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Radio Guided Lymph Node Dissection in Oligometastatic Prostate Cancer Patients (DETECT)

Primary Purpose

Prostate Cancer, Lymph Node Metastases

Status
Active
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
Radio guided surgery (RGS) using Indium-labelled PSMA
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring pelvic lymph node dissection (PLND), PSMA I&T, radio guided surgery (RGS)

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Radboudumc
  • Canisius Wilhelimina Ziekenhuis

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All patients

Arm Description

Intervention: radio guided surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The accuracy of 111In-PSMA-I&T radio guided surgery
Accuracy will be expressed as sensitivity and specificity percentage. Test results of gamma probe (positive or negative) will be compared with histopathology (gold standard) (positive or negative: i.e. containing PSMA-expressing prostate cancer cells).
The safety of 111In-PSMA-I&T
Safety will be assesed by the number of participants with treatment related adverse events as assessed by CTCAE v4.0. For this outcome measure extra bloodsampling is included in the study protocol.
Dosimetry of 111In-PSMA-I&T
Blood-clearance ratios will be determined based on radiation dosimetry as assessed by bloodsampling at set time points after injection.
Correlation between tracer accumulation and lymph node size, PSMA-staining and SUV on PSMA-PET/CT
Correlation between post-operative nano-MRI and SPECT
Correlation between pre-operative imaging and postoperative imaging

Full Information

First Posted
February 17, 2020
Last Updated
April 27, 2022
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04300673
Brief Title
Radio Guided Lymph Node Dissection in Oligometastatic Prostate Cancer Patients
Acronym
DETECT
Official Title
Radio Guided Lymph Node Dissection in Oligometastatic Prostate Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Lymph Node Metastases
Keywords
pelvic lymph node dissection (PLND), PSMA I&T, radio guided surgery (RGS)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All patients
Arm Type
Experimental
Arm Description
Intervention: radio guided surgery
Intervention Type
Procedure
Intervention Name(s)
Radio guided surgery (RGS) using Indium-labelled PSMA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of 111In-PSMA-I&T radio guided surgery
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The accuracy of 111In-PSMA-I&T radio guided surgery
Description
Accuracy will be expressed as sensitivity and specificity percentage. Test results of gamma probe (positive or negative) will be compared with histopathology (gold standard) (positive or negative: i.e. containing PSMA-expressing prostate cancer cells).
Time Frame
1 year
Title
The safety of 111In-PSMA-I&T
Description
Safety will be assesed by the number of participants with treatment related adverse events as assessed by CTCAE v4.0. For this outcome measure extra bloodsampling is included in the study protocol.
Time Frame
1 year
Title
Dosimetry of 111In-PSMA-I&T
Description
Blood-clearance ratios will be determined based on radiation dosimetry as assessed by bloodsampling at set time points after injection.
Time Frame
1 year
Title
Correlation between tracer accumulation and lymph node size, PSMA-staining and SUV on PSMA-PET/CT
Time Frame
1 year
Title
Correlation between post-operative nano-MRI and SPECT
Time Frame
1 year
Title
Correlation between pre-operative imaging and postoperative imaging
Time Frame
2 years

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Study concerns prostate cancer patients.
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michiel Sedelaar, MD, PhD
Organizational Affiliation
Radboudumc Nijmegen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboudumc
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525
Country
Netherlands
Facility Name
Canisius Wilhelimina Ziekenhuis
City
Nijmegen
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

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Radio Guided Lymph Node Dissection in Oligometastatic Prostate Cancer Patients

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