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

NCT02107404

SP003 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

DCVAC/PCa Arm

Experimental group

Description:

Dendritic Cells DCVAC/PCA Experimental therapy

Treatment:

Biological: Dendritic Cells DCVAC/PCa

Standard Therapy

No Intervention group

Description:

No Intervention