PSMA PET/CT for Prostate Cancer

NCT ID: NCT03573011

Last Updated: 2019-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-15
• Study Completion Date: 2019-02-18

Brief 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

2.0 ± 0.2 MBq/kg [18F]PSMA-11 dosing group

To define the optimal [18F]PSMA-11 scan protocol, the quality of the PET images from patients that received 2.0 ± 0.2 MBq/kg will be compared to the images from patients that received 4.0 ± 0.4 MBq/kg.

Patients in this study arm will receive 2.0 ± 0.2 MBq/kg for acquiring the [18F]PSMA-11 scan. All other study parameters and procedures are identical to those in the other study arm.

As for the use of radiopharmaceuticals, the ALARA ('as low as reasonably achievable') principle must be applied, this study arm is considered to be the reference.

Group Type: EXPERIMENTAL

[18F]PSMA-11

Intervention Type: DIAGNOSTIC_TEST

18F-PET imaging

4.0 ± 0.4 MBq/kg [18F]PSMA-11 dosing group

Concerning the dose of \[18F\]PSMA-11, the patients in this study arm will receive 4.0 ± 0.4 MBq/kg for the \[18F\]PSMA-11 scan. All other study parameters and procedures are identical to those in the other study arm

Group Type: EXPERIMENTAL

[18F]PSMA-11

Intervention Type: DIAGNOSTIC_TEST

18F-PET imaging

Interventions

[18F]PSMA-11

18F-PET imaging

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Piet Ost, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

Ghent University Hospital

Ghent, East Flanders, Belgium

Countries

Belgium

References

Piron S, De Man K, Schelfhout V, Van Laeken N, Kersemans K, Achten E, De Vos F, Ost P. Optimization of PET protocol and interrater reliability of 18F-PSMA-11 imaging of prostate cancer. EJNMMI Res. 2020 Feb 24;10(1):14. doi: 10.1186/s13550-020-0593-7.

Reference Type: DERIVED

PMID: 32095919 (View on PubMed)

Other Identifiers

2017-003461-96

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AGO/2017/006 phase 2 trial

Identifier Type: -

Identifier Source: org_study_id