Radio Guided Lymph Node Dissection in Oligometastatic Prostate Cancer Patients

NCT04300673 | Unknown Phase 1

• 2 other identifiers: 2019-58052019-003284-21
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The study is a prospective, single arm phase I/II study. The primary aim of this study is to evaluate the feasibility of 111In-PSMA I\&T radio guided surgery in patients diagnosed with prostate cancer who are highly suspected of having one or more pelvic lymph node metastases based on pre-operative imaging. Patients with prostate cancer who have a high risk of lymph node metastases based on PSMA PET/CT and scheduled for robot-assisted PLND (with or without prostatectomy) will be recruited. Eligible patients will receive an additional ferumoxtran-10 enhanced MRI to complement pre-operative imaging. Twenty-four hours before surgery, patients will receive the radiolabelled PSMA tracer. Pelvic Lymph node dissections are carried out according to standard of care procedures. During surgery, the surgeon will be provided with a gamma-probe to detect PSMA expressing lymph nodes in vivo. Dissected samples will be systematically assessed on tracer accumulation using the gamma-probe ex vivo. After surgery, the samples will be scanned in the small animal SPECT/CT and 7T-MRI. After scanning, samples will be presented to pathologists for pathological analysis according to standard of care including staining for PSMA expression. At 3 months after surgery, patients will undergo a PSMA-PET/CT. Up until one year after surgery patients will be followed according to standard of care-guidelines by 3-monthly serum-PSA measurements.

Conditions

Prostate Cancer; Lymph Node Metastases

Keywords

pelvic lymph node dissection (PLND); PSMA I&T; radio guided surgery (RGS)

Outcome Measures

Primary Outcomes (1)

• Feasibility of 111In-PSMA-I&T radio guided surgery

  The primary aim of this study is to evaluate the feasibility of 111In-PSMA-I\&T radio guided surgery in patients diagnosed with prostate cancer who are highly suspected of having one or more pelvic lymph node metastasis/metastases based on pre-operative imaging. Feasibility will be defined as the ability to intra-operatively detect the lymph nodes (using a gamma probe) which were pre-operatively identified on PSMA-PET/CT

  1 year

Secondary Outcomes (6)

• The accuracy of 111In-PSMA-I&T radio guided surgery

  1 year

• The safety of 111In-PSMA-I&T

  1 year

• Dosimetry of 111In-PSMA-I&T

  1 year

• Correlation between tracer accumulation and lymph node size, PSMA-staining and SUV on PSMA-PET/CT

  1 year

• Correlation between post-operative nano-MRI and SPECT

  1 year

Study Arms (1)

All patients

EXPERIMENTAL

Intervention: radio guided surgery

Procedure: Radio guided surgery (RGS) using Indium-labelled PSMA

Interventions

Radio guided surgery (RGS) using Indium-labelled PSMA PROCEDURE

Approximately 24hours prior to surgery (PLND) patients receive a radiolabelled PSMA-tracer. During surgery, urologists will use a gamma-probe to detect PSMA-postitive tumour depostitions in pelvic lymph nodes.

All patients

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: Study concerns prostate cancer patients.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven cancer of the prostate, based on prostate biopsy-core analysis.
• At least one 18F/68Ga-PSMA-PET/CT suspected positive metastasis in lymph nodes, located in the pelvic region.
• Patient is scheduled and fit for robot assisted surgery (PLND or radical prostatectomy +PLND).
• Patient is suitable for PLND (and radical prostatectomy) conform institutional guidelines and is not yet treated pre-operatively .
• Age≥50 years.
• Ability to give voluntary written informed consent to participate in this study.

You may not qualify if:

• No detectable lesion on the 18F/68Ga-PSMA-PET/CT with an uptake level above liver uptake level (reference).
• Patients who are not scheduled for robot-assisted PLND.
• Prior pelvic surgery(1)
• Unequivocal evidence of metastases outside the pelvic region.
• Presence of any medical condition that in the opinion of the investigator/treating physician will affect patients' clinical status by participating in this trial.
• Prior prostate cancer treatment(2).
• Contraindication for MRI-scanning, i.e. claustrophobia, intracranial metal clips, metallic bodies in the eye, implanted electric and electronic devices not eligible for MRI (pacemakers, insulin pumps, cochlear implants, neurostimulators).
• Inability to lie still for at least 60 minutes or comply with imaging.
• Contraindication for iron infusion or hypersensitivity/allergy to the active substance or any of the excipients.
• The patient is already enrolled in one or more concurrent studies, which could confound the results of this study, according to the investigators.
• Pelvic surgery is defined as "any surgery associated with pelvic lymphadenopathy'.
• Prior prostate cancer treatment is defined as prostate and/or pelvic radiotherapy, hormonal treatments such as androgen deprivation therapy, prostate brachytherapy, prostate cryotherapy, high intensity focused ultrasound (HIFU) and/or prostate electroporation.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (2)

Radboudumc

Nijmegen, Gelderland, 6525, Netherlands

Location

Canisius Wilhelimina Ziekenhuis

Nijmegen, Netherlands

Location

Related Publications (1)

• Schilham MGM, Somford DM, Kusters-Vandevelde HVN, Hermsen R, van Basten JPA, Hoekstra RJ, Scheenen TWJ, Gotthardt M, Sedelaar JPM, Rijpkema M. Prostate-Specific Membrane Antigen-Targeted Radioguided Pelvic Lymph Node Dissection in Newly Diagnosed Prostate Cancer Patients with a Suspicion of Locoregional Lymph Node Metastases: The DETECT Trial. J Nucl Med. 2024 Mar 1;65(3):423-429. doi: 10.2967/jnumed.123.266495.

  PMID: 38176721 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Lymphatic Metastasis

Interventions

PITX2 protein, human

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michiel Sedelaar, MD, PhD

  Radboudumc Nijmegen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: March 9, 2020
• Study Start: September 1, 2020
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)