Clinical trial · Interventional
Study of TRDC002 in the Diagnosis of Patients With PSMA-positive Prostate Cancer
A Prospective, Randomized, Open-label, Phase I Study of TRDC002 in the Diagnosis of Patients With PSMA-positive Recurrent or Metastatic Prostate Cancer
- 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)
TRDC002 uses a radioactive form (64Cu) to trace the PSMA positive prostate cancer. The purpose of this study is to investigate TRDC002 as a PSMA PET tracer to localize PSMA positive lesions in adult patients with recurrent or metastatic prostate cancer. We plan to assess the PSMA PET/CT image quality following administration of two dose levels of TRDC002 to determine an acceptable dose and optimal acquisition time for obtaining diagnostic quality PET/CT images. The safety and tolerability, PK, biodistribution, dosimetry of TRDC002 will also be evaluated in this study.
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 |
|---|---|---|---|
| Intravenous (IV) single dose | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 4 mCi of TRDC002
- description
- Patients receive 4±0.5mCi (148±18.5 MBq) of TRDC002 IV. Patients then undergo PET/CT scan.
- interventionNames
- Drug: Intravenous (IV) single dose
- type
- EXPERIMENTAL
- label
- 6 mCi of TRDC002
- description
- Patients receive 6±0.5mCi (222±18.5 MBq) of TRDC002 IV. Patients then undergo PET/CT scan.
- interventionNames
- Drug: Intravenous (IV) single dose
Primary outcomes (1)
- measure
- the safety and tolerability of TRDC002 in participants
- timeFrame
- 3 days
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants with recurrence or metastasis of prostate cancer. * Participants with PSMA-positive lesions. * Participants must have adequate bone marrow and organ function. * Participants with an ECOG performance status of 0 or 1. Exclusion Criteria: * Any immunotherapy or biological therapy (including antibodies) targeting PSMA within 60 days prior to the day of randomization. * A superscan is observed in the baseline bone scan. * Concurrent serious (as determined by the Investigator) medical conditions * Participants with symptomatic brain metastases, meningeal metastases, or spinal cord compression.
References
Publications (0)
Data not yet available