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

SOTIO

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Biological: Dendritic Cells DCVAC/PCa; Radiation: Standard radiotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT02107430

2011-004967-65 (EudraCT Number)

SP004

Details and patient eligibility

About

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.

Full description

Treatment post radical primary prostatectomy Treatment post standard radiotherapy

Enrollment: 62 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

DCVAC/PCa arm post radiotherapy

Experimental group

Description:

Dendritic Cells DCVAC/PCa Experimental therapy post radiotherapy

Treatment:

Biological: Dendritic Cells DCVAC/PCa

Standard radiotherapy

Active Comparator group

Description:

Standard care

Treatment:

Biological: Dendritic Cells DCVAC/PCa

Radiation: Standard radiotherapy