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Imaging Guided Surgery to Improve the Detection of Lymph Node Metastases in Prostate Cancer Patients

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ClinicalTrials.gov Identifier: NCT04832958
Recruitment Status : Recruiting
First Posted : April 6, 2021
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Giorgio Gandaglia, IRCCS San Raffaele

Brief Summary:
The project aims at assessing the role of radio-guided surgery in the detection of lymph node invasion (LNI) in prostate cancer (PCa) patients undergoing radical prostatectomy (RP) by using an intraoperative gamma probe and a radioactive labelled PSMA ligand (99mTc-PSMA-I&S). We hypothesize that 99mTc-PSMA-I&S radio-guided surgery (99mTc-PSMA-RGS) might assist physicians in the identification of patients with LNI candidate for an extended pelvic lymph node dissection (ePLND). Overall, 100 men with a LNI risk >5% according to the Briganti nomogram will be submitted to 68Ga-PSMA PET/MRI followed by 99mTc-PSMA-RGS and ePLND. The aims are 1) to assess the safety and tolerability of 99mTc-PSMA-I&S; 2) to assess the accuracy of 99mTc-PSMA-RGS in the identification of LNI compared to available clinical tools and to molecular imaging (i.e., 68Ga-PSMA PET/MRI); 3) to assess whether 99mTc-PSMA-RGS would allow for the identification of positive nodes outside the standard ePLND template.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: 99m-TC-PSMA-I&S Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Role of Imaging Guided Surgery to Improve the Detection of Lymph Node Metastases in Prostate Cancer Patients Treated With Radical Prostatectomy and Extended Pelvic Lymph Node Dissection
Estimated Study Start Date : April 15, 2021
Estimated Primary Completion Date : November 15, 2023
Estimated Study Completion Date : November 15, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Radioguided surgery
  • 68Ga-PSMA PET/MRI acquisition
  • 99mTc-PSMA-I&S intravenous injection the day before surgery
  • 99mTc-PSMA-I&S SPECT/CT imaging
  • 99mTc-PSMA-RGS to detect an increased count rate at the level of the nodal stations
  • Robot-assisted ePLND followed by RP
  • 99mTc-PSMA-RGS to detect an increased count rate in the prostatic fossa after removal of the primary tumor
  • Histopathological examination
  • Monitoring of adverse events and perioperative outcomes after surgery
Drug: 99m-TC-PSMA-I&S
  • 99mTc-PSMA-I&S intravenous injection the day before surgery
  • 99mTc-PSMA-I&S SPECT/CT imaging
  • 99mTc-PSMA-RGS to detect an increased count rate at the level of the nodal stations




Primary Outcome Measures :
  1. Rate of lymph node invasion [ Time Frame: 12 weeks ]
    Rate of LNI observed at final pathology after 99mTc-PSMA-RGS (histopathological evaluation of the lymph nodes)


Secondary Outcome Measures :
  1. Side effects [ Time Frame: day 0 ]
    Side effects associated with the administration of 99mTC-PSMA-I&S (day 0)

  2. Postoperative complications [ Time Frame: day 28 and day 84 ]
    Rate of intraoperative complications associated with 99mTc-PSMA-RGS assessed at visit 2

  3. Nodal invasion outside the template [ Time Frame: 12 weeks ]
    Rate of LNI observed at final pathology in nodes outside the extended nodal dissection template detected only by 99mTc-PSMA-RGS



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male patients
  • Age between 18 and 80 years
  • Biopsy proven PCa with a LNI risk >5% according to the Briganti nomogram
  • Planned to receive a RARP with an ePLND
  • Able to understand and willing to sign a written informed consent document

Exclusion Criteria:

  • Receipt of neoadjuvant therapies
  • Inability to complete the imaging examinations according to the prospective protocol
  • Evidence of metastatic disease at conventional imaging before surgery
  • Evidence of clinical lymphadenopathies at conventional imaging before surgery
  • Life expectancy of less than 12 months
  • Previous chemotherapy
  • Previous brachytherapy or external beam radiotherapy
  • Unstable cardiovascular disease
  • Congestive Heart Failure (CHF)
  • Clinically significant hepatobiliary or renal disease
  • History of significant CNS injuries within 6 months
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
  • Medical history of allergic disease or reactions likely to be exacerbated by the IMPs used in this study or by any of the components of the radiotracers (99mTc-PSMA-I&S and 68Ga-PSMA)
  • Patients who received an experimental drug in the context of clinical trials within 30 days from the administration of the radiotracers in the current investigation or within 5 half-lives of the experimental drug itself

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04832958


Locations
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Italy
Ospedale San Raffaele Recruiting
Milan, MI, Italy, 20132
Contact: Giorgio Gandaglia, MD    00390226434066    gandaglia.giorgio@hsr.it   
Contact: Elio Mazzone       mazzone.elio@hsr.it   
Sub-Investigator: Francesco Montorsi, Prof         
Sub-Investigator: Alberto Briganti, Prof         
Principal Investigator: Nicola Fossati, MD         
Sub-Investigator: Elio Mazzone, MD         
Sub-Investigator: Vito Cucchiara, MD         
Sponsors and Collaborators
IRCCS San Raffaele
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Responsible Party: Giorgio Gandaglia, MD, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT04832958    
Other Study ID Numbers: PSMA RGS
First Posted: April 6, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Giorgio Gandaglia, IRCCS San Raffaele:
radical prostatectomy
lymph node dissection
lymph node invasion
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases