Optimisation of [68Ga] PSMA-11 PET/CT Imaging Protocol for localizing primary prostate cancer prior to radical prostatectomy

Optimisation of [68Ga] PSMA-11 PET/CT Imaging Protocol for localizing primary prostate cancer prior to radical prostatectomy - Optimisation of [68]Ga-PSMA PET/CT protocol

Status

Active, not recruiting

Phases

Phase 3

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43099

Enrollment

Registered

2017-02-03

Start date

2020-09-03

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

first diagnosis Prostate cancer

Interventions

PET/CT

Primairy localised

Prostate cancer

PSMA

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: * Male aged 18 years or older * Ability to provide signed informed consent and willingness to comply with protocol requirements. * Biopsy confirmed presence of adenocarcinoma of the prostate gland * Planned/already executed mpMRI (standard of care). * Planned for radical prostatectomy (standard of care).

Exclusion criteria

Exclusion criteria: * Have any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives, or completing the study. (part A and B) * Have a contraindication for mpMRI. (part A and B) * Will not undergo a radical prostatectomy. (part A and B) * Claustrophobia (part A and B) * Multiple malignancies (part A and B) * Anticoagulant therapy (part A) * Obese (>120 kg) (part A) * Have undergone a transurethral resection of prostate in the past (part A and B)

Design outcomes

Primary

Measure	Time frame
This study aims to determine the optimal kinetic model for 68Ga-PSMA uptake and to design a simplified quantitative model for tracer uptake (Part A).To establish the ideal timing of performing the whole body 68Ga-PSMA PET after administration of the radiotracer and to determine the optimal (quantitative) method for measuring 68Ga-PSMA uptake (Part A). To determine whether it is feasible to exactly identify and localize the tumour within the prostate (Part A and B). To study test-retest characteristics of 68Ga PSMA PET (Part B).	—

Measure

Time frame

This study aims to determine the optimal kinetic model for 68Ga-PSMA uptake and to design a simplified quantitative model for tracer uptake (Part A).To establish the ideal timing of performing the whole body 68Ga-PSMA PET after administration of the radiotracer and to determine the optimal (quantitative) method for measuring 68Ga-PSMA uptake (Part A). To determine whether it is feasible to exactly identify and localize the tumour within the prostate (Part A and B). To study test-retest characteristics of 68Ga PSMA PET (Part B).

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Secondary

Measure	Time frame
Furthermore, we want to determine the test-retest variability of the simplified quantitative model for 68Ga-PSMA that follows from part A (Part B). Secondary, we want to assess if 68Ga-PSMA PET/CT is able to localize and identify tumour tissue within the prostate, compared to mpMRI (Part A and B). - Quantify 68Ga-PSMA uptake kinetics in tumour lesions. - Comparison of 68Ga-PSMA PET (study visit) versus mpMRI (standard of care) regarding to tumour localization within the prostate.	—

Measure

Time frame

Furthermore, we want to determine the test-retest variability of the simplified quantitative model for 68Ga-PSMA that follows from part A (Part B). Secondary, we want to assess if 68Ga-PSMA PET/CT is able to localize and identify tumour tissue within the prostate, compared to mpMRI (Part A and B). - Quantify 68Ga-PSMA uptake kinetics in tumour lesions. - Comparison of 68Ga-PSMA PET (study visit) versus mpMRI (standard of care) regarding to tumour localization within the prostate.

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Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)