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

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

PSMA-radioguided surgery

Study Overview

• Status: Unknown
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: PSMA-radioguided surgery

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: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1066CX
      • Recruiting
      • AVL
      • Contact: Pim van Leeuwen, MD, PhD; Phone Number: +31205129111; Email: pj.v.leeuwen@nki.nl
      • Contact: Maarten Donswijk; Phone Number: +31205127473; Email: m.donswijk@nki.nl
      • Principal Investigator: Pim van Leeuwen, MD, PhD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
sensibility of 99mTc-PSMA Radioguided surgery in lymph node dissection	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

• Sponsor: The Netherlands Cancer Institute
• Investigators: Principal Investigator: Pim van Leeuwen, MD, PHD, NKI-AvL

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2020
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: November 19, 2018
• First Submitted That Met QC Criteria: February 26, 2019
• First Posted (Actual): February 27, 2019

Study Record Updates

• Last Update Posted (Actual): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 20, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID 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