Clinical Trial Results:
An exploratory, open label, single-arm study to evaluate the effect of Eligard® 6-month on biomarkers of disease in patients with metastatic prostate cancer
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Summary
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EudraCT number |
2012-000101-69 |
Trial protocol |
NL |
Global end of trial date |
05 Aug 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
13 Aug 2016
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First version publication date |
13 Aug 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 |
EGD-EC-005
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01933022 | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Acronym: EFFECT | ||
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Sponsors
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Sponsor organisation name |
Astellas Pharma Europe Ltd.
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Sponsor organisation address |
2000 Hillswood Drive, Chertsey, Surrey, United Kingdom, KT16 0RS
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Public contact |
Clinical Trial Disclosure, Astellas Pharma Europe Ltd., Astellas.resultsdisclosure@astellas.com
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Scientific contact |
Clinical Trial Disclosure, Astellas Pharma Europe Ltd., Astellas.resultsdisclosure@astellas.com
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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 |
05 Aug 2015
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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 |
05 Aug 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 explore the effect of Eligard® on the following prostate cancer biomarkers:
1. Testosterone in serum
2. Prostate Specific Antigen (PSA) in serum
3. Prostate Cancer Antigen 3 (PCA3) in urine
4. PSA Messenger Ribonucleic Acid (mRNA) in blood/Peripheral Blood Mononuclear Cell
5. PCA3 mRNA in blood/PBMC
6. Transmembrane Protease, Serine 2 Erythroblast Transformation- Specific (ETS)-related gene (TMPRSS2-ERG) mRNA in blood/PBMC
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Protection of trial subjects |
This clinical study was written, conducted and reported in accordance with the protocol, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, and applicable local regulations, including the European Directive 2001/20/EC, on the protection of human rights, and with the ethical principles that have their origin in the Declaration of Helsinki. Astellas ensures that the use and disclosure of protected health information (PHI) obtained during a research study complies with the federal, national and/or regional legislation related to the privacy and protection of personal information.
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Background therapy |
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Evidence for comparator |
- | ||
Actual start date of recruitment |
27 Aug 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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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 |
Netherlands: 2
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Worldwide total number of subjects |
2
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EEA total number of subjects |
2
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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) |
1
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
This multicenter study was conducted at 5 sites in the Netherlands. | ||||||||||
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Pre-assignment
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Screening details |
Participants screened were aged 18 years or older with confirmed metastatic prostate cancer for whom androgen deprivation therapy (ADT) was indicated. 16 participants signed informed consents for entry into the study, of which 14 participants were screen failures. | ||||||||||
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Period 1
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Period 1 title |
Overall period
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||
Blinding implementation details |
This was an open label study.
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Arms
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Arm title
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leuprorelin 45 mg | ||||||||||
Arm description |
Participants received 1 subcutaneous injection of leuprorelin 45 mg 6-months extended release. | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
leuprorelin
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Investigational medicinal product code |
EGD
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Other name |
Eligard®, leuprorelin acetate
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Pharmaceutical forms |
Powder and solvent for solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Leuprorelin 45 mg (6-month formulation of Leuprorelin acetate) powder and solvent for solution was administered subcutaneously (single dose).
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Baseline characteristics reporting groups
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Reporting group title |
leuprorelin 45 mg
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Reporting group description |
Participants received 1 subcutaneous injection of leuprorelin 45 mg 6-months extended release. | ||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
leuprorelin 45 mg
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Reporting group description |
Participants received 1 subcutaneous injection of leuprorelin 45 mg 6-months extended release. | ||
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End point title |
Changes from Baseline of Testosterone Levels in Serum [1] | ||||||||
End point description |
The serum testosterone levels were to be determined using Radio Immuno Assay (RIA). Planned analysis of changes from baseline of clinical evaluation variables was not possible due to small sample size (one study participant) and variations in assay results. Therefore there were no clinical evaluation conclusions made.
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End point type |
Primary
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End point timeframe |
Baseline to week 1, 6, 12 and 24
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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: Not applicable, planned analysis not possible, only one participant completed the study. |
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| Notes [2] - Planned analysis not possible due to small sample size (1 participant). |
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| No statistical analyses for this end point | |||||||||
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End point title |
Changes from Baseline of PSA Level in Serum [3] | ||||||||
End point description |
The serum PSA levels were to be determined using immunoassay. Planned analysis of changes from baseline of clinical evaluation variables was not possible due to small sample size (one study participant) and variations in assay results. Therefore there were no clinical evaluation conclusions made.
