Evaluation of PSMA-Targeted Radionuclide Therapy in Adults with Metastatic Clear Cell Renal Cancer Post Anti-VEGFR and Immunotherapy Treatment

The primary objective of this study is to evaluate the efficacy of **PSMA targeted radionuclide therapy** in adult patients with **metastatic clear cell renal cancer** who have experienced progressive disease following two lines of therapy in the advanced or metastatic setting, including at least one line of anti-VEGFR therapy and one line of immunotherapy. This evaluation is clinically relevant as it aims to address the therapeutic needs of patients with limited treatment options due to disease progression after standard therapies.

The clinical trial involves participants diagnosed with **metastatic clear cell renal cancer** who have experienced progressive disease following two lines of therapy in the advanced or metastatic setting, including at least one line of anti-VEGFR and one line of immunotherapy. The study population includes both male and female subjects, with an age range corresponding to categories 3 and 4, which typically represent adults and older adults. The trial population selection criteria include individuals from a vulnerable population. However, the sponsor has not provided the total number of participants involved in the study. The trial does not specify any particular lifestyle considerations such as diet, physical activity, or habits. Key inclusion or exclusion criteria have not been detailed by the sponsor.

The clinical trial is designed to evaluate the efficacy of **PSMA targeted radionuclide therapy** in adult patients diagnosed with **metastatic clear cell renal cancer**. This study targets individuals who have shown progressive disease after undergoing two lines of therapy in the advanced or metastatic setting, which must include at least one line of anti-VEGFR and one line of immunotherapy. The trial is structured as a randomized, double-blind, controlled study, ensuring that neither the participants nor the researchers know who is receiving the experimental treatment versus a placebo, thereby minimizing bias and enhancing the reliability of the results.

The trial is expected to commence recruitment on June 12, 2023, and is projected to conclude by June 15, 2026. Participants will be involved in the study for its entire duration unless specific conditions necessitate early termination. Such conditions may include adverse reactions to the treatment, withdrawal of consent, or any other medical or ethical reasons deemed significant by the study investigators.

The sequence of study visits begins with an inclusion (screening) visit, where potential participants are assessed for eligibility based on the study's inclusion and exclusion criteria. Following successful enrollment, participants will undergo a series of follow-up visits at predetermined intervals to monitor their response to the therapy and to collect data on safety and efficacy. The end-of-study visit will mark the conclusion of the participant's involvement, during which final assessments will be conducted to gather comprehensive data on the treatment's impact.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or frequency of administration. As such, no detailed description of the experimental treatment can be provided based on the available data.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Consequently, no description of these elements can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be elaborated upon in this context.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is set to commence recruitment on June 12, 2023, with an estimated completion date of June 15, 2026. The trial is categorized under phase 9, indicating an advanced stage of clinical research. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, the trial will likely employ standard methodologies for measuring and analyzing efficacy outcomes. These may include validated scales, laboratory tests, or patient-reported outcomes, assessed at predetermined timepoints throughout the trial duration. The absence of explicit endpoints suggests a focus on comprehensive data collection to evaluate the therapeutic impact of the intervention under investigation.