Clinical trial · Interventional
A Prospective Study on 18F-DCFPyL PET/CT Imaging in Biochemical Recurrence of Prostate Cancer
Title A Prospective Study on 18F-DCFPyL PET/CT Imaging in Biochemical Recurrence of 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)
PYTHON is designed to establish the efficacy and safety of 18F-DCFPyL in comparison with that of 18F-fluorocholine, in patients with first biochemical recurrence (BCR) after initial definitive therapy (prostatectomy, external beam radiotherapy or brachytherapy) for histopathologically confirmed prostate adenocarcinoma per original diagnosis. PET/CT scans will be each interpreted by three independent masked experts who are not otherwise involved in the trial.
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 Recurrent | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DCFPyL | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- to compare per-patient detection rate of 18F-DCFPyL PET/CT versus that of 18F-FCH PET/CT.
- timeFrame
- 10 weeks
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male. 2. Age min 18 years. 3. Histopathological proven prostate adenocarcinoma per original diagnosis. 4. First suspected recurrence of prostate cancer based on rising prostate-specific antigen (PSA) after initial curative therapy with radical prostatectomy of PSA ≥ 0.2 ng/mL confirmed by a subsequent PSA value of ≥0.2 ng/mL or with radiation therapy (external beam or brachytherapy) of PSA \> 2 ng/mL above the nadir after therapy regardless of the serum concentration of the nadir. 5. Able and willing to provide informed consent and comply with protocol requirements 6. Patient who can undergo all study procedures per Investigator's point of view 7. Patient with social insurance cover. Exclusion Criteria: Patients displaying any of the following criteria will not be included: 1. ECOG \> 2 2. History of previous salvage therapies (including salvage radiotherapy or salvage lymph node dissection) 3. History of adjuvant radiotherapy 4. History of cryotherapy, high-intensity focused ultrasound (HIFU) 5. Other active malignant tumour 6. Treatment with Androgen Deprivation Therapy (ADT) in the past 30 days or ongoing 7. Treatment with colchicine in the past 8 days or ongoing 8. Treatment with hematopoietic colony stimulating factors (CSF) in the past 5 days or ongoing 9. Unable to lie supine for imaging 10. Known allergy to investigational or reference products or to any excipients 11. Unable to provide written consent (linguistic or psychological inability) 12. Participation in another clinical study within one month prior to inclusion 13. Uncooperative, in the Investigator's opinion. 14. Subjects deprived of their freedom by administrative or legal decision or who are under guardianship
References
Publications (0)
Data not yet available