A Phase I Study of Hydroxychloroquine and Suba-Itraconazole in Men with Biochemical Relapse of Prostate Cancer (HITMAN-PC): Dose Escalation Results

This study established a safe dose for HCQ and SI but found limited clinical efficacy in prostate cancer. Its significance lies in providing proof of biology that this combination alters systemic lipid metabolism. We identified specific plasma lipid species that correlate with clinical outcomes, highlighting the power of embedded biomarker analysis to generate valuable mechanistic insights and candidate biomarkers, even in the absence of a strong clinical response.