Technetium Based Radioguided Surgery for Prostate Cancer (TRACE) Study

Prostate Cancer Clinical Trial

— TRACE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03857113
• Other study ID #: M19TRA
• Status: Recruiting
• Start date: March 11, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: July 2020
• Source: The Netherlands Cancer Institute
• Contact: Pim van Leeuwen, MD, PhD
• Phone: 0205129111
• Email: pj.v.leeuwen[@]nki.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

PSMA-radioguided surgery

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 information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• PSMA-radioguided surgery
PSMA-radioguided surgery

Locations

Country	Name	City	State
Netherlands	AVL	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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