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Completed

NCT Number: NCT02107430

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

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.

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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

Nemocnice Jihlava,Urologické oddělení,, Jihlava, Czechia

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About this study

Treatment post radical primary prostatectomy Treatment post standard radiotherapy

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 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

Treatment and study plan

Dendritic Cells DCVAC/PCa

Biological

DCVAC/PCa arm post radiotherapy

Standard radiotherapy

Radiation

radiotherapy

Primary outcomes

  1. Number of Prostate Specific Antigen (PSA) failures in 5 years

    Time frame: Enrollment up to 260 weeks

    PSA failure per Phoenix criteria of increase of 2ng/mL over nadir

Secondary outcomes

  1. Proportion of Patients without use of salvage therapy within 5 years

    Time frame: Enrollment up to 260 weeks

    Calculation of the proportion of patients without use of salvage therapy within 5 years

  2. Frequency of Adverse Events

    Time frame: enrollment up to 260 weeks

    Safety profile as defined by the nature, incidence, duration, severity and outcome of adverse events

  3. Proportion of Patients without Objective disease progression within 5 years

    Time frame: Enrollment up to 260 weeks

    Proportion of patients who do not have a >2ng/mL elevation in PSA or require salvage therapy

Sponsors and collaborators

Lead sponsor

SOTIO a.s.

Industry

Registry information

Official study title

Randomized, Open-label, Parallel-group, Multi-centre Phase II Clinical Trial of Active Cellular Immunotherapy With Preparation DCVAC/PCa in Patients With Localized High-risk Prostate Cancer After Primary Radiotherapy

Important dates

Study start
2012
Primary completion
2013
Study completion
2018
First posted
Apr 8, 2014
Registry last updated
Nov 14, 2018

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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