A Study of Neoadjuvant TAK-700 and Leuprorelin Acetate Followed by Surgery Versus Surgery Alone (NEPTUNE)
|ClinicalTrials.gov Identifier: NCT03211052|
Recruitment Status : Terminated (IMP no longer available)
First Posted : July 7, 2017
Last Update Posted : July 7, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: TAK-700 and LHRH agonist Procedure: prostatectomy||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||February 18, 2013|
|Actual Primary Completion Date :||June 2, 2015|
|Actual Study Completion Date :||June 2, 2015|
Experimental: TAK-700 + LHRH agonist + Prostatectomy
Neoadjuvant TAK-700 for 6 months with LHRH agonists prior to prostatectomy
Drug: TAK-700 and LHRH agonist
TAK-700 for 6 months 300mg BD with Leuprorelin Acetate Injections prior to planned prostatectomy
Prostatectomy only-Within 28 days of randomisation
SURGICAL REMOVAL OF THE PROSTATE
- 3 year biochemical progression free survival (PSA) [ Time Frame: 3 years ]Post-operative serum PSA of greater or equal to 0.2 ng/dl on 2 separate occasions as defined by the AUA.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211052
|St Bartholomew's Hospital|
|London, United Kingdom|