Technetium Based Radioguided Surgery for Prostate Cancer (TRACE) Study

Study Overview
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Brief Summary
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PSMA-radioguided surgery

Detailed Description
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: PSMA-radioguided surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PSMA-radioguided surgery<br>Tc-99m-PSMA combined with a gamma probe, guidance of the surgical resection of recurrent PC lymph node metastases | Procedure: PSMA-radioguided surgery<br>* PSMA-radioguided surgery<br>|

What is the study measuring?
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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 |