Evaluation of [18F]PSMA-1007 PET/CT Imaging for Detecting Pelvic Nodal Metastases in High-Risk Prostate Cancer Patients

The primary objective of this study is to evaluate the **sensitivity** and **specificity** of [18F]PSMA-1007 positron-emission, computer-aided tomography (PET-CT) in detecting pelvic nodal metastases (N1) in patients with newly diagnosed high-risk and very-high-risk **prostate cancer**. This assessment is conducted independently by three readers who are blinded to the clinical data, with histology serving as the standard of reference. The clinical relevance of this objective lies in its potential to improve the accuracy of staging in prostate cancer, which is crucial for determining the appropriate therapeutic approach and predicting patient outcomes.

The clinical trial involves a total of **90 male participants** diagnosed with **prostate cancer**. The study population consists of individuals aged 18 years and above, all of whom have newly diagnosed, biopsy-proven, clinically localized prostate adenocarcinoma. Participants have been selected based on their preference for curative prostatectomy with extended pelvic lymph node dissection and must have at least high-risk disease as defined by the NCCN guidelines. The trial does not include female subjects or vulnerable populations. Participants have undergone conventional imaging to detect pelvic nodal involvement and bone or visceral metastases within 60 days prior to the planned PET-CT procedure. The selection criteria ensure that participants are capable of understanding the trial's nature, scope, and consequences, and have provided written informed consent. Lifestyle considerations such as diet, physical activity, or habits are not specified in the available data.

The clinical trial is designed to evaluate the diagnostic performance of **[18F]PSMA-1007** PET/CT imaging in patients with newly diagnosed high-risk or very-high-risk **prostate cancer**. This is a prospective, multi-center study employing a randomized, double-blind, controlled design. The trial aims to assess the sensitivity and specificity of the imaging technique in detecting pelvic nodal metastases (N1) using histology as the standard of reference. The study is expected to commence on January 1, 2024, and conclude by March 31, 2026, with an estimated participant involvement duration of up to one year.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as age, understanding of the trial, and a diagnosis of high-risk prostate adenocarcinoma. Following the screening, participants will be scheduled for the PET-CT procedure within 60 days of conventional imaging. The trial includes follow-up visits to monitor the participants' response to the imaging and any adverse events. The end-of-study visit will conclude the trial for each participant, ensuring all data is collected and any necessary post-trial care is arranged.

The expected length of participant involvement is contingent upon the completion of all required visits and procedures. However, early termination from the study may occur if a participant withdraws consent, experiences adverse events that necessitate discontinuation, or if the study is terminated by the sponsor for any reason. The trial is conducted under strict adherence to ethical guidelines, ensuring the safety and well-being of all participants throughout the study duration.

The clinical trial involves the administration of **Radelumin**, a radiopharmaceutical solution for injection, utilized for diagnostic imaging in patients with newly diagnosed high-risk or very-high-risk prostate cancer. The active substance in Radelumin is **(3S,10S,14S)-1-[4-[[(2S)-4-CARBOXY-2-[(2S)-4-CARBOXY-2-(6-[18F] FLUOROPYRIDIN-3-AMIDO)BUTANAMIDO]BUTANAMIDO]METHYL]PHENYL]-3-[(NAPHTHALEN-2-YL)METHYL]-1,4,12-TRIOXO-2,5,11,13-TETRAAZAHEXADECANE-10,14,16-TRICARBOXYLIC ACID**, also known by its synonyms such as **F-18-PSMA-1007**. This compound is chemically synthesized and is administered as an injectable solution. The pharmaceutical form is a solution for injection, with a concentration of either 1300 MBq/ml or 2000 MBq/ml, depending on the specific product variant used in the trial.

The administration of Radelumin is performed via intravenous injection, with a maximum daily dose of 450 MBq. The total dose administered to each participant does not exceed 450 MBq, and the treatment period is limited to a single day. The dosing schedule is designed to ensure optimal imaging results while maintaining participant safety. Compliance with the dosing regimen is monitored through standard clinical trial procedures, ensuring that each participant receives the correct dosage as per the protocol.

In this study, Radelumin is the primary investigational product, and no additional non-experimental treatments such as placebo or comparator treatments are employed. The trial's objective is to evaluate the diagnostic performance of [18F]PSMA-1007 PET/CT imaging in detecting pelvic nodal metastases in prostate cancer patients. The trial is conducted under the authorization of relevant regulatory bodies, with the product's marketing authorization status confirmed as active in multiple countries, including the Netherlands, France, Germany, and Spain.

The efficacy of the clinical trial will be assessed by evaluating the diagnostic performance of **[18F]PSMA-1007** positron-emission, computer-aided tomography (PET-CT) in detecting pelvic nodal metastases (N1) in patients with newly diagnosed high-risk or very-high-risk prostate cancer. The primary objective is to determine the sensitivity and specificity of this imaging technique in an independent assessment conducted by three readers who are blinded to the clinical data. The standard of reference for this evaluation will be histology. The trial will focus on a region-based patient-level analysis, ensuring that at least one hemi-pelvis is correctly diagnosed.