Observational Study of Treatment and ctDNA HRR Testing in Aggressive High-volume Metastatic Hormone-sensitive Prostate Cancer in Russia

What this Trial Is About

Researchers are studying aggressive high-volume metastatic hormone-sensitive prostate cancer mHSPC in male patients in the Russian Federation. This observational study focuses on treatment patterns and the evaluation of homologous recombination repair mutations HRRm in circulating tumor DNA ctDNA. The study aims to better understand demographic and clinical characteristics along with how patients with different HRR gene statuses are treated. The study enrolls about 400 male patients with high-aggressive Gleason 8-10 and high-volume mHSPC who have known tumor HRRm status from routine tumor samples. No additional procedures beyond routine clinical care are performed. Data are collected during two visits a baseline visit where medical history and treatment approaches since diagnosis are recorded, and a final visit at disease progression or after about 12 months to gather follow-up treatment and progression information. Blood samples for ctDNA and HRRm testing are collected from routine blood draws and analyzed centrally. Participants contribute data through medical record reviews and, if needed, patient interviews. Researchers collect information on treatments received, disease progression, lab tests, and mutation presence. The study evaluates various outcomes including treatment proportions, therapy durations, progression times, and mutation rates over 36 months. Data are entered into electronic forms, and follow-up may occur by phone if in-person visits are not possible. The total study duration is about 38 months or until all data are collected.

Aggressive Disease Treatment Patterns and CtDNA HRR evaluatiON in High-volume metastatiC hORmone-sensitive Prostate Cancer in Russian FeDeration