Clinical trial · Interventional
Assessment of New Molecular Imaging Strategies for Prostate Cancer
Assessment of New Molecular Imaging Strategies for Prostate Cancer: Predictive Value of Established and Novel Positron Emission Tomography (PET) Radiotracers in Castration-Resistant 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)
In this study 30 men, with advanced metastatic Castration-Resistant Prostate Cancer (CRPC) planned to have hormonal treatment, will undergo conventional imaging and functional imaging prior to treatment and post treatment to determine if changes in imaging results will be prognostic of outcome. Patients will have a clinical follow-up every 3 months post randomization for one year and followed for survival at Years 2 and 3.
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 |
|---|---|---|---|
| Molecular Imaging | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Imaging
- description
- Molecular Imaging
- interventionNames
- Other: Molecular Imaging
Primary outcomes (1)
- measure
- Functional imaging metabolic response contrasted with conventional imaging response
- timeFrame
- 10 weeks
- description
- Percent change of the average maximum standardized uptake value (SUVmax) of target lesions in contrast with conventional imaging soft tissue and bone response between the baseline scans and the Week 10 scans.
Secondary outcomes (5)
- measure
- Functional imaging response
- timeFrame
- 10 weeks
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Objectively documented metastatic prostate cancer progression with either of the following: * At least one rising PSA over a minimum of one week interval within six weeks of study registration, or * Radiographic progression in soft tissue and/or bone within six weeks of study registration 2. Ongoing androgen deprivation therapy with serum testosterone \<50 ng/dL (\<1.7 nmol/L). 3. Planned to start abiraterone acetate or enzalutamide. Exclusion Criteria: 1. Age \< 18 years. 2. Eastern Cooperative Oncology Group (ECOG) performance status \>2. 3. Planned to receive palliative radiotherapy within the next 12 weeks. 4. Hemoglobin \< 90 g/L independent of transfusion. 5. Platelet count \< 50 x 10\^9 / L. 6. Serum albumin \< 30 g/L. 7. Serum creatinine \> 1.5 x Upper Limit of Normal (ULN) or a calculated creatinine clearance \<30 L/min. 8. Contraindications to FDG. 9. Inability to lie supine for imaging with PET-CT. 10. Inability to undergo CT due to known allergy to contrast. 11. Inadequate hepatic function: (i) Bilirubin \>1.5 x ULN, and (ii) Serum glutamic oxaloacetic transaminase (SGOT) \>3 x ULN 12. Inability to complete the study or required follow-up
References
Publications (0)
Data not yet available