Technetium Based Radioguided Surgery for Prostate Cancer (TRACE) Study
- Conditions
- Prostate Cancer
- Interventions
- Procedure: PSMA-radioguided surgery
- Registration Number
- NCT03857113
- Lead Sponsor
- The Netherlands Cancer Institute
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 20
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description PSMA-radioguided surgery PSMA-radioguided surgery Tc-99m-PSMA combined with a gamma probe, guidance of the surgical resection of recurrent PC lymph node metastases
- Primary Outcome Measures
Name Time Method sensibility of 99mTc-PSMA Radioguided surgery in lymph node dissection through study completion, an average of two days sensibility of 99mTc-PSMA-I\&S by calculating the percentage of PSMA avid lymph nodes
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
AVL
🇳🇱Amsterdam, Noord-Holland, Netherlands