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

What Was Tested

This registered phase 2 trial tested Leuprolide.

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.

It had two arms (groups): TAK-700 + LHRH agonist + Prostatectomy (experimental) and Prostatectomy (other).

Neoadjuvant TAK-700 for 6 months with LHRH agonists prior to prostatectomy.

Prostatectomy only-Within 28 days of randomisation.

The registry classes the interventions as drug and procedure.

More on the Plan

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.

Who Took Part

Enrollment: 16 actual participants took part.

It was open to men only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Willing and able to provide written informed consent. No previous treatment for prostate cancer (including surgery, any hormone therapy, radiotherapy, cryotherapy). Age ≥ 18 years and male. Histologically or cytologically confirmed adenocarcinoma of the prostate with Gleason score. A prostate biopsy within 6 months from screening is allowed for entry requirements. Intermediate or high risk prostate cancer according to National Comprehensive Cancer Network (NCCN) risk stratification criteria.

The full record lists 16 inclusion and 21 exclusion criteria; among the exclusions: serious co-existent medical conditions such as chronic active autoimmune disease, (within the last 6 months) or infection (such as hepatitis); patients taking regular oral steroids for any reason; previously treated prostate cancer (including radiotherapy, hormone therapy or surgery).

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Leuprolide group and the comparison group should start out alike.

The Leuprolide group and the comparison group ran side by side rather than switching.

Being open-label, the Leuprolide study did not mask who received what.

It started in 2013-02-18 with completion listed for 2015-06-02.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: 3 year biochemical progression free survival (PSA) (time frame: 3 years).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide in 16 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page, all human trials.