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Technetium Based Radioguided Surgery for Prostate Cancer (TRACE) Study

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03857113
Acronym
TRACE
Enrollment
20
Registered
2019-02-27
Start date
2020-03-11
Completion date
2022-03-01
Last updated
2020-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Brief summary

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.

Interventions

PSMA-radioguided surgery

Sponsors

The Netherlands Cancer Institute
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
sensibility of 99mTc-PSMA Radioguided surgery in lymph node dissectionthrough study completion, an average of two dayssensibility of 99mTc-PSMA-I&S by calculating the percentage of PSMA avid lymph nodes

Countries

Netherlands

Contacts

Primary ContactPim van Leeuwen, MD, PhD
pj.v.leeuwen@nki.nl0205129111
Backup ContactMaarten Donswijk
m.donswijk@nki.nl+31 20 5127473

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026