Phase II Study of DCVAC/PCa Added After Radical Primary Prostatectomy for Patients With 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

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2017-05-22

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 doubling times for patients with localized Prostate Cancer.

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Detailed Description

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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

Dendritic Cells DCVAC/PCA Experimental therapy

Group Type EXPERIMENTAL

Dendritic Cells DCVAC/PCa

Intervention Type BIOLOGICAL

DCVAC/PCa Experimental therapy

Standard Therapy

No Intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

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 pT2 prostate cancer
* Post radical prostatectomy
* PSA values measured after the value greater than 0.020 ng/mL resulted in PSA doubling time (PSADT) equal or less than 12 months
* Salvage radiotherapy naïve with PSA increase within 2 years or after salvage radiotherapy with PSA not higher than 1 ng/ml
* Eastern Cooperative Oncology Group (ECOG) 0-2

Exclusion Criteria

* Confirmed brain and/or leptomeningeal metastases
* Prior androgen deprivation therapy or orchiectomy for prostate cancer
* Peripheral neuropathy of Common Toxicity Criteria (CTC) grade 2 or greater
* Other uncontrolled intercurrent illness
* Treatment with immunotherapy against prostate cancer
* Clinically significant cardiovascular disease
* Active autoimmune disease requiring treatment

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No