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End point type |
Primary
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End point timeframe |
Baseline to week 1, 6, 12 and 24
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| Notes [3] - 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: Not applicable, planned analysis not possible, only one participant completed the study. |
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| Notes [4] - Planned analysis not possible due to small sample size (1 participant). |
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| No statistical analyses for this end point | |||||||||
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End point title |
Changes from Baseline of PCA3 Score in Urine [5] | ||||||||
End point description |
The urine PCA3 scores were to be determined using the PROGENSA® assay. Planned analysis of changes from baseline of clinical evaluation variables was not possible due to small sample size (one study participant) and variations in assay results. Therefore there were no clinical evaluation conclusions made.
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End point type |
Primary
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End point timeframe |
Baseline to week 1, 6, 12 and 24
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| Notes [5] - 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: Not applicable, planned analysis not possible, only one participant completed the study. |
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| Notes [6] - Planned analysis not possible due to small sample size (1 participant). |
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| No statistical analyses for this end point | |||||||||
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End point title |
Changes from Baseline of Number of PSA mRNA Copies in Blood/PBMC [7] | ||||||||
End point description |
The number of PBMC PSA mRNA copies were to be determined by using real time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR). Planned analysis of changes from baseline of clinical evaluation variables was not possible due to small sample size (one study participant) and variations in assay results. Therefore there were no clinical evaluation conclusions made.
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End point type |
Primary
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End point timeframe |
Baseline to week 1, 6, 12 and 24
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| Notes [7] - 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: Not applicable, planned analysis not possible, only one participant completed the study. |
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| Notes [8] - Planned analysis not possible due to small sample size (1 participant). |
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| No statistical analyses for this end point | |||||||||
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End point title |
Changes from Baseline of Number of PCA3 mRNA Copies in Blood/PBMC [9] | ||||||||
End point description |
The number of PBMC PCA3 mRNA copies were to be determined by using real time RT-PCR. Planned analysis of changes from baseline of clinical evaluation variables was not possible due to small sample size (one study participant) and variations in assay results. Therefore there were no clinical evaluation conclusions made.
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End point type |
Primary
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End point timeframe |
Baseline to week 1, 6, 12 and 24
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| Notes [9] - 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: Not applicable, planned analysis not possible, only one participant completed the study. |
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| Notes [10] - Planned analysis not possible due to small sample size (1 participant). |
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| No statistical analyses for this end point | |||||||||
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End point title |
Changes from Baseline of Number of TMPRSS2-ERG mRNA Copies in Blood/PBMC [11] | ||||||||
End point description |
The number of PBMC TMPRSS2-ERG mRNA copies were to be determined by using real time RT-PCR. Planned analysis of changes from baseline of clinical evaluation variables was not possible due to small sample size (one study participant) and variations in assay results. Therefore there were no clinical evaluation conclusions made.
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End point type |
Primary
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End point timeframe |
Baseline to week 1, 6, 12 and 24
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| Notes [11] - 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: Not applicable, planned analysis not possible, only one participant completed the study. |
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| Notes [12] - Planned analysis not possible due to small sample size (1 participant). |
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of Participants with Adverse Events (AEs) | ||||||||||||||||
End point description |
The SAF was the planned analysis population for AEs. An Adverse Event (AE) is defined as any untoward medical occurrence in a participant who was administered study drug & which does not necessarily have a causal relationship with the treatment. An AE starting or worsening after first study drug intake will be considered as treatment emergent (TEAE).
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End point type |
Secondary
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End point timeframe |
From first dose of study drug up to end of study (up to 24 weeks)
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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 first dose of study drug up to end of study (up to 24 weeks)
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Adverse event reporting additional description |
The SAF was the planned analysis population for AEs.
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Assessment type |
Systematic | ||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||
Dictionary version |
17.0
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Reporting groups
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Reporting group title |
Eligard 45 mg
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Reporting group description |
Participants received received 1 subcutaneous injection of Eligard® 45 mg 6-months extended release. | ||||||||||||||||||||||||||
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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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11 Apr 2014 |
1. Inclusion criterion changed from Positive blood PCA3 mRNA at screening to: Positive blood PSA mRNA at screening
2. Exclusion criterion 3, exclusion criterion 9, Previous Drugs and Therapies, and Concomitant Medication wording were updated to allow use of anti-androgens when used to prevent testosterone flare up, starting from up to 2 weeks prior to Eligard® injection and continuing for up to 3 weeks, according to local treatment guidelines.
3. There were 3 other substantial changes, which were administrative changes such as clarification of terminology and contact detail changes. |
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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. | |||
| This study was discontinued/terminated early by the Sponsor due to the lack of feasibility of finding patients meeting all inclusion criteria. | |||
