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

NCT03211052 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-07-07

No results posted yet for this study

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.

Conditions

Interventions

DRUG

TAK-700 and LHRH agonist

TAK-700 for 6 months 300mg BD with Leuprorelin Acetate Injections prior to planned prostatectomy

PROCEDURE

prostatectomy

SURGICAL REMOVAL OF THE PROSTATE

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Centre of Experimental Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-18
Primary Completion
2015-06-02
Completion
2015-06-02

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03211052 on ClinicalTrials.gov