Phase II Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Randomized, Open-label, Parallel-group, Multi-centre Phase II Clinical Trial of Active Cellular Immunotherapy With Preparation DCVAC/PCa in Patients With Castrate-resistant Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02105675
• Other study ID #: SP001
• Secondary ID: 2011-004735-32
• Status: Completed
• Phase: Phase 2
• First received: March 24, 2014
• Last updated: May 23, 2017
• Start date: February 2012
• Est. completion date: February 20, 2017

Study information

• Verified date: June 2015
• Source: Sotio a.s.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether DCVAC/PCa added onto Standard of Care therapy can improve survival times for patients with Metastatic Castration Resistant Prostate Cancer

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 20, 2017
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men aged = 18 years

• Histologically confirmed prostate cancer

• Presence of skeletal metastasis (by CT or PET or MRI)

• Disease progression documented by increasing PSA or two new lesions

• Eastern Cooperative Oncology Group (ECOG) Performance status 0-2

Exclusion Criteria:

• Confirmed brain and/or leptomeningeal metastases

• Prior chemotherapy 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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostate Cancer Metastatic
• Prostatic Neoplasms

Intervention

Biological:
• Dendritic Cells DCVAC/PCa
DCVAC/PCa is the experimental therapy added on to Docetaxel

Drug:
• Docetaxel
Docetaxel is Standard of Care First Line Chemotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sotio a.s.

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate		135 weeks
Secondary	Radiographic Progression Free Survival		135 weeks
Secondary	Duration to Prostate Specific Antigen (PSA) Progression		135 weeks
Secondary	Changes in Quality of Life (QOL) assessed by European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30		0, 10, 22, 37, 53, 65 weeks
Secondary	Changes in Pain assessed by EORTC QLQ-C30		0, 10, 22, 37, 53, 65 weeks
Secondary	Incidence of Adverse Events		135 weeks