drugset / Trial / NCT02716974

A Study of Definitive Therapy to Treat Prostate Cancer

NCT02716974

NaSingle-groupOpen-labelTreatment

Summary

To assess the safety of treating men with oligometastatic prostate cancer with the following therapy: (1st) Systemic chemo-hormonal therapy with up to 6-months (\~24 weeks) of neoadjuvant androgen deprivation and up to 6 cycles of chemotherapy, (2nd) definitive local tumor control with prostatectomy +/- adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 1 year of androgen deprivation. Androgen blockade will be the same throughout the course of treatment.

Timeline

Start
2016-06
Primary completion
2022-04
Completion
2022-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Bicalutamide Other / unclassified 50 mg Oral
Subject Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Leuprolide Other / unclassified 22.5 mg Intramuscular

Indications