combined approach with β-probe and 68Ga-PSMA-11 PET/CT in the correct identification of lymph node metastases, in high-risk prostate cancer patients undergoing radical prostatectomy and pelvic lymph node dissection.
Read the detailed description
Study Phase: Phase II
Primary Objective:
To evaluate the diagnostic accuracy of the combined approach with β-probe and 68Ga-PSMA-11 PET/CT in the correct identification of lymph node metastases, in high-risk prostate cancer patients undergoing radical prostatectomy and pelvic lymph node dissection. The histopathological analysis of the surgical specimens will be considered the standard of reference and diagnostic accuracy will be evaluated in terms of sensitivity and specificity.
Secondary Objectives:
- the identification of the most appropriate tumor-to-background ratio (TBR) able to correctly locate the signal emitted by PSMA-positive lymph nodes compared with the signal derived by the background rumor.
- safety and toxicity analysis regarding the intraoperative application of the β-probe.
- the comparison between the signal detected by the β-probe and 68Ga-PSMA-11 PET/CT images.
- the correlation of the signal detected by the β-probe with the PSMA expression (PSMA staining) in lymph node metastases assessed by immuno-histochemical analysis on the surgical specimens
Drug Dosage, Formulation, Administration: Intravenous administration of 1.1 MBq/Kg of 68Ga-PSMA-11.
Primary Endpoint: Primary: sensitivity and specificity in a per-region analysis.
Secondary Endpoints:
- comparison of β-probe intra-operatory measurements with ex-vivo ones.
- comparison of β-probe measurements and 68Ga-PSMA-11 semi-quantitative parameters (SUVmax and PSMA-TV).
- comparison of β-probe measurements and PSMA expression assessed by IHC (PSMA staining).
- Conditions
- Prostate Cancer, Positron Emission Tomography, PSMA
- Keywords
- PSMA, Radio-Guided Surgery, Radio Guided Surgery, Lymph Node Dissection, Prostate Cancer, PET, Positron Emission Tomography
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, specificity and positive predictive value in a per-region analysis
Measured: March 2022 - March 2023
Secondary outcomes (3)
Comparison of β-probe intra-operatory measurements with ex-vivo ones.
Measured: March 2022 - March 2023
Comparison of β-probe measurements and 68Ga-PSMA-11 semi-quantitative parameters
SUVmax and PSMA-TV will be evaluated as semi-quantitative parameters
Measured: March 2022 - March 2023
Comparison of β-probe measurements and PSMA expression assessed by immunohistochemical analysis (IHC).
IHC will be evaluated by PSMA staining on the surgical specimens.
Measured: May 2022 - December 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start21 Mar 2022
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596851
- Sponsor's protocol ID
- IEO 1703
- Status last verified
- Oct 2022
- First submitted
- 24 Oct 2022
- Last updated
- 27 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PSMA Radio-Guided Lymph Node Dissection With Beta-Probe, in High-risk Prostate Cancer Patients.
- ClinicalTrials.gov ID
- NCT05596851
- Acronym / sponsor ID
- IEO 1703
- Conditions
- Prostate Cancer, Positron Emission Tomography, PSMA
- Keywords
- PSMA, Radio-Guided Surgery, Radio Guided Surgery, Lymph Node Dissection, Prostate Cancer, PET, Positron Emission Tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 27 Oct 2022 (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.
The goal of this observational study is to evaluate the diagnostic efficacy and the safety of the combined approach with β-probe and 68Ga-PSMA-11 PET/CT in the correct identification of lymph node metastases, in high-risk prostate cancer patients undergoing radical prostatectomy and pelvic lymph node dissection.
Detailed description
Study Phase: Phase II
Primary Objective:
To evaluate the diagnostic accuracy of the combined approach with β-probe and 68Ga-PSMA-11 PET/CT in the correct identification of lymph node metastases, in high-risk prostate cancer patients undergoing radical prostatectomy and pelvic lymph node dissection. The histopathological analysis of the surgical specimens will be considered the standard of reference and diagnostic accuracy will be evaluated in terms of sensitivity and specificity.
Secondary Objectives:
- the identification of the most appropriate tumor-to-background ratio (TBR) able to correctly locate the signal emitted by PSMA-positive lymph nodes compared with the signal derived by the background rumor.
- safety and toxicity analysis regarding the intraoperative application of the β-probe.
- the comparison between the signal detected by the β-probe and 68Ga-PSMA-11 PET/CT images.
- the correlation of the signal detected by the β-probe with the PSMA expression (PSMA staining) in lymph node metastases assessed by immuno-histochemical analysis on the surgical specimens
Drug Dosage, Formulation, Administration: Intravenous administration of 1.1 MBq/Kg of 68Ga-PSMA-11.
Primary Endpoint: Primary: sensitivity and specificity in a per-region analysis.
Secondary Endpoints:
- comparison of β-probe intra-operatory measurements with ex-vivo ones.
- comparison of β-probe measurements and 68Ga-PSMA-11 semi-quantitative parameters (SUVmax and PSMA-TV).
- comparison of β-probe measurements and PSMA expression assessed by IHC (PSMA staining).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Biopsy proven high-risk prostate cancer patients, who performed PSMA PET/CT per clinical routine practice will be considered suitable for enrollment in case of pelvic nodal involvement detected at PSMA PET/CT. Patients affected by metastatic prostate cancer (any M) will be considered not eligible.
Key inclusion criteria (7 listed)
- Histologically proven prostate cancer
- High-risk prostate cancer (T>T2c and/or PSA>20 and/or ISUP>3)
- Patients suitable for radical prostatectomy + pelvic lymph node dissection
- 68Ga-PSMA-11 PET/CT performed within 4 weeks prior to surgery
- PSMA positive pelvic lymph nodes detected at 68Ga-PSMA-11 PET/CT
Key exclusion criteria (3 listed)
- Patient unfit for surgery
- M1 stage (any M) detected at 68Ga-PSMA-11 PET/CT or other imaging modalities performed during diagnostic wok-up evaluation
- Unable to tolerate PET scan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity, specificity and positive predictive value in a per-region analysis
Time frame: March 2022 - March 2023
3 secondary outcomes
Comparison of β-probe intra-operatory measurements with ex-vivo ones.
Time frame: March 2022 - March 2023
Comparison of β-probe measurements and 68Ga-PSMA-11 semi-quantitative parameters
Time frame: March 2022 - March 2023
Comparison of β-probe measurements and PSMA expression assessed by immunohistochemical analysis (IHC).
Time frame: May 2022 - December 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Related InfoLink provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Positron Emission Tomography, run by European Institute of Oncology at 1 site in Italy.
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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Oct 2022. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Ceci, MD (+39 02-57489 315, francesco.ceci@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity, specificity and positive predictive value in a per-region analysis (time frame: March 2022 - March 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2022.