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Completed

NCT Number: NCT02107391

Phase II Study of DCVAC/PCa Added to Hormone Therapy for Men With Metastatic Prostate Cancer

The purpose of this study is to determine whether DCVAC/PCa added onto hormone therapy can improve PSA progression times for patients with Metastatic 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

Jablonec nad Nisou, Czechia

Loading trial locations.

About this study

Use of vaccine to improve Prostate Specific Antigen (PSA) levels.

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
  • Presence of bone or soft tissue metastasis (by CT or PET or MRI and/or scintigraphy)
  • Androgen deprivation therapy using Luteinizing-hormone-releasing hormone ( LHRH) analogues commenced at least one month and at most three months prior randomization or orchiectomy performed at least one month and at most three months prior randomization
  • Serum testosterone level at screening (≤ 1.7 nmol/l, resp. ≤ 50 ng/dL)
  • Eastern Cooperative Oncology Group (ECOG) 0-2

Exclusion criteria

  • Confirmed brain and/or leptomeningeal metastases
  • Prior or ongoing chemotherapy 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

Combination therapy with DCVAC/PCA add on to and Standard of Care Hormone Therapy

Leuprolide Acetate

Drug

Standard of Care Hormone Therapy as an Active Comparator

Other names: Lupron

Goserelin acetate

Drug

Standard of Care Hormone Therapy as an Active Comparator

Other names: Zoladex

Primary outcomes

  1. Proportion of patients with PSA Progression

    Time frame: 104 weeks

Secondary outcomes

  1. Proportion of patients with Progression of Disease

    Time frame: 0, 6, 16, 28, 40, 52, 65, 78, 91, 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. Frequency of Skeletal Related Events

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

  4. Changes in Quality of Life (QOL) assessed by EORTC QLQ-C30

    Time frame: 0, 16, 28, 40, 52, 52, 65, 78, 91, 104 weeks

    European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) form C30

  5. Changes in Pain assessed by EORTC QLQ-C30

    Time frame: 0, 16, 28, 40, 52, 52, 65, 78, 91, 104 weeks

    Pain Scale from European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) form C30

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 Combination With Hormone Therapy in Patients With Metastatic Prostate Cancer

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
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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