Brief Title: INTROSPECT: Intraoperative PSMA PET/CT Imaging During Radical Prostatectomy (INTROSPECT)

September 14, 2026 updated by: Massimo Valerio, University Hospital, Geneva

INTROSPECT: INTRa-Operative PSMA-PET/CT for Radical Prostatectomy - A Pilot Study

During prostate cancer surgery, the surgeon aims to remove the tumor completely while preserving the surrounding tissue responsible for urinary continence and sexual potency. However, during surgery, it can be difficult to distinguish cancerous tissue from surrounding healthy tissue and therefore to determine the exact extent of the tumor. As a result, cancer cells may sometimes remain at the edge of the removed prostate, resulting in what is known as a positive surgical margin. Currently, positive surgical margins are identified by histopathology of the prostate specimen, with the results becoming available several days after surgery.

The long-term goal of intraoperative imaging is to provide surgeons with information about tumor extent and surgical margins while the operation is still ongoing. This information could allow surgeons to remove additional cancerous tissue during the same procedure while helping preserve surrounding healthy structures. This pilot study INTROSPECT is an initial step toward this goal.

INTROSPECT is a prospective pilot study at Geneva University Hospitals evaluating a PET/CT Scanner (AURA-10, Xeos Medical, Belgium) to analyze the prostate specimen directly in the operating room (results in 12 minutes). We plan to include 30 participants. They will all receive an injection of a radiotracer (gallium-68 PSMA-11) at the beginning of surgery. Images will be then compared to the microscopic evaluation to find out how accurately they show the location and extent of the cancer.

In this pilot study, the PET/CT findings will not be used to modify the surgical procedure or to remove additional tissue. The study is designed to determine whether the technique is sufficiently accurate and feasible to support future studies evaluating its use for real-time surgical decision-making.

The study will also assess radiation exposure to operating room personnel and explore methods for interpreting and segmenting the PET images.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Intraoperative Margin Assessment (IMA) in Robotic-Assisted Radical Prostatectomy (RARP) has the potential to reduce the 30% Positive Surgical Margin (PSM) rate.

Nevertheless, the leading technique, NeuroSAFE, is based on the Intraoperative Frozen section (IFS) of the lateral halves of the prostate, which, despite demonstrated oncological benefits comes with several drawbacks. First, implementation is largely restricted to specialized center as it requires dedicated pathology equipment (cryostat) and a uropathologist team trained to the technique. Secondly, apical and basal regions are not assessed therefore missing potential margins, frequently located in the apex. Finally, results are obtained in 45 minutes, potentially increasing operating time.

In this context intraoperative PSMA-PET margin assessment has been recently introduced using the CE-marked AURA-10 Device (Xeos Medical, Belgium) which can provide results within 12 minutes. Several previous studies confirmed the feasability of the procedure in the oncological settings. Regarding prostate cancer, only patients presenting high-risk prostate cancer were included, with a detection of 67% to 100% of PSM. Unfortunately, available evidence remains preliminary with several aspects requiring further investigation (population which can benefit of the technology, validation against histopathology, image interpretation [inter-reader agreement, segmentation methods] …). Also, clinical implementation requires a characterization of staff radiation exposure and residual specimen activity.

To address these questions, we designed INTROSPECT, a prospective IDEAL Stage 2a, single center, pilot study at Geneva University Hospitals. We aim to enroll 30 patients with intermediate or high-risk prostate cancer (PCa) scheduled for RARP. Eligibility requires uptake of the index lesion on preoperative PSMA PET imaging and an indication for radical prostatectomy after multidisciplinary Tumor Board presentation. Participants will undergo RARP with lymph node dissection when clinically indicated. The research procedures include intraoperative intravenous administration of gallium-68 PSMA-11 at 1.0 MBq/kg. The freshly resected prostate is placed in a dedicated holder and scanned in the operating room. The primary objective is to evaluate the concordance between ex-vivo PSMA and final histopathology. Secondary objectives include image interpretability evaluation and concordance with preoperative imaging modalities. We will also evaluate occupational exposure and residual specimen activity.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Switzerland
    • Canton of Geneva
      • Geneva, Canton of Geneva, Switzerland, 1205
        • Hôpitaux Universitaires de Genève - Dept de Chirurgie - Service d'Urologie

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of intermediate- or high-risk prostate cancer.
  • Preoperative PSMA PET staging with positive uptake in the primary tumor.
  • Multidisciplinary approval by the urology tumor board for radical prostatectomy and study inclusion.
  • Capacity to provide informed consent

Exclusion Criteria:

  • Refusal to participate or withdrawal from the study.
  • Inability to follow study procedures, for example because of language difficulties, psychological disorders or dementia.
  • Participation in another clinical trial requiring ex vivo prostate tissue for research.
  • Prior treatment that may alter PSMA uptake, such as androgen deprivation therapy or radiotherapy.
  • Variant prostate cancer histology, such as neuroendocrine cancer.
  • Insufficient-quality or unavailable PSMA PET images, including corrupted data, or an incomplete histopathology report.

