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Completed

NCT Number: NCT02107404

Phase II Study of DCVAC/PCa Added After Radical Primary Prostatectomy for Patients With Localized Prostate Cancer

The purpose of this study is to determine whether DCVAC/PCa added after radical primary prostatectomy can improve PSA doubling times for patients with 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

Brno, Czechia

Loading trial locations.

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 pT2 prostate cancer
  • Post radical prostatectomy
  • PSA values measured after the value greater than 0.020 ng/mL resulted in PSA doubling time (PSADT) equal or less than 12 months
  • Salvage radiotherapy naïve with PSA increase within 2 years or after salvage radiotherapy with PSA not higher than 1 ng/ml
  • Eastern Cooperative Oncology Group (ECOG) 0-2

Exclusion criteria

  • Confirmed brain and/or leptomeningeal metastases
  • Prior androgen deprivation therapy or orchiectomy for prostate cancer
  • Peripheral neuropathy of Common Toxicity Criteria (CTC) grade 2 or greater
  • Other uncontrolled intercurrent illness
  • Treatment with immunotherapy against prostate cancer
  • 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. Change in Prostate Specific Antigen (PSA) Doubling Time from randomization to week 40

    Time frame: 40 Weeks

Secondary outcomes

  1. Change in PSA Doubling Time during Follow-up from week 40 to 2 years after randomization

    Time frame: 104 Weeks

  2. Frequency of Adverse Events

    Time frame: 0, 2, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 52, 65, 78, 91, 104 weeks

  3. Proportion of Patients with Objective disease progression within 2 years

    Time frame: 104 Weeks

  4. Number of Patients requiring further therapy at 2 years

    Time frame: 104 Weeks

  5. Comparison of PSA Doubling Time in Treatment Phase with Immunotherapy with the Value Prior to Randomization

    Time frame: 104 Weeks

  6. Proportion of patients after RPE with biochemical relapse within 2 years of randomization

    Time frame: 104 Weeks

  7. Proportion of patients with progressive increase in PSA within 2 years of randomization

    Time frame: 104 Weeks

  8. Overall survival

    Time frame: 104 Weeks

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 With Active Cellular Immunotherapy DCVAC/PCa in Patients With Localized Prostate Cancer After Primary Radical Prostatectomy

Important dates

Study start
2012
Primary completion
2015
Study completion
2017
First posted
Apr 8, 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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