The primary study objective is to compare: - Per-patient detection rate of 18F-DCFPyL PET/CT versus that of 18F-FCH PET/CT. The secondary objectives are to assess: - Impact on patient treatment/management. - Per-region detection rate of 18F-DCFPyL…
ID
Source
Brief title
Condition
- Other condition
- Endocrine neoplasms malignant and unspecified
Synonym
Health condition
Biochemical recurrent prostate cancer
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint:
Per-patient detection rate of 18F-DCFPyL PET/CT and 18F-FCH PET/CT for
recurrence (either local, regional or distant), based on the
independent central reading. The detection rate is defined as the ratio between
the number of patients defined as positive at patient level by at
least 2 independent readers, and the total number of assessed patients.
Secondary outcome
Secondary endpoints:
- Impact on patient treatment/management.
- Per-region detection rate of 18F-DCFPyL PET/CT versus that of 18F-FCH PET/CT.
- Sensitivity and specificity of 18F-DCFPyL PET/CT versus that of 18F-FCH
PET/CT on a per-patient and per-region basis, using composite SOR.
- Concordance rate between 18F-DCFPyL PET/CT and 18F-FCH PET/CT for regions
using composite SOR.
- Safety of 18F-DCFPyL versus that of 18F-FCH
Ten regions will be assessed:
- prostate bed (T),
- pelvic lymph nodes (N),
- retroperitoneal lymph nodes, supradiaphragmatic lymph nodes (M1a),
- bone (M1b), five subcategories will be assessed: *spine*, *ribs, sternum and
scapula*, *iliac and sacrum*, *femurs and humerus*, *others*,
- other organ (M1c).
Background summary
Prostate cancer (PCa) is recognized as one of the principal medical problem the
male population is facing. Most men dying of prostate cancer succumb to
metastatic and/or recurrent disease. Moreover, rising PSA after initial
definitive therapy (known as biochemical recurrence (BCR) of PCa) may occur in
20-30% of prostate cancer patients within 5 years, before a more definitive
diagnosis of metastatic disease can be established by conventional imaging
modalities. The key question in case of BCR remains whether the PSA rise is
reflective of locally confined recurrence or is caused by distant metastatic
disease. Correct identification is essential for further treatment planning
because, in local recurrence or loco regional lymph node metastasis,
potentially curative local treatment may still be possible, whereas in distant
metastasis, watchful waiting or eventually (palliative) systematic treatment
should be considered.
While identification of biochemical recurrence (BCR) post therapy can be
achieved with the prostate specific antigen (PSA) test, localization of
recurrence can be challenging with conventional imaging modalities, like MRI or
CT scans, that can*t match the sensitivity of this blood test.
PET-CT has overcome many limitations of conventional imaging, resulting in more
accurate assessment of patients with BCR. With a new class of positron emission
tomography (PET) radiopharmaceuticals targeting the prostate specific membrane
antigen (PSMA), it has become feasible to detect recurrent or metastatic
prostate cancer that is otherwise occult on conventional imaging modalities.
PSMA is a transmembrane glycoprotein expressed by virtually all prostate
cancers, and its expression is further increased in metastatic and
hormone-refractory prostate carcinomas.
Various radiolabeled anti-PSMA monoclonal antibodies have been used to detect
prostate cancer nodal metastasis and recurrence. 18F-DCFPyL is a radiolabeled
small molecule that binds to the extracellular domain of prostate-specific
membrane antigen (PSMA) with high affinity.
In this study, we aim to determine the detection rate of 18F-DCFPyL PET/CT in
patients with first biochemical recurrence and assess the clinical impact of
18F-DCFPyL PET/CT in patient management and to evaluate the safety of this
radiopharmaceutical for clinical use.
Study objective
The primary study objective is to compare:
- Per-patient detection rate of 18F-DCFPyL PET/CT versus that of 18F-FCH
PET/CT.
The secondary objectives are to assess:
- Impact on patient treatment/management.
- Per-region detection rate of 18F-DCFPyL PET/CT versus that of 18F-FCH PET/CT.
- Sensitivity and specificity of 18F-DCFPyL PET/CT versus that of 18F-FCH
PET/CT on a per-patient and per-region basis, using a composite SOR.
- Concordance rate between 18F-DCFPyL PET/CT and 18F-FCH PET/CT for regions
using a composite SOR.