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants with prostate cancer undergoing robot-assisted radical prostatectomy.
Adult men with intermediate or high-risk prostate cancer with a PSMA -avid tumor (preoperative PET imaging) and a multidisciplinary indication for radical prostatectomy. Reference Standard is the histopathological analysis. No intraoperative re-resection is performed based on intraoperative results
Radiation: study-specific administration of 68Ga-PSMA-11 followed by ex vivo PET/CT imaging of the prostatectomy specimen
Single intravenous injection of 1.0 MBq/kg Gallium-PSMA, administered during surgery (docking phase). PET/CT imaging of the freshly resected prostate specimen in the operating room using the AURA 10 device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance between ex vivo PSMA PET/CT imaging and histopathology
Time Frame: Day 0 (surgery) - From intravenous injection (Gallium PSMA), PET-PSMA, prostatectomy, through histopathological results (Day 10 post-surgery).
Concordance between intraoperative ex vivo PSMA PET/CT imaging and the final histopathological analysis/results of the prostate specimen including positive surgical margin assessment and lesion by lesion analysis (tumor extent).
Day 0 (surgery) - From intravenous injection (Gallium PSMA), PET-PSMA, prostatectomy, through histopathological results (Day 10 post-surgery).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiation exposure of operating room staff
Time Frame: Day 0 - prostatectomy
Operating Room Staff (senior attending surgeon, fellow, scrub nurse, bedside assistant, circulating nurse, anaesthesiologist, installation technician) will wear Electronic Personal Dosimeter (DMC 3000™, Mirion Technologies, USA) to assess the Whole-Body Dose, Hp(10). The bedside assistant will also wear an extremity dosimeter (ED3, Rotunda Scientific Technologies LLC, USA) to measure Hp(0.07).
Day 0 - prostatectomy
Radioactivity of the prostate specimen
Time Frame: Day 0 - protatectomy
Residual specimen activity will be measured with a High-Purity Germanium Detector.
Day 0 - protatectomy
Concordance between in vivo and ex vivo imaging
Time Frame: From preoperative imaging (Day -180) to intraoperative ex vivo PSMA PET/CT (Day 1 post-surgery)
Concordance in tumor localization and extent between preoperative imaging and intraoperative ex vivo PSMA PET/CT.
From preoperative imaging (Day -180) to intraoperative ex vivo PSMA PET/CT (Day 1 post-surgery)
Image interpretability and tumor segmentation
Time Frame: From intraoperative ex vivo PSMA PET/CT (Day 0 surgery ) to image interpretation (Day 0)
Guidance for image interpretation, different tumour segmentation methods and inter-reader variability.
From intraoperative ex vivo PSMA PET/CT (Day 0 surgery ) to image interpretation (Day 0)

Collaborators and Investigators

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

Sponsor

University Hospital, Geneva

Investigators

  • Principal Investigator: Massimo Valerio, Prof Dr med, Geneva University Hospitals (HUG)

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.

General Publications

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)

May 30, 2025

Primary Completion (Actual)

February 12, 2026

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

September 14, 2026

First Submitted That Met QC Criteria

September 14, 2026

First Posted (Actual)

September 18, 2026

Study Record Updates

Last Update Posted (Actual)

September 18, 2026

Last Update Submitted That Met QC Criteria

September 14, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-00458
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual imaging data and pathological data will be available. Data will be provided only for analyses aiming at developping the technique. Study protocol, Statistical Analysis Plan and Statistical Code will be available for anyone requesting it. Proposals should be directed to olivier.windisch@hug.ch

IPD Sharing Time Frame

6 months (start date) - 36 months (end date) after publication

IPD Sharing Access Criteria

Data will be shared only with researchers who also use the technology on a regular-basis during radical prostatectomy, provide a methodologically sound proposal, previously approved by an independent review board, in the context of multicentric collaboration only. Data will be provided only for analyses aiming at developping the technique.

Proposals should be directed to olivier.windisch@hug.ch

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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