Clinical trial · Observational
Technetium Based Radioguided Surgery for Prostate Cancer (TRACE) Study
99mTechnetium Based PSMA-Radioguided Assisted Surgery for Prostate Cancer (TRACE) Feasibility Study
NCT03857113CI-TRIAL-00046106TRACEunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
PSMA-radioguided surgery
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PSMA-radioguided surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- PSMA-radioguided surgery
- description
- Tc-99m-PSMA combined with a gamma probe, guidance of the surgical resection of recurrent PC lymph node metastases
- interventionNames
- Procedure: PSMA-radioguided surgery
Primary outcomes (1)
- measure
- sensibility of 99mTc-PSMA Radioguided surgery in lymph node dissection
- timeFrame
- through study completion, an average of two days
- description
- sensibility of 99mTc-PSMA-I\&S by calculating the percentage of PSMA avid lymph nodes
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.