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

NCT07829068 | Active Not Recruiting

• 2 other identifiers: 2025-004582025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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. All participants will receive an injection of a radiotracer (\[68Ga\]Ga-PSMA-11) at the beginning of surgery. Images will then be compared with 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.

Conditions

Prostate Cancer; PSMA PET/CT; Margin Assessment

Keywords

Prostatectomy; Positron Emission Tomography Computed Tomography; Intraoperative care

Outcome Measures

Primary Outcomes (1)

• Concordance between ex vivo PSMA PET/CT imaging and histopathology

  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 Outcomes (4)

• Radiation exposure of operating room staff

  Day 0 - prostatectomy

• Radioactivity of the prostate specimen

  Day 0 - prostatectomy

• Concordance between in vivo and ex vivo imaging

  From preoperative imaging (Day -180) to intraoperative ex vivo PSMA PET/CT (Day 1 post-surgery)

• Image interpretability and tumor segmentation

  From intraoperative ex vivo PSMA PET/CT (Day 0 surgery) to image interpretation (Day 0)

Study Arms (1)

Participants with prostate cancer undergoing robot-assisted radical prostatectomy.

EXPERIMENTAL

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

Interventions

study-specific administration of 68Ga-PSMA-11 followed by ex vivo PET/CT imaging of the prostatectomy specimen RADIATION

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.

Participants with prostate cancer undergoing robot-assisted radical prostatectomy.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of intermediate- or high-risk prostate cancer.
• Preoperative PSMA PET staging with positive uptake in the primary tumor.
• Capacity to provide informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Hôpitaux Universitaires de Genève - Dept de Chirurgie - Service d'Urologie

Geneva, Canton of Geneva, 1205, Switzerland

Location

Related Publications (3)

• Moraitis A, Kahl T, Kandziora J, Jentzen W, Kersting D, Pullen L, Reis H, Kollermann J, Kesch C, Krafft U, Hadaschik BA, Zaidi H, Herrmann K, Barbato F, Fendler WP, Darr C, Fragoso Costa P. Evaluation of Surgical Margins with Intraoperative PSMA PET/CT and Their Prognostic Value in Radical Prostatectomy. J Nucl Med. 2025 Mar 3;66(3):352-358. doi: 10.2967/jnumed.124.268719.

  PMID: 39915125 BACKGROUND

• Oderda M, Grimaldi S, Rovera G, Delsedime L, D'Agate D, Lavagno F, Marquis A, Marra G, Molinaro L, Deandreis D, Gontero P. Robot-assisted PSMA-radioguided Surgery to Assess Surgical Margins and Nodal Metastases in Prostate Cancer Patients: Report on Three Cases Using an Intraoperative PET-CT Specimen Imager. Urology. 2023 Dec;182:e257-e261. doi: 10.1016/j.urology.2023.08.013. Epub 2023 Sep 3.

  PMID: 37669707 BACKGROUND

• Darr C, Costa PF, Kahl T, Moraitis A, Engel J, Al-Nader M, Reis H, Kollermann J, Kesch C, Krafft U, Maurer T, Kohler D, Klutmann S, Falkenbach F, Kleesiek J, Fendler WP, Hadaschik BA, Herrmann K. Intraoperative Molecular Positron Emission Tomography Imaging for Intraoperative Assessment of Radical Prostatectomy Specimens. Eur Urol Open Sci. 2023 Jun 15;54:28-32. doi: 10.1016/j.euros.2023.05.017. eCollection 2023 Aug.

  PMID: 37361199 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Massimo Valerio, Prof Dr med

  Geneva University Hospitals (HUG)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr med

Model Details: Prospective, single-center, nonrandomized pilot study, IDEAL Stage 2a

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: May 30, 2025
• Primary Completion: February 12, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: 6 months (start date) - 36 months (end date) after publication
• 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

Locations

CH (1)