Study to Allow for Second Treatment Cycle of DCVAC in Patients With Localized Prostate Cancer

NCT ID: NCT02137746

Last Updated: 2017-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2017-03-20

Brief Summary

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The purpose of this study is to assess the safety of the second cycle of DCVAC/PCa in patients who completed the first cycle of DCVAC/PCa in the clinical trial SP003 without an objective progression of the disease.

Detailed Description

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Same as brief summary

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DCVAC/PCa Arm

Dendritic Cells DCVAC/PCa Experimental therapy

Group Type EXPERIMENTAL

Dendritic Cells DCVAC/PCa

Intervention Type BIOLOGICAL

DCVAC/PCa Experimental therapy

Interventions

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Dendritic Cells DCVAC/PCa

DCVAC/PCa Experimental therapy

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Male 18 years and older
* Histologically confirmed prostate adenocarcinoma Stage pathological tumor-2 (pT2)
* Post radical Primary Prostatectomy
* Completion of DCVAC/PCa arm in Study SP003, without objective progression of the disease

Exclusion Criteria

* Prior androgen deprivation therapy for prostate cancer
* Peripheral neuropathy of Common Toxicity Criteria (CTC) grade 2 or greater
* Other uncontrolled intercurrent illness
* Treatment with immunotherapy against PCa
* Clinically significant cardiovascular disease
* Active autoimmune disease requiring treatment
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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SOTIO a.s.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tomas Scheiner, PhD

Role: STUDY_DIRECTOR

Sotio Biotech Inc.

Locations

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Hradec Králové, , Czechia

Site Status

Jablonec nad Nisou, , Czechia

Site Status

Nový Jičín, , Czechia

Site Status

Olomouc, , Czechia

Site Status

Prague, , Czechia

Site Status

Uherské Hradiště, , Czechia

Site Status

Ústí nad Labem, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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2013-003809-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SP010

Identifier Type: -

Identifier Source: org_study_id

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