Phase II Study of DCVAC/PCa After Primary Radiotherapy fo... | NCT02107430

Studies
Phase II Study of DCVAC/PCa After Primary Radiotherapy for Patients With High Risk Localized Prostate Cancer

NCT02107430

Sponsor

SOTIO a.s.

Status

Completed

Last Update Posted

Nov 14, 2018Actual

Enrollment

62Actual

Phase

Phase 2

Conditions

Prostate Cancer

Interventions

Dendritic Cells DCVAC/PCa
Standard radiotherapy

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2011-004967-65	EudraCT Number

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Sep 2013Actual

Completion Date

Oct 2018Actual

First Submitted Date

Apr 4, 2014

First Submission Date that Met QC Criteria

Apr 7, 2014

First Posted Date

Apr 8, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 12, 2018

Last Update Posted Date

Nov 14, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine whether DCVAC/PCa added after radical primary prostatectomy can improve PSA progression times within 5 years for patients with high risk localized Prostate Cancer.

Detailed Description

Treatment post radical primary prostatectomy Treatment post standard radiotherapy

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DCVAC/PCa arm post radiotherapy	Experimental	Dendritic Cells DCVAC/PCa Experimental therapy post radiotherapy	Biological: Dendritic Cells DCVAC/PCa
Standard radiotherapy	Active Comparator	Standard care	Biological: Dendritic Cells DCVAC/PCa Radiation: Standard radiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dendritic Cells DCVAC/PCa	Biological	DCVAC/PCa arm post radiotherapy	DCVAC/PCa arm post radiotherapy Standard radiotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Prostate Specific Antigen (PSA) failures in 5 years	PSA failure per Phoenix criteria of increase of 2ng/mL over nadir	Enrollment up to 260 weeks

Secondary Outcomes

Measure	Description	Time Frame
Proportion of Patients without use of salvage therapy within 5 years	Calculation of the proportion of patients without use of salvage therapy within 5 years	Enrollment up to 260 weeks
Frequency of Adverse Events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male 18 years and older
Histologically confirmed localized prostate cancer of high risk or very high risk fulfilling at least one of the following: T3-T4 stage or Gleason Score 8-10 or PSA level above 20 ng/ml
Indication for prostate cancer radical radiotherapy
Neo-adjuvant androgen androgen-deprivation therapy due to prostate cancer using Luteinizing-hormone-releasing hormone (LHRH) analogues ongoing for at least two months and not longer than 12 months prior randomization
Eastern Cooperative Oncology Group (ECOG) 0-2

Exclusion Criteria:

Primary surgical treatment of prostate cancer
Prior or ongoing chemotherapy for prostate cancer
Participation in other clinical study or administration of other evaluated drug within 30 day prior screening
Unresolved lasting obstruction of urinary system
Other uncontrolled inter-current illness
Treatment with immunotherapy against Prostate Cancer
Clinically significant cardiovascular disease
History of primary immunodeficiency
Active autoimmune disease requiring treatment

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tomas Scheiner	Sotio Biotech Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nemocnice Jihlava,Urologické oddělení,		Jihlava		586 33	Czechia
Fakultní nemocnice Olomouc

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Clinical trial results will be reported as required by European legislation in clinicaltrialsregister.eu.

Types

Not provided

Time Frame

Data will be available 12 months after study completion.

Access Criteria

No specific access criteria are required

URL

https://www.clinicaltrialsregister.eu/ctr-search/search?query=SP004

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided