Phase III Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer (VIABLE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02111577 |
Recruitment Status :
Completed
First Posted : April 11, 2014
Results First Posted : April 6, 2021
Last Update Posted : April 6, 2021
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Sponsor:
SOTIO a.s.
Information provided by (Responsible Party):
SOTIO Biotech ( SOTIO a.s. )
- Study Details
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
Condition |
Metastatic Castration-resistant Prostate Cancer |
Interventions |
Biological: DCVAC/PCa Biological: Placebo |
Enrollment | 1182 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | DCVAC/PCa With Standard of Care Chemotherapy | Placebo With Standard of Care Chemotherapy |
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Combination therapy with dendritic cell vaccine for prostate cancer (DCVAC/PCa) and standard of care chemotherapy (docetaxel and prednisone) | Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator |
Period Title: Overall Study | ||
Started | 787 | 395 |
Completed | 188 | 106 |
Not Completed | 599 | 289 |
Reason Not Completed | ||
Protocol Violation | 2 | 0 |
Unable to tolerate leukapheresis | 1 | 0 |
Failure to produce study treatment | 6 | 0 |
Death | 518 | 254 |
Medical monitor's decision (active hepatitis B) | 1 | 0 |
Adverse Event | 1 | 1 |
Withdrawal by Subject | 51 | 23 |
Disease progression | 0 | 1 |
Lost to Follow-up | 19 | 10 |
Baseline Characteristics
Arm/Group Title | DCVAC/PCa With Standard of Care Chemotherapy | Placebo With Standard of Care Chemotherapy | Total | |
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Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone) | Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator | Total of all reporting groups | |
Overall Number of Baseline Participants | 787 | 395 | 1182 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 787 participants | 395 participants | 1182 participants | |
<=18 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Between 18 and 65 years |
272 34.6%
|
107 27.1%
|
379 32.1%
|
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>=65 years |
515 65.4%
|
288 72.9%
|
803 67.9%
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Age, Continuous
Median (Full Range) Unit of measure: Years |
||||
Number Analyzed | 787 participants | 395 participants | 1182 participants | |
68.0
(46 to 89)
|
69.0
(46 to 89)
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68.0
(46 to 89)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 787 participants | 395 participants | 1182 participants | |
Female |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Male |
787 100.0%
|
395 100.0%
|
1182 100.0%
|
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 787 participants | 395 participants | 1182 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Asian |
5 0.6%
|
4 1.0%
|
9 0.8%
|
|
Native Hawaiian or Other Pacific Islander |
1 0.1%
|
0 0.0%
|
1 0.1%
|
|
Black or African American |
26 3.3%
|
19 4.8%
|
45 3.8%
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White |
733 93.1%
|
358 90.6%
|
1091 92.3%
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More than one race |
4 0.5%
|
3 0.8%
|
7 0.6%
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|
Unknown or Not Reported |
18 2.3%
|
11 2.8%
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29 2.5%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
||||
Hungary | Number Analyzed | 787 participants | 395 participants | 1182 participants |
28 | 14 | 42 | ||
United States | Number Analyzed | 787 participants | 395 participants | 1182 participants |
144 | 73 | 217 | ||
Czechia | Number Analyzed | 787 participants | 395 participants | 1182 participants |
102 | 40 | 142 | ||
United Kingdom | Number Analyzed | 787 participants | 395 participants | 1182 participants |
60 | 36 | 96 | ||
Belarus | Number Analyzed | 787 participants | 395 participants | 1182 participants |
13 | 18 | 31 | ||
Portugal | Number Analyzed | 787 participants | 395 participants | 1182 participants |
20 | 10 | 30 | ||
Spain | Number Analyzed | 787 participants | 395 participants | 1182 participants |
18 | 14 | 32 | ||
Austria | Number Analyzed | 787 participants | 395 participants | 1182 participants |
14 | 5 | 19 | ||
Latvia | Number Analyzed | 787 participants | 395 participants | 1182 participants |
0 | 2 | 2 | ||
Netherlands | Number Analyzed | 787 participants | 395 participants | 1182 participants |
29 | 19 | 48 | ||
Sweden | Number Analyzed | 787 participants | 395 participants | 1182 participants |
4 | 1 | 5 | ||
Belgium | Number Analyzed | 787 participants | 395 participants | 1182 participants |
20 | 11 | 31 | ||
Denmark | Number Analyzed | 787 participants | 395 participants | 1182 participants |
2 | 0 | 2 | ||
Poland | Number Analyzed | 787 participants | 395 participants | 1182 participants |
94 | 36 | 130 | ||
Italy | Number Analyzed | 787 participants | 395 participants | 1182 participants |
19 | 3 | 22 | ||
Slovakia | Number Analyzed | 787 participants | 395 participants | 1182 participants |
49 | 15 | 64 | ||
Bulgaria | Number Analyzed | 787 participants | 395 participants | 1182 participants |
15 | 10 | 25 | ||
France | Number Analyzed | 787 participants | 395 participants | 1182 participants |
18 | 12 | 30 | ||
Lithuania | Number Analyzed | 787 participants | 395 participants | 1182 participants |
6 | 5 | 11 | ||
Serbia | Number Analyzed | 787 participants | 395 participants | 1182 participants |
22 | 14 | 36 | ||
Germany | Number Analyzed | 787 participants | 395 participants | 1182 participants |
92 | 51 | 143 | ||
Croatia | Number Analyzed | 787 participants | 395 participants | 1182 participants |
18 | 6 | 24 | ||
Prostate-specific antigen
[1] Median (Full Range) Unit of measure: ng/L |
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Number Analyzed | 786 participants | 394 participants | 1180 participants | |
46.35
(0.0 to 7500.0)
|
54.02
(0.1 to 5000.0)
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47.87
(0.0 to 7500.0)
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[1]
Measure Analysis Population Description: PSA available for 786 patients in the experimental arm (DCVAC/PCa) and 394 patients in the control arm (placebo)
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Any formal publication of clinical trial results will be a collaborative effort between the sponsor and the investigator(s). All manuscripts or abstracts will be reviewed and approved in written by the sponsor before submission. The sponsor may request a delay in publication if there are important intellectual property concerns but does not have the right to suppress the publication of the clinical trial results indefinitely.
Results Point of Contact
Name/Title: | Prof. Radek Spisek, M.D., Ph.D. |
Organization: | SOTIO a.s. |
Phone: | +420 2241 75101 |
EMail: | spisek@sotio.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | SOTIO Biotech ( SOTIO a.s. ) |
ClinicalTrials.gov Identifier: | NCT02111577 |
Other Study ID Numbers: |
SP005 2012-002814-38 ( EudraCT Number ) |
First Submitted: | April 9, 2014 |
First Posted: | April 11, 2014 |
Results First Submitted: | January 22, 2021 |
Results First Posted: | April 6, 2021 |
Last Update Posted: | April 6, 2021 |