drugset / Trial / NCT02494713

Hormonal Therapy and Chemotherapy Followed by Prostatectomy in Patients With Prostate Cancer

NCT02494713

NaSingle-groupOpen-labelTreatment

Summary

This is a study for men who have locally-advanced prostate cancer and are eligible to undergo prostatectomy. Standard treatment is prostatectomy alone, but there is a chance that cancer may spread to other organs in the future, even after the prostate is removed. If this were to occur, standard treatment would be androgen deprivation therapy (ADT; hormone therapy that blocks testosterone) plus chemotherapy. Clinical trials suggest that neoadjuvant treatment (treatment given before primary therapy) may prevent a recurrence. The purpose of this research study is to assess the safety and benefit of ADT plus chemotherapy given before prostate removal.

Timeline

Start
2015-10
Primary completion
2017-09-14
Completion
2017-09-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Degarelix Other / unclassified Subcutaneous
Subject Docetaxel Small molecule 35 mg/m2 Intravenous
Subject Doxorubicin Other / unclassified 20 mg/m2 Intravenous
Subject Ketoconazole Small molecule 400 mg Oral
Subject estramustine Other / unclassified 280 mg Oral

Indications