18F-PSMA-1007 PET/CT in primary staging of prostate cancer

Molecular Imaging with Fluor-18 PSMA-1007 PET/CT for lymph Node sTaging in primary prostate cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON24419

Enrollment

100

Registered

2018-12-12

Start date

2019-01-01

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

intermediate-high risk prostate cancer, primary staging, diagnostics

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Biopsy proven adenocarcinoma of the prostate; 2. Indication for (super)extended pelvic lymph node dissection (PLND - with or without robot-assisted laparoscopic prostatectomy); 3. Mentally competent and understanding of benefits and potential burden of the study; 4. Written informed consent; 5. Age ¡Ý18 years.

Exclusion criteria

Exclusion criteria: 1. History of prior diagnosed or treated PCa. 2. Known concomitant malignancies (except Basal Cell Carcinoma of the skin). 3. Unwillingness or inability to undergo 18F-PSMA-1007 PET/CT.

Design outcomes

Primary

Measure	Time frame
Diagnostic accuracy (sensitivity, specificity, PPV and NPV) of 18F-PSMA-1007 PET/CT for the detection of (regional) lymph node metastases in the initial staging of intermediate-to high risk PCa patients.	—

Secondary

Measure	Time frame
a. Diagnostic accuracy (specificity, PPV) of 18F-PSMA-1007 PET/CT for the detection of distant (bone) metastases. b. Diagnostic accuracy of 18F-PSMA-1007 PET/CT in staging of the primary tumor in the radical prostatectomy specimen. c. Diagnostic accuracy of 18F-PSMA-1007 PET/CT for different risk groups (according to the d¡¯Amico classification ¨C see chapter 5.1.3), nomogram risk scores, and the size of malignant lymph nodes. d. Diagnostic performance of 18F-PSMA-1007 PET/CT versus conventional imaging (skeletal scintigraphy, MRI of the prostate) in detection of local tumor site and metastases. e. Change of management induced by 18F-PSMA-1007 PET/CT findings specifically. f. Cost-effectiveness of 18F-PSMA-1007 PET/CT versus (super)extended PLND (e.g. mean hospital length of stay, morbidity-associated costs) for the detection of (regional) LNMs.	—

Measure

Time frame

a. Diagnostic accuracy (specificity, PPV) of 18F-PSMA-1007 PET/CT for the detection of distant (bone) metastases. b. Diagnostic accuracy of 18F-PSMA-1007 PET/CT in staging of the primary tumor in the radical prostatectomy specimen. c. Diagnostic accuracy of 18F-PSMA-1007 PET/CT for different risk groups (according to the d¡¯Amico classification ¨C see chapter 5.1.3), nomogram risk scores, and the size of malignant lymph nodes. d. Diagnostic performance of 18F-PSMA-1007 PET/CT versus conventional imaging (skeletal scintigraphy, MRI of the prostate) in detection of local tumor site and metastases. e. Change of management induced by 18F-PSMA-1007 PET/CT findings specifically. f. Cost-effectiveness of 18F-PSMA-1007 PET/CT versus (super)extended PLND (e.g. mean hospital length of stay, morbidity-associated costs) for the detection of (regional) LNMs.

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Outcome results