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Brief Title: Genomic Biomarker-guided Neoadjuvant Therapy for Prostate Cancer (SEGNO)
Official Title: An Exploratory Study of the Safety and Efficacy of Genomic Biomarker-guided Neoadjuvant Therapy for Locally Advanced and Oligometastatic Prostate Cancer (SEGNO)
Study ID: NCT06387056
Brief Summary: To evaluated the safety and efficacy of genomic biomarker-guided neoadjuvant therapy for locally advanced and oligometastatic prostate cancer.
Detailed Description: According to the results of the genomic profile, patients will be assigned to 4 neoadjuvant therapy (NT) groups (Queue 1 to 4): Queue 1: No targetable actionable aberration; Queue 2: Homologous recombination repair (HRR) alterations (BRCA1/2); Queue 3: Homologous recombination repair alterations (except BRCA1/2 and CDK12); Queue 4: MSI-H/dMMR, TMB≥10mut/Mb or CDK12 alterations without other HRR alterations. A following PSMA PETCT for evaluating the efficacy of NT and radical prostatectomy (RP) plus pelvic lymph node dissection (PLND) will be perform. The histopathological and survival data after RP plus PLND will also be evaluated.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China
Name: Kaiyan Zhang, M.D.
Affiliation: The First Affiliated Hospital of Xiamen University
Role: PRINCIPAL_INVESTIGATOR