A prospective imaging study with 18F-fluciclovine PET/CT and 18F-DCFPyL in patients with biochemical reccurence of prostate cancer.

Phase 1

• Conditions: Prostate cancer; MedDRA 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]

• Registration Number: EUCTR2021-001123-40-NL
• Lead Sponsor: Amsterdam UMC, VU University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-22
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

Male.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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).
Uncooperative, in the Investigator’s opinion.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To head-to-head compare the imaging performance of 18F-fluciclovine PET/low-dose CT and 18F-DCFPyL PET/low-dose CT in patients with BCR of PCa after radical prostatectomy.;Primary end point(s): 1.To compare the per patient detection rates (i.e., the proportion of patients with PET-positive findings) of 18F-fluciclovine (reference test) versus 18F-DCFPyL PET/CT (index test) for the identification of tumour location(s) patients with BCR of disease after RARP (PSA <0.2). ;Timepoint(s) of evaluation of this end point: We expect to complete the patient inclusion in 9 months. Data analysis and document writing will require 2-3 months. ;Secondary Objective: 1.the detection rates on a patient-based analysis of 18F-DCFPyL and 18F-fluciclovine PET/CT stratified by PSA level (0.2-0.5; 0.51-1.0; 1.01-2.0 ng/mL);<br>2.the per-region detection rate of 18F-fluciclovine versus 18F-DCFPyL;<br>3.the side-effects of 18F-DCFPyL;<br>4.the inter-observer agreement. <br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 2. the detection rates on a patient-based analysis of 18F-DCFPyL and 18F-fluciclovine PET/CT stratified by PSA level (0.2-0.5; 0.51-1.0; 1.01-2.0 ng/mL);<br>3. the per-region detection rate of 18F-fluciclovine versus 18F-DCFPyL;<br>4. the side-effects of 18F-DCFPyL;<br>5. the inter-observer agreement. <br>;Timepoint(s) of evaluation of this end point: Please see above.