PSMA PET/CT for Prostate Cancer

NCT03573011 | Completed Phase 2

• 2 other identifiers: AGO/2017/006 phase 2 trial2017-003461-96
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Keywords

prostate cancer; biochemical recurrence; 18F-PET imaging

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

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

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

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

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

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

  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

Study Arms (2)

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

EXPERIMENTAL

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.

Diagnostic Test: [18F]PSMA-11

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

EXPERIMENTAL

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

Diagnostic Test: [18F]PSMA-11

Interventions

[18F]PSMA-11 DIAGNOSTIC_TEST

18F-PET imaging

2.0 ± 0.2 MBq/kg [18F]PSMA-11 dosing group; 4.0 ± 0.4 MBq/kg [18F]PSMA-11 dosing group

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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, East Flanders, 9000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 32095919 DERIVED

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 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Original phase 2 trial (44 subjects) The assigned \[18F\]PSMA-11 dosing group will be blind to the recruiting physicians, the patient the staff member(s) while planning the \[18F\]PSMA-11 scanday of the patient, 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 dose and the IV injection of this dose are aware of the dose group (2.0 ± 0.2 or 4.0 ± 0.4 MBq/kg body weight), which means that they are NOT blinded. However, these staff members do not carry out any further study specific handlings. Extension phase 2 trial (22 subjects): masking is not applicable for this part of the phase 2 trial.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Original phase 2 (44 subjects) Concerning the dose of \[18F\]PSMA-11, half of the patients in the phase 2 study will be injected with 2.0 ± 0.2 MBq/kg bodyweight. The other half will be injected with 4.0 ± 0.4 MBq/kg body weight. Randomization of patients to one of these two groups will be performed using a block randomization design with block sizes of two, four, and six. Extension phase 2 (22 subjects): For this part of the phase 2 study, all patients will be injected with 2.0 ± 0.2 MBq/kg bodyweight \[18F\]PSMA-11. No Randomisation or masking is applicable for this group of 22 subjects.

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: June 28, 2018
• Study Start: June 15, 2018
• Primary Completion: December 20, 2018
• Study Completion: February 18, 2019
• Last Updated: May 6, 2019

Record last verified: 2019-01

Locations

BE (1)