Clinical trial NCT04300673: Radio Guided Lymph Node Dissection in Oligometastatic Prostate Cancer Patients
Official title: Radio Guided Lymph Node Dissection in Oligometastatic Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Lymph Node Metastases
Keywords: pelvic lymph node dissection (PLND)
PSMA I&T
radio guided surgery (RGS)
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2020-03-09
Enrollment: 20
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

  1. Pelvic surgery is defined as "any surgery associated with pelvic lymphadenopathy'.
  2. 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.

Primary outcomes:
measure: Feasibility of 111In-PSMA-I&T radio guided surgery
timeFrame: 1 year
Secondary outcomes:
measure: The accuracy of 111In-PSMA-I&T radio guided surgery
timeFrame: 1 year
measure: The safety of 111In-PSMA-I&T
timeFrame: 1 year
measure: Dosimetry of 111In-PSMA-I&T
timeFrame: 1 year
measure: Correlation between tracer accumulation and lymph node size, PSMA-staining and SUV on PSMA-PET/CT
timeFrame: 1 year
measure: Correlation between post-operative nano-MRI and SPECT
timeFrame: 1 year
measure: Correlation between pre-operative imaging and postoperative imaging
timeFrame: 2 years
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelimina Ziekenhuis
Study officials:
affiliation: Radboudumc Nijmegen
name: Michiel Sedelaar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: