Demonstrating or ruling out metastasis of prostate cancer is necessary to draw up a good treatment plan and helps to estimate the course of the disease. The aim of this study is to find out whether use of the radioactive contrast agent 18F-FAPI-74…
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The added diagnostic value of FAPI PET/CT, relative to PSMA PET/CT, in staging
of newly diagnosed PCa.
Secondary outcome
Secondary endpoints: the diagnostic accuracy of FAPI PET/CT by correlating FAPI
PET/CT findings to clinical follow-up and histopathological and/or laboratory
findings.
Background summary
One in seven men will be affected by prostate cancer. When diagnosed with
prostate cancer, in some cases it is important to assess the extent of the
disease. A PSMA PET/CT scan is used for this. A PSMA PET/CT scan works by
administering a radioactive contrast agent. It enters the bloodstream through a
drip and spreads throughout the body. The radioactive contrast agent emits
radiation for a short time. This radiation can be converted into images during
the scan. On these images, cancerous tissue lights up many times more than
healthy tissue. The accuracy of this current technique to detect possible
metastases of prostate cancer is good, but in some cases not optimal.
To improve accuracy, we are researching a new radioactive contrast agent,
18F-FAPI-74. 18F-FAPI-74 consists of very small radioactive particles that can
be taken up by cancer tissue. This contrast agent differs from the contrast
agents currently used in that it targets the cells surrounding the prostate
cancer cells and not the prostate cancer cells themselves. 18F-FAPI-74 has
already been studied in various cancers (breast cancer, skin cancer, colon
cancer, lung cancer, etc.) with good results. The accuracy of 18F-FAPI-74 in
these cancers is as good and sometimes even better than current radioactive
contrast agents. These studies have shown that 18F-FAPI-74 can be used safely
and does not cause any complaints. However, to date, few studies have
investigated the use of 18F-FAPI-74 in men with newly diagnosed prostate
cancer. In this study we therefore want to investigate whether 18F-FAPI-74 is
better than current techniques in detecting prostate cancer metastases in men
with recently diagnosed prostate cancer.
Study objective
Demonstrating or ruling out metastasis of prostate cancer is necessary to draw
up a good treatment plan and helps to estimate the course of the disease. The
aim of this study is to find out whether use of the radioactive contrast agent
18F-FAPI-74 can improve the accuracy of detecting prostate cancer metastases
compared to a standard contrast agent currently used (18F-PSMA-JK7).
Study design
This is an investigator initiated, multicenter, prospective, non-randomized
diagnostic pilot study and follows a prospective cross-sectional design.
Study burden and risks
Participation in this study has no significant risks and will not induce a
delay in diagnosis or treatment since outcomes of FAPI PET/CT scans will not
guide treatment decisions. The FAPI PET/CT scan involves a total procedure
duration of 1.5 hour and an estimated radiation dose of 6 mSv per procedure (3
mSv for an average administered dosage of 200 MBq 18F-FAPI-74, and 3 mSv for
the associated low dose CT scan). This radiation dose of 6 mSv is well within
the range of normal diagnostic procedures and does not induce a significant
risk in the selected population with PCa. In addition, the 18F-FAPI-74
radiopharmaceutical is thus far not associated with side effects after
injection. Finally, it may be anticipated that the value of an improved and
more sensitive image modality could have an improved impact on the cancer
treatment.
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
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:
- Male, aged >= 18 years;
- WHO performance status 0, 1 or 2;
- Written informed consent;
- Biopsy-proven newly diagnosed PCa;
- International Society of Urological Pathology (ISUP) grade group (GG) >= 3
and/or PSA >= 20 ng/ml and/or >=cT3a.
If all of the criteria above are met, a subject must also meet all of the
following subgroup specific criteria:
Group 1 (n=15):
- PSMA PET/CT with PSMA-avid primary tumor with PSMA-avid loco-regional and/or
distant metastases.
Group 2 (n=15):
- PSMA PET/CT with PSMA-avid primary tumor with no PSMA-avid loco-regional or
distant metastases;
- Increased risk of nodal metastases according to the Briganti 2019 nomogram
(Briganti >=40%)
- Scheduled for (laparoscopic) prostatectomy including ePLND.
Exclusion criteria
- Known second malignant disease that may complicate image interpretation.
- Inability to cooperate with the scan process: inability to lie relatively
still and in supine for 30-60 minutes or patient body habitus above scanner
dimensions.
Design
Recruitment
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 |
|---|---|
| CCMO | NL83218.041.23 |