To head-to-head compare the per patient detection rate of 18F-Fluciclovine PET/CT versus 18F-DCFPyL PET/CT in patients with BCR of disease after radical prostatectomy.
ID
Source
Brief title
Condition
- Prostatic disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The *per patient detection rate* (proportion of patients with PET-positive
findings) of 18F-fluciclovine versus 18F-DCFPyL PET/low-dose CT for the
identification of tumor/ metastatic localization(s).
Secondary outcome
1. the detection rates on a *per patient-based* analysis of 18F-DCFPyL and
18F-fluciclovine PET/low-dose CT, stratified by PSA level (0.2-0.5; 0.51-1.0;
1.01-2.0 ng/mL);
2. the per-region detection rate of 18F-fluciclovine versus 18F-DCFPyL;
3. the side-effects of 18F-DCFPyL;
4. the inter-observer agreement.
Background summary
Prostate cancer (PCa) has the highest incidence of all cancers among men of 50
years and older in the Western world. The most common treatments for men with
localized disease are radical prostatectomy and local radiation therapy. After
radical prostatectomy or radiation therapy, between 27% and 53% of patients
develop biochemical recurrence (BCR) of disease on follow-up. Accurate staging
of BCR is important in order to determine prognosis, and select and plan
potentially curative salvage treatment. Conventional imaging techniques, such
as bone scintigraphy, and computer tomography (CT), have only limited
sensitivity and specificity in the detection of (early) recurrent disease or
metastases, and are outperformed by modern imaging modalities (e.g., positron
emission tomography/ computed tomography (PET/CT). As of today,
18F-fluciclovine PET/CT (Axumin®) is one of the two registered PET tracers to
be used in patients with BCR, besides choline. 18F-fluciclovine PET/CT has
slightly better accuracy for the detection of disease recurrence compared to
11C-choline PET/CT (38% versus 32%).
Modern imaging techniques are now being applied and investigated, specifically
18F-PSMA DCFPyL (PSMA PET/CT). 18F-DCFPyL is frequently used for the primary
staging of patients with newly diagnosed PCa and for secondary staging purposes
in patients with recurrent disease. Current literature suggests that 18F-DCFPyL
PET/CT has promising accuracy for localization of disease on BCR, though
18F-DCFPyL PET/CT has not been directly compared to 18F-fluciclovine PET/CT.
Study objective
To head-to-head compare the per patient detection rate of 18F-Fluciclovine
PET/CT versus 18F-DCFPyL PET/CT in patients with BCR of disease after radical
prostatectomy.
Study design
A prospective, single-center, open-label study. Total population of patients
for this study will be 50.
Intervention
All participants of this study will undergo an 18F-fluciclovine PET/low-dose CT
and an 18F-DCFPyL PET/low-dose CT. Tracers need to be administered at minimal
24 hours and maximal 15 days from each other.
Study burden and risks
1. The study will require time and effort from participating patients.
2. One additional site visit to the nuclear department facility is necessary,
to perform both scans.
3. Patients will undergo one additional PET/low-dose CT scan, resulting in an
extra radiation dose of approximately 8mSv. The burden of such a low additional
radiological exposure dose is probably negligible with respect to cancer
genesis (estimated risk 0.0267% in a 65-year-old male).
4. No questionnaires will be delivered.
5. No physical examinations or other tests will be performed.
6. Adverse events observed, mentioned upon open questioning, or spontaneously
reported will be recorded during the first 24 hours following each injection
for the investigational imaging tracer.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2021-001123-40-NL |
| CCMO | NL77045.029.21 |