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

NCT04832958 | Completed Phase 2 DMC

• 1 other identifier: PSMA RGS
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

radical prostatectomy; lymph node dissection; lymph node invasion

Outcome Measures

Primary Outcomes (1)

• Rate of lymph node invasion

  Rate of LNI observed at final pathology after 99mTc-PSMA-RGS (histopathological evaluation of the lymph nodes)

  12 weeks

Secondary Outcomes (3)

• Side effects

  day 0

• Postoperative complications

  day 28 and day 84

• Nodal invasion outside the template

  12 weeks

Study Arms (1)

Radioguided surgery

EXPERIMENTAL

* 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

Interventions

99m-TC-PSMA-I&S DRUG

* 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

Radioguided surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

Ospedale San Raffaele

Milan, MI, 20132, Italy

Location

Related Publications (1)

• Gandaglia G, Mazzone E, Stabile A, Pellegrino A, Cucchiara V, Barletta F, Scuderi S, Robesti D, Leni R, Samanes Gajate AM, Picchio M, Gianolli L, Brembilla G, De Cobelli F, van Oosterom MN, van Leeuwen FWB, Montorsi F, Briganti A. Prostate-specific membrane antigen Radioguided Surgery to Detect Nodal Metastases in Primary Prostate Cancer Patients Undergoing Robot-assisted Radical Prostatectomy and Extended Pelvic Lymph Node Dissection: Results of a Planned Interim Analysis of a Prospective Phase 2 Study. Eur Urol. 2022 Oct;82(4):411-418. doi: 10.1016/j.eururo.2022.06.002. Epub 2022 Jul 22.

  PMID: 35879127 DERIVED

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 Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 3, 2021
• First Posted: April 6, 2021
• Study Start: May 15, 2021
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: March 14, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)