Clinical trial · Interventional
Metabolic Change in Prostate Cancer Bone Metastases on 68Ga-HBED-CC-PSMA PET/CT Following Radium-223 Therapy
NCT03062254CI-TRIAL-00054002completedPhase 2ClinicalTrials.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)
Broadly, the objective of this study is to evaluate the fractional decline of intensity of tracer uptake measured by SUVmax on 68Ga-PSMA PET/CT in bone metastases from prostate cancer following treatment with radium-223 as a surrogate marker for tumor cell killing.
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 |
|---|---|---|---|
| radium-223 dichloride | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radium-223
- interventionNames
- Drug: radium-223 dichloride
Primary outcomes (1)
- measure
- SUV-max
- timeFrame
- 6 months
- description
- fractional decline of intensity of tracer uptake measured by SUVmax on 68Ga-PSMA PET/CT
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria * Resident of Canada * Male sex * Age 18 years or older * Progressive (symptoms, conventional imaging, PSA, bone scan, FCH PET/CT or other) castration-resistant prostate cancer in the judgment of the treating physician without change in systemic anti-neoplastic therapy since documented progression * Six or greater bone metastases robustly-avid on recent (4 weeks) MDP or NaF scintigraphy * Recently failed (within 3 months) or failing novel androgen receptor pathway inhibitors (abiraterone + prednisone or enzalutamide) with intention of continuing the drug for at least 7 months OR minimum 14 day washout period from either agent prior to study enrollment * No known visceral metastases or adenopathy greater than 3 cm short axis on conventional imaging * Not received docetaxel for castration-resistant disease * ECOG performance status 0 - 2, inclusive * Life expectancy of greater than 6 months * Serum testosterone less than or equal to 50 ng/dl * Hemoglobin greater than or equal to 100 g/L with no blood transfusions or EPO in preceding 3 weeks * Neutrophils greater than or equal to 1.5 x109/L * Platelets greater than or equal to 100 x109/L * No prior hemi-body radiotherapy * No impending or established spinal cord compression * No unmanageable fecal incontinence * Patient has good IV access * Able to understand and provide written informed consent Exclusion Criteria * Planned change in systemic anti-neoplastic therapy during the approximately 7 month trial * Unable to tolerate the physical/logistical requirements of a PET/CT scan including lying supine for up to 30 minutes with the arms above the head and tolerating intravenous cannulation for injection of the study drug. * Medically unstable patients (e.g. acute cardiac or respiratory distress or hypotensive, etc.) * Patients who exceed the safe weight limit of the PET/CT bed (approximately 400 lbs.) or who cannot fit through the PET/CT bore (70 cm diameter) * Patients who are claustrophobic
References
Publications (0)
Data not yet available
No reference posted for this study.