Status:
UNKNOWN
A Prospective Study on 18F-DCFPyL PET/CT Imaging in Biochemical Recurrence of Prostate Cancer
Lead Sponsor:
Curium PET France
Conditions:
Prostate Cancer Recurrent
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
The primary objective is the per-patient detection rate of 18F-DCFPyL in comparison with 18F-Fluorocholine. Secondary objectives include the assessment of the impact on patient treatment management, t...
Eligibility Criteria
Inclusion
- Male.
- Age min 18 years.
- Histopathological proven prostate adenocarcinoma per original diagnosis.
- 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.
- Able and willing to provide informed consent and comply with protocol requirements
- Patient who can undergo all study procedures per Investigator's point of view
- Patient with social insurance cover.
Exclusion
- Patients displaying any of the following criteria will not be included:
- ECOG \> 2
- History of previous salvage therapies (including salvage radiotherapy or salvage lymph node dissection)
- History of adjuvant radiotherapy
- History of cryotherapy, high-intensity focused ultrasound (HIFU)
- Other active malignant tumour
- Treatment with Androgen Deprivation Therapy (ADT) in the past 30 days or ongoing
- Treatment with colchicine in the past 8 days or ongoing
- Treatment with hematopoietic colony stimulating factors (CSF) in the past 5 days or ongoing
- Unable to lie supine for imaging
- Known allergy to investigational or reference products or to any excipients
- Unable to provide written consent (linguistic or psychological inability)
- Participation in another clinical study within one month prior to inclusion
- Uncooperative, in the Investigator's opinion.
- Subjects deprived of their freedom by administrative or legal decision or who are under guardianship
Key Trial Info
Start Date :
July 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2022
Estimated Enrollment :
217 Patients enrolled
Trial Details
Trial ID
NCT04734184
Start Date
July 7 2020
End Date
February 1 2022
Last Update
February 2 2021
Active Locations (1)
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1
CURIUM PET France
Saint-Beauzire, France, 63360