Technetium Based Radioguided Surgery for Prostate Cancer (TRACE) Study

Netherlands Cancer Institute (NKI)

Status

Unknown

Conditions

Prostate Cancer

Treatments

Procedure: PSMA-radioguided surgery

Study type

Observational

Funder types

Other

Identifiers

NCT03857113

M19TRA

Details and patient eligibility

About

PSMA-radioguided surgery

Full 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.

Enrollment

20 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.