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

SOTIO

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Biological: Dendritic Cells DCVAC/PCa

Study type: Interventional

Funder types: Industry

Identifiers

NCT02137746

2013-003809-26 (EudraCT Number)

SP010

Details and patient eligibility

About

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.

Full description

Same as brief summary

Enrollment: 24 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

DCVAC/PCa Arm

Experimental group

Description:

Dendritic Cells DCVAC/PCa Experimental therapy

Treatment:

Biological: Dendritic Cells DCVAC/PCa