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

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

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2018-10-31

Brief Summary

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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.

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Detailed Description

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Treatment post radical primary prostatectomy Treatment post standard radiotherapy

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DCVAC/PCa arm post radiotherapy

Dendritic Cells DCVAC/PCa Experimental therapy post radiotherapy

Group Type EXPERIMENTAL

Dendritic Cells DCVAC/PCa

Intervention Type BIOLOGICAL

DCVAC/PCa arm post radiotherapy

Standard radiotherapy

Standard care

Group Type ACTIVE_COMPARATOR

Dendritic Cells DCVAC/PCa

Intervention Type BIOLOGICAL

DCVAC/PCa arm post radiotherapy

Standard radiotherapy

Intervention Type RADIATION

radiotherapy

Interventions

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Dendritic Cells DCVAC/PCa

DCVAC/PCa arm post radiotherapy

Intervention Type BIOLOGICAL

Standard radiotherapy

radiotherapy

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No