PSMA PET/CT for Prostate Cancer

Prostate Cancer Clinical Trial

— NGP2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03573011
• Other study ID #: AGO/2017/006 phase 2 trial
• Secondary ID: 2017-003461-96
• Status: Completed
• Phase: Phase 2
• Start date: June 15, 2018
• Est. completion date: February 18, 2019

Study information

• Verified date: January 2019
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: February 18, 2019
• Est. primary completion date: December 20, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• [18F]PSMA-11
18F-PET imaging

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent	East Flanders

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of effective targeting of prostate cancer and eventual metastases	Two PET/CT scans with [18F]PSMA-11 will be acquired to evaluate the effectiveness of targeting prostate cancer and eventual metastases	0 to 3.5 hours post radiotracer injection
Primary	Determination of the optimal scan protocol: define optimal time of scanning	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	0 to 3.5 hours post radiotracer injection
Primary	Determination of the optimal scan protocol: define optimal scan duration	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	0 to 3.5 hours post radiotracer injection
Primary	Determination of the optimal scan protocol: define optimal dose	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	0 to 3.5 hours post radiotracer injection
Primary	Determination of the optimal scan protocol: evaluation of the added value of furosemide (to improve diuresis), as part of the standard scanprotocol	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	0 to 1.5 hours post radiotracer injection
Secondary	Evaluation of the inter-observer difference for interpretation of [18F]PSMA-11 scans	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	0 - 60 days post [18F]PSMA-11 administration
Secondary	Evaluation of the diagnostic specificity of [18F]PSMA-11	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.	0 - 60 days post [18F]PSMA-11 administration
Secondary	Evaluation of the impact of the [18F]PSMA-11 scan on the choice of therapy	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.	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