TRACE-II Trial: Combining Radioguided Surgery with ADT for Oligorecurrent Prostate Cancer

What is it about?

The TRACE-II trial is a randomized controlled clinical trial that aims to investigate whether combination treatment of prostate-specific membrane antigen (PSMA)-based radioguided surgery (RGS) with short-term androgen deprivation therapy (ADT) improves oncological outcomes in men with oligorecurrent prostate cancer (PCa) compared to treatment with short-term ADT only. The study will enroll 60 patients, 30 in each arm, and will be powered to detect at least a 30% absolute difference in clinical progression-free survival (CPFS) between the two study arms in the period 2 years after randomization. The expected duration of the study is 5 years. The trial is designed to evaluate the oncological benefit of PSMA-RGS in combination with short-term ADT while maintaining quality of life and limiting the toxicity of hormonal therapy. The primary objective is to determine CPFS at 24 months, and secondary objectives include metastasis-free survival at 2, 5, and 10 years, biochemical progression-free survival at 2 years, and patient-reported quality of life at 2, 5, and 10 years.

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Why is it important?

The study investigates the potential benefits of combining prostate-specific membrane antigen (PSMA)-based radioguided surgery (RGS) with short-term androgen deprivation therapy (ADT) in men with oligorecurrent prostate cancer. The TRACE-II trial aims to determine the clinical progression-free survival (CPFS) at 24 months and other oncological outcomes, such as metastasis-free survival and biochemical progression-free survival, to improve treatment options for patients with this type of cancer. The study's results may contribute to advancing the current treatment approaches for patients with prostate cancer, potentially enhancing quality of life and limiting the toxicity associated with hormonal therapy. Key Takeaways: 1. The TRACE-II trial is a randomised controlled clinical trial investigating the oncological benefits of combining PSMA-RGS with short-term ADT for men with oligorecurrent prostate cancer. 2. The primary objective of the study is to determine CPFS at 24 months, while secondary objectives include metastasis-free survival, biochemical progression-free survival, and patient-reported quality of life. 3. The trial's results may provide valuable insights into improving treatment options and outcomes for patients with prostate cancer.