NCT06387056

Genomic Biomarker-guided Neoadjuvant Therapy for Prostate Cancer (SEGNO)

An Exploratory Study of the Safety and Efficacy of Genomic Biomarker-guided Neoadjuvant Therapy for Locally Advanced and Oligometastatic Prostate Cancer (SEGNO)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The First Affiliated Hospital of Xiamen University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Locally Advanced Prostate Cancer
• Oligometastatic Prostate Cancer

Interventions

Type	Name	Description
DRUG	Rezvilutamide	240mg by mouth once a day for 24 weeks.
DRUG	Goserelin Microspheres for Injection	3.6mg by intramuscular injection once 4 weeks for 24 weeks.
DRUG	Docetaxel	70mg/m2 by infusion every 3 weeks for 6 cycles (each cycle has 3 weeks).
DRUG	Pamiparib	60mg by mouth twice a day for 20 weeks.
DRUG	Cisplatin	70mg/m2 by infusion every 3 weeks for 6 cycles (each cycle has 3 weeks).
DRUG	Tislelizumab	200 mg by infusion every 3 weeks for 6 cycles (each cycle has 3 weeks).

Timeline

• Start date: 2024-04-01
• Primary completion: 2026-04-01
• Completion: 2029-04-01
• First posted: 2024-04-26
• Last updated: 2024-04-26

Locations

1 site across 1 country: China