Dr Choudhury on Potential Future Trials Evaluating Treatment Interruption in mHSPC

Atish D. Choudhury, MD, PhD, senior physician, chair, Gelb Center for Translational Research, Dana-Farber Cancer Center, assistant professor of medicine, Harvard Medical School, discusses the potential and rationale to conduct future prospective trials evaluating the interruption of treatment in patients with metastatic hormone-sensitive prostate cancer (mHSPC) who experience exceptional responses to initial therapy consisting of androgen deprivation therapy (ADT) plus a novel androgen receptor (AR) pathway inhibitor.

This approach is currently being investigated in the phase 2 A-DREAM trial (NCT05241860), which was detailed at the 2024 ASCO Annual Meeting. If findings from this study are positive, Choudhury emphasizes the potential for a larger, randomized trial to compare continuous treatment with intermittent treatment in this patient population. A randomized study could provide more robust data on long-term outcomes and safety with the intermittent approach, he notes.

Incorporating advanced biomarkers, such as imaging-based PET biomarkers, could also represent another key direction for identifying patients who could receive similar benefits with an intermittent approach, Choudhury explains. He highlights the opportunity to integrate these biomarkers to better predict treatment response and guide decisions on when to pause and resume therapy. The use of PET-based biomarkers could refine patient selection and optimize the timing of treatment discontinuation, potentially enhancing the efficacy of intermittent therapy, he explains.

Choudhury also notes ongoing discussions within cooperative groups could determine the optimal design and timing for subsequent studies. These discussions aim to leverage the findings of the A-DREAM trial to inform the development of trials that can validate and expand upon the initial results, he says.

Even before the launch of larger trials, Choudhury suggests that the A-DREAM trial's findings could prompt important clinical discussions between providers and patients with mHSPC regarding treatment duration. If it is found that patients could safely discontinue treatment without increasing the risk of disease relapse, it may encourage shared decision-making regarding the risks and benefits of continuous vs intermittent therapy, he concludes.