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Completed

NCT Number: NCT03573011

PSMA PET/CT for Prostate Cancer

Prostate cancer is the most frequently occurring male cancer in Belgium. Patients who have been treated for prostate cancer, i.e. by surgery and/or radiotherapy, in a substantial degree suffer from a tumor recurrence, often diagnosed by an increase in serum tumor marker Prostate Specific Antigen (PSA) within the first few years. In these patients with evidence of a tumor recurrence after primary treatment, it is important to most exactly define the location(s) of tumor, to guide appropriate therapy by surgery, radiotherapy and/or hormonotherapy. 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.

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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 2

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
  • Patients with heart failure if ejection fraction < 45% (phase 2 trial)
  • History of anaphylactic shock after administration of Visipaque CT contrast (phase 2 trial)

Treatment and study plan

[18F]PSMA-11

Diagnostic Test

18F-PET imaging

Primary outcomes

  1. Evaluation of effective targeting of prostate cancer and eventual metastases

    Time frame: 0 to 3.5 hours post radiotracer injection

    Two PET/CT scans with [18F]PSMA-11 will be acquired to evaluate the effectiveness of targeting prostate cancer and eventual metastases

  2. Determination of the optimal scan protocol: define optimal time of scanning

    Time frame: 0 to 3.5 hours post radiotracer injection

    Based on the quality of the images and feasibility of tumor targetting (4 point '0-3' scoring scale - higher score represents a higher intensity lesion), the optimal time (60 min or 180 min post radiotracer injection) will be defined

  3. Determination of the optimal scan protocol: define optimal scan duration

    Time frame: 0 to 3.5 hours post radiotracer injection

    Based on the quality of the images and feasibility of tumor targetting (4 point '0-3' scoring scale, higher score represents a higher intensity lesion), the optimal scan duration (1.5 minutes/bed position or 3.0 minutes/bed position) will be defined

  4. Determination of the optimal scan protocol: define optimal dose

    Time frame: 0 to 3.5 hours post radiotracer injection

    Based on the overall image quality (7 point '1-7' scoring scale for image blurriness, higher score represents a higher quality image), the optimal dose of [18F]PSMA-11 (2.0 or 4.0 MBq/kg) will be defined

  5. Determination of the optimal scan protocol: evaluation of the added value of furosemide (to improve diuresis), as part of the standard scanprotocol

    Time frame: 0 to 1.5 hours post radiotracer injection

    Based on the degree that the radiotracer uptake in the bladder and in the ureters is disruptive for the interpretation of the scan (visual interpretation by nuclearist using a 7 point '1-7' scoring scale, higher score equals a more pronounced disturbance), the added value of furosemide, as part of the standard scanprotocol, will be defined

Secondary outcomes

  1. Evaluation of the inter-observer difference for interpretation of [18F]PSMA-11 scans

    Time frame: 0 - 60 days post [18F]PSMA-11 administration

    The inter-observer difference for analysing the [18F]PSMA-11 PET images will be investigated between at least two nuclear physicians. Results will be expressed as a cohen's kappa

  2. Evaluation of the diagnostic specificity of [18F]PSMA-11

    Time frame: 0 - 60 days post [18F]PSMA-11 administration

    Following the [18F]PSMA PET/CT scans in the phase 2 trial, the treating physician will continue the follow-up and treatment of the patient. Hereby, depending of the selected conventional treatment or procedure, the following data will be also collected (if available within 60 days following the day of the [18F]PSMA scan) to investigate the diagnostic specificity of [18F]PSMA-11:

    • In case the treating physician opts to perform a radical prostatectomy or lymphadenectomy or to take a biopt, the anatomopathological diagnosis (PSMA expression in tissue) will be used as an endpoint for correlation with the results of the [18F]PSMA scan.
    • In case the treating physician opts for radiotherapy or hormone therapy, the (change in) PSA levels will be used as an endpoint for correlation with the results of the [18F]PSMA scan.
    • In case the treating physician opts to acquire an additional MRI, suspicious lesions on the MRI will be also compared with those observed on the [18F]PSMA PET/CT scan.

  3. Evaluation of the impact of the [18F]PSMA-11 scan on the choice of therapy

    Time frame: Pre [18F]PSMA-11 PET management plan: between the date the patient signed the informed consent form and the date of the [18F]PSMA-11 scan. Post [18F]PSMA-11 PET management plan: 0 - 60 days post [18F]PSMA-11 administration

    The treating physician must fill in a questionnaire concerning the patients 'pre [18F]PSMA-11 PET' management plan. After the scan, the physician must fill in a second part of the questionnaire concerning how the [18F]PSMA-11 scan would influence the patient's treatment plan.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

PSMA-PET/CT for Prostate Cancer - Phase 2 Trial

Acronym: NGP2

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jun 28, 2018
Registry last updated
May 6, 2019

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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