[18F]PSMA-11 PET/CT Phase 3 Clinical Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-09-20

Brief Summary

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Prostate cancer (PCa) is the most frequently occurring male cancer in Belgium. After treatment with surgery and/or radiotherapy, almost half of the patients suffer from a tumor recurrence, often diagnosed by an increase in serum tumor marker Prostate Specific Antigen (PSA) within the first few years after primary treatment. However, for salvage therapy to be successful, precise localization of metastases is necessary to determine the most appropriate treatment. In so-called oligo-metastatic disease targeted therapy may still be curative and prevent the disease from spreading to distant locations. Therefore it is of paramount importance to have an accurate tool of medical imaging to localize all possible locations to be treated.

Recently, prostate specific membrane antigen (PSMA) has gained interest for PCa-specific imaging. Due to overexpression of PSMA in both primary and metastatic PCa, radiotracers targeting this protein have shown an increased selectivity and sensitivity compared to conventional imaging. The main objective of this phase 3 trial is to determine the position of \[18F\]PSMA-11 PET/CT within the field of available radiotracers for diagnosis of prostate cancer. For this, the diagnostic performances of \[18F\]PSMA-11 will be compared to those of the current state-of-the-art radiotracer \[68Ga\]PSMA-11.

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Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The trial encompasses a double-blind randomized cross-over design whereby each patient will be subjected to a \[18F\]PSMA-11 scan and a \[68Ga\]PSMA-11 scan, with an interscan period of four days to maximum three weeks. Half of the patients will be first scanned with \[18F\]PSMA-11 and subsequently (maximum three weeks later) with \[68Ga\]PSMA-11. The scan order in the remaining group of patients will be reversed. Randomization of patients to one of these groups will be performed using a block randomization design with block sizes of six.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

The assigned scan order will be blind to the recruiting physicians and the nuclear medicine physicians interpreting the images.

Next to the clinical trial coordinators, also the staff members responsible for the preparation of the individual \[18F\]PSMA-11 and \[68Ga\]PSMA-11 dose and the IV injection of this dose are aware of the scan order which means that they are NOT blinded. However, these staff members do not carry out any further study specific handlings.

Study Groups

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PET/CT 1: [18F]PSMA-11, PET/CT 2: [68Ga]PSMA-11

Patients in this arm will first receive the experimental radiotracer \[18F\]PSMA-11 PET/CT followed by the \[68Ga\]PSMA-11 PET/CT after at least 4 days and maximum 3 weeks.

Group Type EXPERIMENTAL