Clinical Trial Results:
NEPTUNE: A Randomised Phase II Study of Neoadjuvant TAK-700 and Leuprorelin Acetate versus Surgery Alone in Intermediate and High Risk Clinically Localized Prostate Cancer
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Summary
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EudraCT number |
2012-000478-42 |
Trial protocol |
GB |
Global end of trial date |
16 Jun 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
04 Sep 2016
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First version publication date |
04 Sep 2016
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
008285QM
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
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WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Queen Mary University of London
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Sponsor organisation address |
5 Walden Street, London, United Kingdom, E1 2EF
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Public contact |
Marjia Monsur, Centre for Experimental Cancer Medicine, Queen Mary University of London, London, EC1M 6BQ, +44 02078827351, bci-neptune@qmul.ac.uk
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Scientific contact |
Professor Tom Powles, Centre for Experimental Cancer Medicine, Queen Mary University of London, London, EC1M 6BQ, +44 02078828493, bci-neptune@qmul.ac.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
01 Jun 2016
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
16 Jun 2015
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To investigate if neoadjuvant TAK-700 with LHRH agonists and prostatectomy is associated with an improvement in progression-free survival compared to prostatectomy alone. The primary endpoint will assess the 3 year biochemical progression free survival (PSA)
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Protection of trial subjects |
Both drugs are associated with side effects. These are on the whole due to testosterone reductions in the body. The side effects such as hot flushes and fatigue are common. Erectile dysfunction, which commonly occurs with the prostate surgery could be made worse. Specific side effects associated with orteronel such as swelling can also occur. This was closely monitored during and after the study. Patients on the study arm were required to attend clinic every 4 weeks whilst they were on study medication where adverse events were recorded. The patient information sheet included details on expected adverse events for patients to look out for and also details that unexpected events may occur.
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Background therapy |
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Evidence for comparator |
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Actual start date of recruitment |
01 Mar 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 16
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Worldwide total number of subjects |
16
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EEA total number of subjects |
16
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
7
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From 65 to 84 years |
9
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85 years and over |
0
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Recruitment
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Recruitment details |
Between 5/6/13 and 12/6/14, 16 patients in the United Kingdom with Intermediate and High Risk Clinically Localised Prostate Cancer were recruited to the NEPTUNE study. | |||||||||
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Pre-assignment
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Screening details |
Inclusion criteria included patients with intermediate and high risk clinically localised prostate cancer who had received no previous treatment. 16 patients were randomised (1:1) prior to the early termination of this study. | |||||||||
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Period 1
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Period 1 title |
Overall Trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Neoadjuvant TAK-700,leuprorelin acetate and prostatectomy | |||||||||
Arm description |
Neoadjuvant TAK-700, leuprorelin acetate and prostatectomy | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
TAK-700 (Orteronel)
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Investigational medicinal product code |
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Other name |
TAK-700, Orteronel
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
300mg BID (Daily total dose 600mg) for 24 week period until prostatectomy
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Investigational medicinal product name |
Leuprorelin Acetate
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use, Subcutaneous use
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Dosage and administration details |
3.75mg every 28 days until prostatectomy
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Arm title
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Prostatectomy alone | |||||||||
Arm description |
Prostatectomy alone | |||||||||
Arm type |
No intervention | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Baseline characteristics reporting groups
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Reporting group title |
Overall Trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Neoadjuvant TAK-700,leuprorelin acetate and prostatectomy
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Reporting group description |
Neoadjuvant TAK-700, leuprorelin acetate and prostatectomy | ||
Reporting group title |
Prostatectomy alone
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Reporting group description |
Prostatectomy alone | ||
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End point title |
Biochemical Progression Free Survival [1] | |||||||||
End point description |
Assess the 3 year biochemical progression free survival (PSA) defined as a post-operative serum PSA of greater or equal to 0.2 ng/dl on 2 separate occasions as defined by the AUA.
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End point type |
Primary
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End point timeframe |
From registration until progression
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Due to early termination of the study due to IMP withdrawal from development by the manufacturer, there is insufficient data to perform analysis of this endpoint. |
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| No statistical analyses for this end point | ||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
From date of consent to 30 days post surgery
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
4
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Reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||||||
Date |
Amendment |
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04 Dec 2013 |
-Addition of a participating site
-Updated IMPD
-Changes to the screening procedures- MRI can occur within 16 weeks of randomisation instead of 4 weeks.
-Changes to the time frame in which sites provide screening biopsy to within 8 weeks of randomisation |
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26 Jun 2014 |
-Change of Principal Investigator |
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22 Sep 2014 |
-Implementation of a temporary halt - A manufacturing stop in place concerning the investigational medicinal product ortenerol (TAK-700) by Millenium (Takeda)
-Amended Investigators Brochure (updated safety information)
-Updated Leuprorelin label |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? Yes | |||||||
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Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||||||
| Small numbers precluded any meaningful analysis of any protocol-specified endpoints. | |||||||
