Technetium Based Radioguided Surgery for Prostate Cancer (TRACE) Study
TRACE
99mTechnetium Based PSMA-Radioguided Assisted Surgery for Prostate Cancer (TRACE) Feasibility Study
1 other identifier
observational
20
1 country
1
Brief Summary
PSMA-radioguided surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2018
CompletedFirst Posted
Study publicly available on registry
February 27, 2019
CompletedStudy Start
First participant enrolled
March 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedJuly 22, 2020
July 1, 2020
2 years
November 19, 2018
July 20, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
PSMA-radioguided surgery
Tc-99m-PSMA combined with a gamma probe, guidance of the surgical resection of recurrent PC lymph node metastases
Interventions
Eligibility Criteria
men with hormone-sensitive recurent prostate cancer
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AVL
Amsterdam, North Holland, 1066CX, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pim van Leeuwen, MD, PHD
NKI-AvL
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2018
First Posted
February 27, 2019
Study Start
March 11, 2020
Primary Completion
March 1, 2022
Study Completion
March 1, 2022
Last Updated
July 22, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share