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Trial Title:
Diagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients With Newly-Diagnosed Prostate Cancer
NCT ID:
NCT06122584
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
[18F]PSMA-1007
Description:
Diagnostic radiopharmaceutical for PET scan
Arm group label:
[18F]PSMA-1007
Summary:
This study assess the Diagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients
with Newly-Diagnosed High-Risk or Very-High-Risk Prostate Cancer
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. The patient (male) is aged 18 years or above.
2. The patient is able to understand the information presented to him concerning the
nature, scope, and consequences of the trial as set out in the information provided
to the patient AND has provided written informed consent to participate.
3. The patient has newly diagnosed, biopsy-proven, clinically localized prostate
adenocarcinoma, and curative prostatectomy with extended pelvic lymph node
dissection is his preferred course of treatment.
4. The patient has at least high-risk disease as defined by the NCCN guidelines
(version 1.2023). That is, the presence of any one or more of the following:
- Overall ISUP grade group 4 or 5,
- Clinical category T3a or greater,
- Serum PSA level greater than 20 ng/ml.
5. The patient has undergone conventional imaging (CT or MRI, and bone scan if
clinically indicated) to detect the presence of pelvic nodal involvement and bone or
visceral metastases within 60 days of the planned PET-CT procedure.
Exclusion Criteria:
1. Patients for whom radical prostatectomy is not clinically appropriate or the patient
is otherwise unlikely to undergo radical prostatectomy with extensive pelvic lymph
node dissection.
2. The patient has received any therapy - be it radiation, surgical or drug therapy -
for his prostate cancer.
3. The patient has any contraindication(s) for and/or known hypersensitivity to any
constituent(s) of [18F]PSMA-1007.
4. The patient is not able to have PET-CT scans (for example, because of weight,
claustrophobia, or inability to lie still for the duration of the scan).
5. The patient is closely affiliated to the investigation site; e.g. is a first-degree
relative of the investigator.
6. At the time of screening, the patient is receiving any other investigational
agent(s), or he has received any such agent(s) within the previous 30 days, or he is
scheduled to receive any such agent(s) in the period up to the planned date for the
last study visit.
7. The patient has previously been enrolled in this trial.
8. The patient has previously undergone PET imaging with any PSMA-avid product.
9. The patient has histological evidence of small-cell carcinoma of the prostate.
10. The patient is clinically unstable or requires emergency treatment.
11. The patient has any mental condition rendering him incapable of understanding the
nature, scope, and consequences of the trial as set out in the information given to
the patient.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CHRU de Nancy
Address:
City:
Nancy
Country:
France
Status:
Recruiting
Facility:
Name:
Hospital Del Mar
Address:
City:
Barcelona
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Vithas Valencia 9 de Octubre
Address:
City:
Valencia
Country:
Spain
Status:
Recruiting
Start date:
June 13, 2024
Completion date:
April 2025
Lead sponsor:
Agency:
ABX advanced biochemical compounds GmbH
Agency class:
Industry
Source:
ABX advanced biochemical compounds GmbH
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06122584
