Clinical trial · Interventional
Advanced Prostate Imaging of Recurrent Cancer After Radiotherapy
- 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)
The investigators are attempting to determine if a new form of imaging called 18F-DCFPyL PET/CT is helpful to physicians in deciding how to manage suspected prostate cancer recurrence. This imaging uses a Positron Emission Tomography/Computed Tomography (PET/CT) scan using a radioactive tracer 18F-DCFPyL that is concentrated in prostate cancer cells and can potentially identify cancer cells throughout the body. The combination of 18F-DCFPyL PET/CT can potentially identify areas of prostate cancer recurrence not seen with usual imaging \[bone scan, computed tomography (CT) thorax, abdomen and pelvis, plus multi-parametric magnetic resonance imaging (MRI)\].
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 |
|---|---|---|---|
| 18F-DCFPyL PET/CT scan | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention 18F-DCFPyL PET/CT
- description
- 18F-DCFPyL PET/CT scan obtained at the time of restaging for biochemical recurrence after primary radiotherapy
- interventionNames
- Radiation: 18F-DCFPyL PET/CT scan
Primary outcomes (1)
- measure
- Detection of extra-prostatic disease
- timeFrame
- 2 weeks post re-staging
- description
- Number of men with extra-prostatic disease detected by either 18F-DCFPyL PET/CT or conventional imaging, divided by the number of men undergoing imaging.
Secondary outcomes (8)
- measure
- Detection of extra-prostatic disease exclusive to 18F-DCFPyl PET/CT
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Previous external beam radiotherapy or brachytherapy for localized disease (T1-T2, Gleason \< 7 and PSA \< 20) or (T1-2, Gleason 8, prostatic specific antigen (PSA)\<10) * Interval to biochemical failure more than 12 months from last radical therapeutic intervention * Biochemical failure confirmed on at least 3 consecutive PSA measurements each taken at least 1 month apart * PSA at time of enrollment more than nadir+2.0ng/ml (Phoenix definition of biochemical failure) * Karnofsky performance status 70 or better \[Eastern Cooperative Oncology Group (ECOG) 0,1\] * Total serum testosterone level \>1nmol/l (if prior treatment with hormone therapy) Exclusion Criteria: * CT or bone scan within 6 months of enrollment * Patients whose prior radiotherapy was delivered with palliative intent * Patients with known metastatic disease * Extensive co-morbidities precluding potential ablative salvage procedures * Prior history of invasive non-cutaneous malignant disease unless disease free for at least 5 years * Already on systemic anticancer treatment (androgen deprivation or chemotherapy) * Inability to comply with the imaging requirements e.g. inability to lie supine for one hour * Allergy or contraindication to MRI or CT contrast agents or PET tracer to be used as part of the imaging * Insufficient renal function \[estimated glomerular filtration rate (eGFR) \< 30 mL/min\]
References
Publications (0)
Data not yet available