NL-OMON55231
Completed
Phase 3
A Prospective Study on 18F-DCFPyL PET/CT Imaging in Biochemical Recurrence of Prostate Cancer - PYTHO
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Biochemical recurrent prostate cancer
- Sponsor
- Curium PET France
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •2\. Age \* 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
- •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
Exclusion Criteria
- •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
- •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
Outcomes
Primary Outcomes
Not specified
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