Clinical Trial Results:
Metabolic changes due to iatrogenic hypogonadism in patients with prostate cancer: orchiectomy vs. triptorelin
Summary
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EudraCT number |
2013-002553-29 |
Trial protocol |
DK |
Global end of trial date |
12 Mar 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
29 Nov 2021
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First version publication date |
29 Nov 2021
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Other versions |
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 |
kk-2013
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Department of Urology
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Sponsor organisation address |
Borgmester Ib Juuls vej 23, Herlev, Denmark, 2730
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Public contact |
Department of Urology, Herlev Hospi, Department of Urology, Herlev Hospital, 0045 38681505, peter.busch.oestergren@regionh.dk
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Scientific contact |
Department of Urology, Herlev Hospi, Department of Urology, Herlev Hospital, 0045 38681505, peter.busch.oestergren@regionh.dk
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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 |
12 Nov 2021
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
12 Mar 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
12 Mar 2016
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Is to investigate if the modality of Androgen deprivation therapy is of importance when looking at body composition, glucose- and lipid metabolism.
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Protection of trial subjects |
This was a phase IV trial comparing 2 well known treatments (surgical orchiectomy vs. triptorelin). Patients were monitored closely for any AEs and SAEs.
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Background therapy |
None | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Sep 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 |
Denmark: 58
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Worldwide total number of subjects |
58
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EEA total number of subjects |
58
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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) |
4
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From 65 to 84 years |
52
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85 years and over |
2
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Recruitment
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Recruitment details |
58 patients were recruited from september 18 2013 until April 3 2015. 78 patients were screened for eligibility. All screening and inclusion was done from a single center in Denmark. | |||||||||||||||||||||
Pre-assignment
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Screening details |
Principle inclusion criteria: 1. diagnosed prostate cancer, where life long ADT is indicated. 2. Age 18 - 90 Years. 3. ECOG Performance status O-2 Principal exclusion criteria: 1. Previous androgen deprivation therapy. 2. Known diabetes mellitus or HbA1c> 48. | |||||||||||||||||||||
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 | |||||||||||||||||||||
Blinding implementation details |
The study was 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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Subcapsular orchiectomy | |||||||||||||||||||||
Arm description |
Subcapsular orchiectomy | |||||||||||||||||||||
Arm type |
Surgical comparator | |||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Triptorelin | |||||||||||||||||||||
Arm description |
Triptorelin 22.5 mg intramuscular every 24 weeks | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
Triptorelin
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Investigational medicinal product code |
PR1
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Other name |
Pamorelin
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Pharmaceutical forms |
Concentrate and solvent for solution for injection/infusion
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Routes of administration |
Intramuscular use
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Dosage and administration details |
22.5mg every 24 weeks
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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 |
Subcapsular orchiectomy
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Reporting group description |
Subcapsular orchiectomy | ||
Reporting group title |
Triptorelin
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Reporting group description |
Triptorelin 22.5 mg intramuscular every 24 weeks |
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End point title |
Fasting plasma glucose | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Measured at baseline, 12, 24 and 48 weeks
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Attachments |
Between group differences in changed glucose measu |
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Statistical analysis title |
Between group difference in fasting glucose | ||||||||||||
Statistical analysis description |
Linear mixed models using generalized least squares were used to analyse the between-group differences in the changes
in the primary endpoint with repeated measures data.
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Comparison groups |
Subcapsular orchiectomy v Triptorelin
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Number of subjects included in analysis |
57
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
0.2
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.1 | ||||||||||||
upper limit |
0.4 |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Adverse event assessment was done from trial start (01.09.2013 until 48 weeks after last patient was included (04.03.2015)
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Adverse event reporting additional description |
AEs were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
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Assessment type |
Systematic | ||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | ||||||||||||||||||||
Dictionary version |
4.0
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Reporting groups
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Reporting group title |
Entire cohort
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Reporting group description |
Men undergoin either orchiectomy or triptorelin injection therapy | ||||||||||||||||||||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Only SAE were systematically reported to sponsor as this was a phase IV trial comparing two well known, and approved, modalities of androgen deprivation therapy (orchiectomy vs. triptorelin). |
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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? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
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. | |||
None reported | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/30388320 http://www.ncbi.nlm.nih.gov/pubmed/27939836 |