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

NCT03911310 | Completed Phase 3

• 1 other identifier: AGO/2018/003
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

prostate cancer; biochemical recurrence; 18F-PSMA PET imaging

Outcome Measures

Primary Outcomes (1)

• Evaluation of the non-inferiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the number of positive PET scans. Hereby, a positive PET scan is defined as a scan showing at least one suspected lesion.

  The non-inferiority of \[18F\]PSMA-11 will be investigated based on a Tango's score two-sided 95% confidence interval (CI) for a difference of proportions of positive scans of \[18F\]PSMA-11 compared to \[68Ga\]PSMA-11 with matched pairs. Non-inferiority will be concluded if the lower limit of this CI is larger than 0.10 (non-inferiority limit).

  0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11

Secondary Outcomes (7)

• Evaluation of the superiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the number of positive PET scans. Hereby, a positive PET scan is defined as a scan showing at least one suspected lesion.

  0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11

• Evaluation of the superiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the total number of suspected prostate cancer lesions in corresponding ([68Ga]PSMA-11 vs [18F]PSMA-11) scans.

  0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11

• Evaluation of the superiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the scoring of corresponding ([68Ga]PSMA-11 vs [18F]PSMA-11) suspected lesions.

  0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11

• Descriptive evaluation of [18F]PSMA-11 compared to [68Ga]PSMA

  0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11

• Evaluation of the diagnostic specificity of [18F]PSMA-11 compared to [68Ga]PSMA-11

  0 to 180 days post [18F]PSMA-11 and [68Ga]PSMA-11 administration

Study Arms (2)

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

EXPERIMENTAL

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.

Diagnostic Test: [18F]PSMA-11; Diagnostic Test: [68Ga]PSMA-11

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

ACTIVE COMPARATOR

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

Diagnostic Test: [18F]PSMA-11; Diagnostic Test: [68Ga]PSMA-11

Interventions

[18F]PSMA-11 DIAGNOSTIC_TEST

\[18F\]PSMA-11 PET/CT

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

[68Ga]PSMA-11 DIAGNOSTIC_TEST

\[68Ga\]PSMA-11 PET/CT

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: male with prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with prostate cancer, either in the setting of diagnosis of biochemical recurrence after previous treatment, or at primary diagnosis and staging.

You may not qualify if:

• Age \< 18 years
• Physically or mentally unfit to perform the sequential procedures
• Refusal of patient to be informed about accidental findings on scans
• History of anaphylactic shock after administration of Visipaque CT contrast
• Serum creatinine concentration \> 2.0 mg/dl and/or estimated glomerular filtration rate \< 60 ml/min.

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, East Flanders, 9000, Belgium

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Piet Ost, Prof.

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 11, 2019
• Study Start: April 1, 2019
• Primary Completion: March 20, 2020
• Study Completion: September 20, 2020
• Last Updated: January 22, 2021

Record last verified: 2021-01

Locations

BE (1)