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OpenTrials
Completed

NCT Number: NCT02105675

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

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

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Prostate Cancer Metastatic 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

  • 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

Treatment and study plan

Dendritic Cells DCVAC/PCa

Biological

DCVAC/PCa is the experimental therapy added on to Docetaxel

docetaxel

Drug

Docetaxel is Standard of Care First Line Chemotherapy

Other names: taxotere

Primary outcomes

  1. Survival rate

    Time frame: 135 weeks

Secondary outcomes

  1. Radiographic Progression Free Survival

    Time frame: 135 weeks

  2. Duration to Prostate Specific Antigen (PSA) Progression

    Time frame: 135 weeks

  3. Changes in Quality of Life (QOL) assessed by European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30

    Time frame: 0, 10, 22, 37, 53, 65 weeks

  4. Changes in Pain assessed by EORTC QLQ-C30

    Time frame: 0, 10, 22, 37, 53, 65 weeks

  5. Incidence of Adverse Events

    Time frame: 135 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 of Active Cellular Immunotherapy With Preparation DCVAC/PCa in Patients With Castrate-resistant Prostate Cancer

Important dates

Study start
2012
Primary completion
2014
Study completion
2017
First posted
Apr 7, 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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