A Study of Neoadjuvant TAK-700 and Leuprorelin Acetate Followed by Surgery Versus Surgery Alone — NEPTUNE  

Prostate Cancer Clinical Trial

Official title: A Randomised Phase II Study of Neoadjuvant TAK-700 and Leuprorelin Acetate Followed by Surgery Versus Surgery Alone in Intermediate and High Risk Clinically Localized Prostate Cancer

Status Terminated

Clinical Trial Summary

This study investigates neoadjuvant TAK-700 orteronel for 6 months prior to prostatectomy. The three year biochemical free survival is the primary endpoint. There are a number of 2nd endpoints such as pathological complete response rate, the need for adjuvant radiation therapy, use of post operative radiotherapy an the rate of positive margins at surgery. Translational endpoints include measuring tumoural and plasma testosterone as well as other androgens.

Patients with untreated high risk and intermediate risk operable prostate cancer will be treated with TAK-700 (plus LHRH agonist) for 24 weeks prior to planned prostatectomy.

Clinical Trial Description

Study Objectives:

To investigate if neoadjuvant TAK-700 with LHRH agonists and prostatectomy is associated with a delay in progression free survival compared to prostatectomy alone

To evaluate response (CR and PR) after at least 12 and 24 weeks of treatment with the study drugs Collection of Plasma, tissue and functional imaging with MRI To evaluate (molecular) expression of AR regulated genes and tumour immunohistochemistry. Molecular and protein expression will be correlated with intracellular androgen levels and pathologic response to ADT

136 patients will be randomised to this study. 68 patients will receive neoadjuvant therapy with TAK-700 and Leuprorelin Acetate followed by surgery and 68 patients will receive surgery alone.

This trial aims to recruit 136 patients with clinically localised prostate cancer. Patients will be stratified according to National Comprehensive Cancer Network (NCCN) risk stratification criteria and type of planned surgery. Definitions of risk categories can be found in the inclusion and exclusion criteria. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT03211052
• Study type: Interventional
• Source: Queen Mary University of London
• Status: Terminated
• Phase: Phase 2
• Start date: February 18, 2013
• Completion date: June 2, 2015