Clinical trial NCT06122584: Diagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients With Newly-Diagnosed Prostate Cancer
Official title: Prospective, Multi-Center Study to Assess the Diagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients With Newly-Diagnosed High-Risk or Very-High-Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Prostate Cancer
Lead sponsor: ABX advanced biochemical compounds GmbH
Sponsor class: INDUSTRY
First posted: 2023-11-08
Enrollment: 380
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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


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.

Primary outcomes:
measure: Sensitivity and specificity of [18F]PSMA-1007 PET/CT for the detection of pelvic nodal disease (N1) compared to histology as the standard of reference
timeFrame: 6 to 8 weeks post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU de Nancy
city: Barcelona
country: Spain
facility: Hospital Del Mar
city: Valencia
country: Spain
facility: Hospital Vithas Valencia 9 de Octubre
Study officials:
References: