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

Prostate Cancer Clinical Trial

Official title:

Open-label, One-arm, Multi-centre Phase II Clinical Trial Treated With Second Cycle of Active Cellular Immunotherapy With DCVAC/PCa in Patients With Localized Prostate Cancer After Primary Radical Prostatectomy Without Objective Progression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02137746
• Other study ID #: SP010
• Secondary ID: 2013-003809-26
• Status: Completed
• Phase: Phase 2
• First received: May 12, 2014
• Last updated: May 23, 2017
• Start date: December 2013
• Est. completion date: March 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 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.

Description:

Same as brief summary

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 20, 2017
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• Dendritic Cells DCVAC/PCa
DCVAC/PCa Experimental therapy

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	Safety evaluation of the second cycle of DCVAC	Safety evaluation of the second cycle of active cellular immunotherapy, which includes a second leukapheresis procedure, who after primary radical prostatectomy completed first cycle of active cellular immunotherapy in clinical trial SP003 without objective disease progression requiring additional anti-tumor therapy.	52 weeks
Secondary	Time to Prostate Specific Antigen (PSA) Doubling Time		52 weeks