Clinical trial · Interventional
Brief Title: INTROSPECT: Intraoperative PSMA PET/CT Imaging During Radical Prostatectomy
INTROSPECT: INTRa-Operative PSMA-PET/CT for Radical Prostatectomy - A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Margin Assessment | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| PSMA PET/CT | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| study-specific administration of 68Ga-PSMA-11 followed by ex vivo PET/CT imaging of the prostatectomy specimen | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Participants with prostate cancer undergoing robot-assisted radical prostatectomy.
- description
- 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
- interventionNames
- Radiation: study-specific administration of 68Ga-PSMA-11 followed by ex vivo PET/CT imaging of the prostatectomy specimen
Primary outcomes (1)
- measure
- Concordance between ex vivo PSMA PET/CT imaging and histopathology
- timeFrame
- Day 0 (surgery) - From intravenous injection (Gallium PSMA), PET-PSMA, prostatectomy, through histopathological results (Day 10 post-surgery).
- description
- 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).
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDMoraitis 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
- BACKGROUNDOderda 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
- BACKGROUNDDarr 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