drugset / Trial / NCT04037254

Testing the Addition of a New Anti-Cancer Drug, Niraparib, to the Usual Treatment (Hormone and Radiation Therapy) for Prostate Cancer With a High Chance of Recurring

NCT04037254

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a phase I-II trial to find the safety and activity of adding a new drug (neraparib) to the usual treatment (radiation combined with male hormone deprivation therapy) in lowering the chance of prostate cancer growing or returning. Niraparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Adding niraparib to the usual care may lower the chance of prostate cancer growing or returning.

Timeline

Start
2019-10-08
Primary completion
2024-07-01
Completion
2025-12-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Niraparib Small molecule 100 mg Oral
Subject Niraparib Small molecule 200 mg Oral