To evaluate diagnostic accuracy of PSMA-PET/CT and FACBC-PET/CT in detection of lymph node metastases in initial staging of intermediate- to high-risk PCa.
ID
Source
Brief title
Condition
- Renal and urinary tract neoplasms malignant and unspecified
- Renal and urinary tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter is patient- and lesion-based diagnostic accuracy of
18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT in detection of lymph node
metastases. Secondary study parameters are (a) diagnostic performance of
18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT in detection of distant
metastases, (b) diagnostic performance of 18F-PSMA-1007 PET/CT and anti-3-[18F]
FACBC PET/CT in staging of the primary tumor in the prostate specimen, (c)
detection rate of 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT as a
function of PSA level, nomogram risk and size of suspected lymph nodes, (d)
change of management induced by 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC
PET/CT and (e) cost-associated with 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC
PET/CT as diagnostic modality additional to the regular diagnostic work-up
versus pelvic lymph node dissection.
Secondary outcome
a. Detection rate of 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT for the
detection of distant (bone) metastases.
b. Diagnostic accuracy of 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT in
staging of the primary tumor in the radical prostatectomy specimen.
c. Diagnostic accuracy of 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT
for different risk groups (according to the d*Amico classification - see
chapter 5.1.3), nomogram risk scores, and the size of malignant lymph nodes.
d. Diagnostic performance of 18F-PSMA-1007 PET/CT versus anti-3-[18F] FACBC
PET/CT versus conventional imaging (MRI of the prostate) in detection of local
tumor site and metastases.
e. Change of management induced by 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC
PET/CT findings specifically.
f. Cost-effectiveness of 18F-PSMA-1007 PET/CT versus anti-3-[18F] FACBC PET/CT
for the detection of (regional) LNMs.
Background summary
Prostate cancer (PCa) is the most common malignancy amongst men in Western
countries. In order to select the most suitable treatment for patients
diagnosed with PCa, it is important to stage accurately. Lymph node metastasis
have a negative effect on the prognosis, and furthermore, they can be
associated with systemic metastasis. This means it is key to accurately
diagnose the presence of these lymph node metastasis. Diagnostic accuracy of
conventional imaging modalities (e.g. bone scintigraphy, CT, MRI) for the
detection of (lymph node) metastases however, proved to be limited.
To improve detection of metastases, it might be preferable to use other
diagnostic imaging techniques.
Both 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT are currently mostly
used to detect recurrence in treated PCa, while the diagnostic value in
detecting lymph node metastasis in primary prostate cancer is not yet clear.
The present study therefore aims to determine the diagnostic accuracy of
18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT in initial staging of
intermediate- to high-risk PCa, by comparing both techniques to each other and
to pelvic lymph node dissection (PLND).
Study objective
To evaluate diagnostic accuracy of PSMA-PET/CT and FACBC-PET/CT in detection of
lymph node metastases in initial staging of intermediate- to high-risk PCa.
Study design
Prospective cohort study.
Intervention
PSMA-PET/CT and FACBC-PET/CT, prior to lymph node dissection (PLND)
Study burden and risks
The included patients will undergo 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC
PET/CT prior to pelvic lymph node dissection. Conform the standard of care,
patient would only undergo one PET/CT. This means there is one extra
study-related intervention, leading to extra radiation exposure. Next to that,
patients are required to read the patient information form, which will take
approximately 15 minutes. The results of 18F-PSMA-1007 PET/CT and anti-3-[18F]
FACBC PET/CT in the diagnostic process of prostate cancer will presumably give
us more information about the best way to detect lymph node and distant
metastases in an early stage. Ascertaining presence of metastatic disease will
be of added value for individual patients in this study to guide treatment, and
in the future possibly for all PCa patients
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
1. Biopsy proven adenocarcinoma of the prostate;
2. Indication for (super)extended PLND (with or without (robot-assisted)
laparoscopic prostatectomy), in intermediate and high risk patients ( d*Ámico
score) with an MSKCC >5% lymph node prediction;
3. Mentally competent and understanding of benefits and potential burden of the
study;
4. Written informed consent;
5. Age >=18 years.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
1. History of prior diagnosed or treated PCa.
2. Known concomitant malignancies (except Basal Cell Carcinoma of the skin).
3. Unwillingness or inability to undergo 18F-PSMA-1007 PET/CT and anti-3-[18F]
FACBC PET/CT, in combination with PLND.
4. Metastasis beyond pelvic region and/or bone metastasis. Patients with bone
metastasis will not get a PLND, but will be included in the study for further
follow-up.
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 | EUCTR2019-004045-33-NL |
| CCMO | NL70759.100.19 |