EUCTR2020-000121-37-FR
Active, not recruiting
Phase 1
A Prospective Study on 18F-DCFPyL PET/CT Imaging in Biochemical Recurrence of Prostate Cancer - PYTHO
CYCLOPHARMA0 sites217 target enrollmentFebruary 20, 2020
ConditionsPatients with histopathologically confirmed prostate adenocarcinoma per original diagnosis and subsequent definitive therapy, with first biochemical recurrenceMedDRA version: 21.0Level: PTClassification code 10036911Term: Prostate cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with histopathologically confirmed prostate adenocarcinoma per original diagnosis and subsequent definitive therapy, with first biochemical recurrence
- Sponsor
- CYCLOPHARMA
- Enrollment
- 217
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •2\. Age superior or equal to 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 43
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 ongoing
- •7\. Unable to lie supine for imaging
- •8\. Known allergy to investigational or reference products or to any excipients
- •9\. Unable to provide written consent (linguistic or psychological inability)
- •10\. Participation in another clinical study within one month prior to inclusion
Outcomes
Primary Outcomes
Not specified
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