EUCTR2021-001123-40-NL
Active, not recruiting
Phase 1
18F-fluciclovine PET/CT and 18F-DCFPyL PET/CT in patients with biochemical recurrence of disease after radical prostatectomy: a prospective, single-centre, single-arm, comparative imaging trial - RENARD trial
Amsterdam UMC, VU University Medical Center0 sites50 target enrollmentApril 22, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Amsterdam UMC, VU University Medical Center
- Enrollment
- 50
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \= 18 years.
- •Histopathological confirmed prostate adenocarcinoma per original diagnosis.
- •History of RARP.
- •Biochemical recurrence of prostate cancer based on two consecutive measurable PSA levels of 0\.2 \-2\.0 ng/mL.
- •Ability to understand and sign the written informed consent form.
- •Patients who can undergo all study procedures per investigator’s point of view.
- •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 20
Exclusion Criteria
- •Another active malignant tumor, except skin basal cell carcinoma.
- •pN1 disease after ePLND.
- •Any change in prostate cancer treatment between both PET/CT scans.
- •History of previous salvage therapies (including salvage radiotherapy or salvage lymph node dissection).
- •History of salvage radiotherapy of the prostate bed.
- •History of cryotherapy, high\-intensity focused ultrasound (HIFU).
- •Treatment with androgen deprivation therapy (ADT) in the past 30 days or ongoing.
- •Unable to lie supine or still for imaging.
- •Known allergy to investigational or reference products or to any excipients.
- •Unable to provide written consent (linguistic or psychological inability).
Outcomes
Primary Outcomes
Not specified
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