Clinical trial · Interventional
Dual PSMA and FDG PET Imaging for Patients With Advanced Prostate Cancer
NCT06335914CI-TRIAL-00103148recruitingN/AClinicalTrials.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)
This study will use Prostate Specific Membrane Antigen (PSMA) and (18)F-Fluorodeoxyglucose Positron Emission Tomography (FDG PET) imaging in patients with advanced prostate cancer to learn about tumor biology across disease stages and during treatment. This may help with treatment selection and potential response monitoring in the future.
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 |
|---|---|---|---|
| Advanced Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-DCFPyL PET | Diagnostic Test | — | UNRESOLVED |
| FDG PET | Diagnostic Test | — | UNRESOLVED |
| Ga 68 PSMA-11 PET | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PSMA and FDG PET Imaging
- description
- Participants advanced prostate cancer will undergo PSMA and FDG PET prior to starting their standard of care treatment and during treatment.
- interventionNames
- Diagnostic Test: Ga 68 PSMA-11 PET
- Diagnostic Test: 18F-DCFPyL PET
- Diagnostic Test: FDG PET
Primary outcomes (1)
- measure
- Proportion of patients with high volume mCSPC having PSMA avid disease
- timeFrame
- 5 years
Secondary outcomes (1)
- measure
- Proportion of patients with PSMA-/FDG+ discordant lesions
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male, age ≥ 18 years * Histologically or cytologically confirmed prostate cancer (adenocarcinoma) * Poor risk patients with mCSPC at study enrollment * De novo or recurrent high volume mCSPC as per conventional imaging (CT chest abdomen pelvis, or MRI, plus bone scan) prior to starting ADT and ARPI * High or low volume mCSPC plus PSA ≥4.0 after 6-8 months of initiating ADT * Willing to undergo study PET scans and remain under the care of medical oncology, radiation oncology or urology physician at Princess Margaret Cancer Center. * No prior PSMA or FDG PET imaging within the last 60 days at each specified time point on study * Patients enrolled in clinical trials are eligible if they satisfy all other criteria of eligibility Exclusion Criteria: * Under a randomized-controlled trial with unknown allocation of systemic therapy * Inability to undergo or successfully complete PSMA PET and FDG PET imaging exams * Unable to provide written consent by patient and their legal representatives * In the opinion of the treating physician: * conditions which would significantly impair the patient's ability to comply with study procedures and follow up * Significant uncontrolled comorbidity, which may negatively impact the safety or interpretability of study PET imaging * another active malignancy * patient on dialysis * another radioisotope or investigational systemic agent within 5 half-lives prior to PET imaging
References
Publications (0)
Data not yet available
No reference posted for this study.