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.

Phase 3

Recruiting

Conditions: 10036958
malignancy of the prostate
Prostate cancer

Registration Number: NL-OMON50844

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

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.

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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The per patient detection rate (proportion of patients with PET-positive<br /><br>findings) of 18F-fluciclovine versus 18F-DCFPyL PET/low-dose CT for the<br /><br>identification of tumor/ metastatic localization(s). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. the detection rates on a per patient-based analysis of 18F-DCFPyL and<br /><br>18F-fluciclovine PET/low-dose CT, stratified by PSA level (0.2-0.5; 0.51-1.0;<br /><br>1.01-2.0 ng/mL);<br /><br>2. the per-region detection rate of 18F-fluciclovine versus 18F-DCFPyL;<br /><br>3. the side-effects of 18F-DCFPyL;<br /><br>4. the inter-observer agreement. </p><br>