Clinical trial · Interventional
Two TraCer PositROn EmiSSion Tomography ComBination for Efficacy EstimatiOn of Prostate Specific Membrane Antigen Radioligand Therapy in Patients With Metastatic Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Drug no longer available
Summary
Brief summary (as posted)
Single-arm, open-label, phase II trial in 200 competent adult male patients with Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-3 and progressive metastatic prostate cancer, failing, failed, refused, not eligible for or no access to further approved lines of therapy. Patients will undergo sequential FDG positron emission tomography (PET) and 18F-DCFPyL PET to assess FDG/DCFPyL concordance fraction. Patients with DCFPyL/FDG concordance of 50% or greater will be treated with 131I-PSMA-1095 radioligand therapy (RLT). Best post-treatment serum prostate specific antigen response will be compared to concordance fraction.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Prostate Carcinoma in the Soft Tissue | — | UNRESOLVED | — |
| Metastatic Prostatic Adenocarcinoma | — | UNRESOLVED | — |
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 131I-PSMA-1095 Radioligand Therapy (RLT) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 131I-PSMA-1095 Radioligand Therapy (RLT)
- description
- Intravenous injection of 100 mCi of 131I-PSMA-1095 RLT, Q8 weeks up to a maximum of 4 doses
- interventionNames
- Drug: 131I-PSMA-1095 Radioligand Therapy (RLT)
Primary outcomes (1)
- measure
- Serum prostate specific antigen (PSA)
- timeFrame
- 3 months post last dose of RLT
- description
- The best serum prostate specific antigen (PSA) response will be calculated for each patient as: pre-treatment PSA minus lowest post-treatment PSA divided by pre-treatment PSA. Best PSA response will be reported as percent reduction (or increase) from baseline.
Secondary outcomes (1)
- measure
- Adverse events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male * Age 18 years or older * Documented metastatic adenocarcinoma of the prostate * Under active medical oncology care * ECOG performance status 0 - 3, inclusive * Able to understand and provide written informed consent * Able to tolerate the physical requirements of two PET/CT scans including lying for up to 30 minutes * Progressive disease on any of: bone scan, CT, MRI or serum PSA as judged by the investigator * Serum prostate specific antigen ≥ 1 ng/ml at baseline or CT/MRI soft-tissue measurable disease as per RECIST v1.1 * Failed, failing, refused, no access to or not eligible for any approved prostate cancer therapies including but not limited to: ADT, NAAD (e.g., abiraterone, enzalutamide, darolutamide or apalutamide), docetaxel, cabazitaxel, radium-223 and oligometastatic RTX * Life expectancy of at least 3 months as judged by the investigator Exclusion Criteria: * Medically unstable (e.g. acute cardiac or respiratory distress or hypotensive) * Exceeding the weight limit of the PET/CT bed (approximately 400 lbs.) or who cannot fit through the PET/CT bore (approximately 70 cm diameter) * Unmanageable claustrophobia * Prior failure of PSMA RLT * Prior hemi-body irradiation * Impaired organ function as evidenced by any of the following laboratory values: * Absolute neutrophil count \< 1.5 x109/L * Platelet count \< 75 x109/L * Hemoglobin \< 85 g/L * Albumin \< 2.5 g/dL (25 g/L) * Total bilirubin \> 2 x ULN (unless in instances of Gilbert's disease) * AST or ALT \> 2.5 x ULN (or \> 5.0 x ULN in the presence of liver metastases)
References
Publications (0)
Data not yet available