Radio-guided Surgery With DROP-IN Beta Probe for 68Ga-PSMA, in High-risk Prostate Cancer Patients Eligible for Robotic-assisted Radical Prostatectomy.

October 24, 2022 updated by: European Institute of Oncology

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milan, Italy, 20141
        • Recruiting
        • IEO European Institute of Oncology
        • Contact:
          • Francesco Ceci, MD PhD
        • Contact:
          • Gennaro Musi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity, specificity and positive predictive value in a per-region analysis
Time Frame: March 2022 - March 2023
March 2022 - March 2023

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of β-probe intra-operatory measurements with ex-vivo ones.
Time Frame: March 2022 - March 2023
March 2022 - March 2023
Comparison of β-probe measurements and 68Ga-PSMA-11 semi-quantitative parameters
Time Frame: March 2022 - March 2023
SUVmax and PSMA-TV will be evaluated as semi-quantitative parameters
March 2022 - March 2023
Comparison of β-probe measurements and PSMA expression assessed by immunohistochemical analysis (IHC).
Time Frame: May 2022 - December 2023
IHC will be evaluated by PSMA staining on the surgical specimens.
May 2022 - December 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Institute of Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2022

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

October 24, 2022

First Submitted That Met QC Criteria

October 24, 2022

First Posted (Actual)

October 27, 2022

Study Record Updates

Last Update Posted (Actual)

October 27, 2022

Last Update Submitted That Met QC Criteria

October 24, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IEO 1703

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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