- Safety of 18F-DCFPyL versus that of 18F-FCH
Study design
This is a prospective, open label, cross-over, comparative study. The study
population is diagnosed in the past with histopathologically confirmed prostate
adenocarcinoma, for which curative therapy is received. The results of the PSA
test suspects that the patient has biochemical recurrence of prostate cancer,
defined by:
- PSA * 0.2 ng/mL confirmed by a subsequent PSA value of *0.2 ng/mL, if the
patient has previously been treated by radical prostatectomy +/- eLND,
- Rise of PSA > 2 ng/mL above the nadir after therapy, regardless of the serum
concentration of the nadir, if the patient has previously been treated by
curative radiation therapy (EBRT or brachytherapy).
Patients are randomized to determine the order of the 2 radiodiagnostic agents
to be used.
The evaluation of the PET / CT scans will be performed blinded by a central
reading center.
Intervention
In this study, 2 radiodiagnostic tracers, intravenously administered, will be
used:
- 18F-DCFPyl
- 18F-Fluoromethylcholine.
Study burden and risks
Biochemical recurrence (BCR) of prostate cancer occurs in 20-30% of the patient
before a more definitive diagnosis of metastatic disease can be established by
conventional imaging modalities. With a PET-CT, using the radiopharmaceutical
tracer [18F]-DCFPyL it is thought to early detect recurrent and/or metastatic
prostate cancer in patients with BCR
Two PET/CT scans will be made during the study, one with the
radiopharmaceutical study product [18F]-DCFPyL and one with the
radiopharmaceutical product [18F]-Fluoromethylcholine.
The general risks related to any PET scan are especially:
- Irradiation risks which are very low. Indeed, the main risk related to
irradiation concerns the kidneys which are the critical organs as they will
participate in the elimination of the diagnostic product from the body.
Therefore, the maximum dose to be injected was chosen so that it will be lower
than the irradiation received during an x-ray of the kidneys.
- Allergic reactions that may occur but remain extremely low.
The risk related to the PET scan with [18F]-DCFPyL:
- [18F]-DCFPyL has been used in the US and in the Netherlands in many clinical
studies, the product appeared to be well tolerated and no severe side effects
were reported in those studies.
- Based on those studies, the patient may experience fatigue, dysgeusia or
headache.
The risk related to the PET scan with [18F]-Fluoromethylcholine:
- To date, no side effects have been described.
With a PET scan X-ray radiation and radioactive substances are used. The total
radiation burden in this study is 17.2 mSv. In comparison: the background
radiation in the Netherlands is ~2.5 mSv, per year.
The radiation used during the study may cause damage to the patient's health.
Blood draw:
The risks involved in drawing blood from a vein may include, but are not
limited to, momentary discomfort and/or pain at the site of the blood draw,
possible bruising, redness, and swelling around the site, bleeding at the site,
feeling of lightheadedness when the blood is drawn, and rarely, an infection at
the site of the blood draw.
The following procedures will be performed during the study:
- undergo physical examination (1x)
- measurement of vital signs (6x)
rue Marie Curie 3
Saint-Beauzire 63360
FR
rue Marie Curie 3
Saint-Beauzire 63360
FR
Listed location countries
Age
Inclusion criteria
1. Male.
2. Age * 18 years.
3. Histopathological proven prostate adenocarcinoma per original diagnosis.
4. First suspected recurrence of prostate cancer based on rising
prostate-specific antigen (PSA) after initial curative therapy with radical
prostatectomy of PSA * 0.2 ng/mL confirmed by a subsequent PSA value of *0.2
ng/mL or with radiation therapy (external beam or brachytherapy) of PSA > 2
ng/mL above the nadir after therapy regardless of the serum concentration of
the nadir.
5. Able and willing to provide informed consent and comply with protocol
requirements
6. Patient who can undergo all study procedures per Investigator*s point of
view
7. Patient with social insurance cover.
Exclusion criteria
1. ECOG > 2
2. History of previous salvage therapies (including salvage radiotherapy or
salvage lymph node dissection)
3. History of adjuvant radiotherapy
4. History of cryotherapy, high-intensity focused ultrasound (HIFU)
5. Other active malignant tumour
6. Treatment with Androgen Deprivation Therapy (ADT) in the past 30 days or
ongoing
7. Treatment with colchicine in the past 8 days or ongoing
8. Treatment with hematopoietic colony stimulating factors (CSF) in the past 5
days or ongoing
9. Unable to lie supine for imaging
10. Known allergy to investigational or reference products or to any excipients
11. Unable to provide written consent (linguistic or psychological inability)
12. Participation in another clinical study within one month prior to inclusion
13. Uncooperative, in the Investigator's opinion.
14. Subjects deprived of their freedom by administrative or legal decision or
who are under guardianship
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 | EUCTR2020-000121-37-NL |
| CCMO | NL72802.029.20 |