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Completed

NCT Number: NCT02137746

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Hradec Králové, Czechia

Loading trial locations.

About this study

Same as brief summary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dendritic Cells DCVAC/PCa

Biological

DCVAC/PCa Experimental therapy

Primary outcomes

  1. Safety evaluation of the second cycle of DCVAC

    Time frame: 52 weeks

    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.

Secondary outcomes

  1. Time to Prostate Specific Antigen (PSA) Doubling Time

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

SOTIO a.s.

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2017
First posted
May 14, 2014
Registry last updated
May 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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