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Completed

NCT Number: NCT03911310

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

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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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Ghent University Hospital

Ghent, East Flanders, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

[18F]PSMA-11

Diagnostic Test

[18F]PSMA-11 PET/CT

[68Ga]PSMA-11

Diagnostic Test

[68Ga]PSMA-11 PET/CT

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.

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

    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).

Secondary outcomes

  1. 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.

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

    Superiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the number of positive PET scans will be statistically assessed by applying a McNemar's test on the proportions of positive PET scans in each group. Hereby, superiority is defined as a difference of minimum 10% in the proportions of positive PET scans ([18F]PSMA-11 > [68Ga]PSMA-11).

  2. 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.

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

    The McNemar-Bowker test of symmetry of k X k contingency tables will be applied to investigate differences between [18F]PSMA-11 and [68Ga]PSMA-11 scans. Hereby, the superiority is defined as a difference of minimum 10% ([18F]PSMA-11 > [68Ga]PSMA-11).

  3. 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.

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

    The McNemar-Bowker test of symmetry of k X k contingency tables will be applied to investigate differences between [18F]PSMA-11 and [68Ga]PSMA-11 scans. Hereby, the superiority is defined as a difference of minimum 10% ([18F]PSMA-11 > [68Ga]PSMA-11).

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

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

    This endpoint will be examined in the total group of patients, as well as in a subgroup of patients with a specific disease stage including primary diagnosis, castrate sensitive biochemical recurrence, and castrate resistant biochemical recurrence. Additionally, within these subgroups, a further subdivision can be made on the basis of a specific location of the suspected lesions, PSA values, PSA doubling times and metastatic disease burden).

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

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

    This endpoint will be evaluated in a descriptive way, more specifically by a description of the number of positive scans (and/or positive lesions) that can be confirmed via an anatomopathological diagnosis, changes in PSA concentration or via MRI, and by comparison of these numbers between [18F]PSMA-11 and [68Ga]PSMA-11.

  6. Evaluation of the safety of [18F]PSMA-11 administration: CTCAE 4.0 criteria

    Time frame: 0 to 24 h post [18F]PSMA-11 and [68Ga]PSMA-11 administration

    Adverse events will be reported and scored (CTCAE 4.0 criteria) between the first dose administration of trial medication and the last trial related activity. From the time of radiotracer injection till completion of the PET/CT scan (for both [18F]PSMA-11 and [68Ga]PSMA-11), the site staff will visually observe and actively ask the patient whether or not he has observed any adverse effects. Although [18F]PSMA-11 is totally eliminated from the body within 9 hours post injection (= 10 x half-life of 47 ± 5 minutes), AE's occurring up to 24h after the second PET/CT scan will also be handled as such if spontaneously reported by the patient to the investigator.

  7. Assessment of the interobserver variability with regard to the evaluation of the [18F]PSMA-11 and [68Ga]PSMA-11 PET scans

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

    This endpoint will be evaluated by determining a Cohen's kappa value

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Acronym: NGP3

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 11, 2019
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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