Technetium Based Radioguided Surgery for Prostate Cancer (TRACE) Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-11

Study Completion Date

2022-03-01

Brief Summary

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PSMA-radioguided surgery

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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.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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PSMA-radioguided surgery

Tc-99m-PSMA combined with a gamma probe, guidance of the surgical resection of recurrent PC lymph node metastases

PSMA-radioguided surgery

Intervention Type PROCEDURE

PSMA-radioguided surgery

Interventions

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PSMA-radioguided surgery

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No