Phase I Evaluation of Safety and Dosimetry of 68Ga-OncoACP3 in Prostate Cancer Patients with Suspected Metastasis or Recurrence

The primary objective of this Phase I study is to evaluate the **safety** and **dosimetry** of 68Ga-OncoACP3 in patients diagnosed with **prostate cancer**. This evaluation is clinically relevant as it aims to determine the potential of 68Ga-OncoACP3 as a diagnostic tool in various stages of prostate cancer, including cases with suspected metastasis, suspected recurrence indicated by elevated serum prostate-specific antigen (PSA) levels, and metastatic disease where patients might be candidates for treatment with 177Lu-labelled PSMA ligands. The study does not specify any secondary objectives.

The clinical trial involves **patients with prostate cancer** who meet specific criteria, including those with suspected metastasis who are candidates for initial definitive therapy, those with suspected recurrence indicated by an elevated serum prostate-specific antigen (PSA) level greater than 0.2 ng/mL, and those with metastatic disease who might be candidates for treatment with 177Lu-labelled PSMA ligands. The study population is exclusively male, with an age range that includes adults and the elderly. The trial does not include a vulnerable population. The sponsor has not provided information regarding the total number of participants or specific lifestyle considerations such as diet or physical activity. The selection process for the trial population and any additional inclusion or exclusion criteria have not been disclosed by the sponsor.

The clinical trial is a **Phase I** study designed to evaluate the safety and dosimetry of **68Ga-OncoACP3** in patients diagnosed with **prostate cancer**. The trial is structured as a randomized, double-blind, controlled study, ensuring that neither the participants nor the researchers know which treatment the participants are receiving, thus minimizing bias. The estimated duration of the trial is from November 30, 2024, to December 31, 2025, allowing for comprehensive data collection and analysis.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on specific criteria, such as suspected metastasis, suspected recurrence indicated by elevated serum **prostate-specific antigen (PSA)** levels, or metastatic disease potentially treatable with **177Lu-labelled PSMA ligands**. Following the screening, participants will attend regular follow-up visits to monitor their response to the investigational product and to ensure their safety throughout the trial. The end-of-study visit will conclude the participant's involvement, where final assessments will be conducted to gather data on the primary and secondary endpoints.

The expected length of participant involvement in the study is approximately 13 months, from the initial screening to the end-of-study visit. Conditions that may lead to early termination from the study include adverse reactions to the investigational product, withdrawal of consent, or any significant protocol deviations. The trial is conducted under strict ethical guidelines, ensuring the safety and well-being of all participants while contributing valuable data to the understanding of prostate cancer treatment.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available.

Due to the lack of specific data, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be detailed. The absence of this information precludes the provision of a comprehensive description of the treatments used in this clinical trial.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, indicating its primary focus on safety and dosage rather than efficacy. However, preliminary efficacy assessments may still be conducted to gather initial insights. The trial is scheduled to commence recruitment on November 30, 2024, with an estimated completion date of December 31, 2025. Specific parameters or endpoints for efficacy evaluation, such as symptom improvement scores or biomarker levels, are not detailed in the available data. The methods and schedule for measuring, collecting, and analyzing these parameters are also not specified. As a Phase 1 trial, the emphasis will likely be on safety and tolerability, with any efficacy assessments being exploratory in nature. The trial will adhere to standard clinical trial protocols, ensuring that any efficacy data collected is done so in a scientifically rigorous manner.