Technetium Based Radioguided Surgery for Prostate Cancer (TRACE) Study (TRACE)

July 20, 2020 updated by: The Netherlands Cancer Institute

99mTechnetium Based PSMA-Radioguided Assisted Surgery for Prostate Cancer (TRACE) Feasibility Study

PSMA-radioguided surgery

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Given the difficulty visualizing lymph node involvement with pre-operative imaging alone, and the potential to miss metastatic nodal involvement on template PLND, radioguided surgery has been proposed as a technique to improve intra-operative detection and clearance. 99mTechnetium (99mTc) is a frequently used radioisotope in nuclear medicine, with favourable radiation properties and commercial availability[11]. It has a 6-hour half-life, and is suited to allow target tissue accumulation, while minimizing patients and investigator radiation exposure. Novel molecule-targeted radiopharmaceuticals using 99mTC and other radioisotopes in the setting of PC have increasing potential for diagnostic imaging, monitoring of therapeutic interventions and directed surgery[11, 12]. In relation to radioguided surgery, 99mTC -based PSMA-radioguided surgery (99mTc-PSMA-RGS) was deployed in a feasibility study. Using a specifically designed 99mTc based tracer, 99mTc-mas3-y-nal-k(Sub-KuE), or in short Tc-99m-PSMA I&S, combined with a gamma probe, guidance of the surgical resection of recurrent PC lymph node metastases was undertaken in 132 patients, yielding a sensitivity of 84% and specificity of 100% and detecting metastases as small as 3mm[15, 16]. This raises the question as to whether a combination of PSMA PET/CT imaging and PSMA-radioguided surgery may increase the cure rate in patients undergoing operative management of PC, by increasing detection sensitivity and specificity of nodal metastases.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1066CX
        • Recruiting
        • AVL
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pim van Leeuwen, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

men with hormone-sensitive recurent prostate cancer

Description

Inclusion Criteria:

  • Male, aged ≥ 18 years.
  • Hormone-sensitive recurrent prostate cancer after radical prostatectomy
  • <3 soft tissue lesions (lymph node; connective tissue) within the pelvis or retroperitoneum with sufficient PSMA expression (≥3 times regional vascular activity level) as determined by PSMA-based PET
  • PSA-value <4ng/mL
  • Had a PSMA PET/CT within 60 days before surgery
  • Suitable for salvage lymph node dissection, as per institutional guidelines.
  • WHO performance status 0,1, or 2.
  • Written informed consent.

Exclusion Criteria:

  • Suspicion of local recurrent prostate cancer within the prostatic fossa not treatable by surgery
  • Nonregional lymphadenopathy (cM1a) or distant metastases (cM1b/c) as assessed by preoperative PSMA PET/CT.
  • Ongoing androgen deprivation therapy (ADT) or within 6 months prior to surgery.
  • Severe claustrophobia interfering with PET/CT or SPECT/CT scanning.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PSMA-radioguided surgery
Tc-99m-PSMA combined with a gamma probe, guidance of the surgical resection of recurrent PC lymph node metastases
Procedure: PSMA-radioguided surgery
PSMA-radioguided surgery

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
sensibility of 99mTc-PSMA Radioguided surgery in lymph node dissection
Time Frame: through study completion, an average of two days
sensibility of 99mTc-PSMA-I&S by calculating the percentage of PSMA avid lymph nodes
through study completion, an average of two days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Netherlands Cancer Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pim van Leeuwen, MD, PHD, NKI-AVL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 11, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M19TRA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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