Status:
UNKNOWN
Technetium Based Radioguided Surgery for Prostate Cancer (TRACE) Study
Lead Sponsor:
The Netherlands Cancer Institute
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 11 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03857113
Start Date
March 11 2020
End Date
March 1 2022
Last Update
July 22 2020
Active Locations (1)
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1
AVL
Amsterdam, North Holland, Netherlands, 1066CX