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PSMA-radioguided surgery
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PSMA-radioguided surgery | Tc-99m-PSMA combined with a gamma probe, guidance of the surgical resection of recurrent PC lymph node metastases |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PSMA-radioguided surgery | Procedure | PSMA-radioguided surgery |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
men with prostate cancer
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men with hormone-sensitive recurent prostate cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pim van Leeuwen, MD, PhD | Contact | 0205129111 | pj.v.leeuwen@nki.nl | |
| Maarten Donswijk | Contact | +31 20 5127473 | m.donswijk@nki.nl |
| Name | Affiliation | Role |
|---|---|---|
| Pim van Leeuwen, MD, PHD | NKI-AvL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AVL | Recruiting | Amsterdam | North Holland | 1066CX | Netherlands |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |