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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02107391

Enrollment

Registered

2014-04-08

Start date

2012-03-31

Completion date

2016-06-30

Last updated

2017-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Immunotherapy, Prostate Cancer, Biological, Vaccine, Androgen Deprivation Therapy

Brief summary

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.

Detailed description

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

Interventions

BIOLOGICALDendritic Cells DCVAC/PCa

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

DRUGLeuprolide acetate

Standard of Care Hormone Therapy as an Active Comparator

DRUGGoserelin Acetate

Standard of Care Hormone Therapy as an Active Comparator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Proportion of patients with PSA Progression	104 weeks

Secondary

Measure	Time frame	Description
Proportion of patients with Progression of Disease	0, 6, 16, 28, 40, 52, 65, 78, 91, 104 weeks	—
Frequency of Adverse Events	0, 2, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 52, 65, 78, 91, 104 weeks	—
Frequency of Skeletal Related Events	0, 2, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 52, 65, 78, 91, 104 weeks	—
Changes in Quality of Life (QOL) assessed by EORTC QLQ-C30	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
Changes in Pain assessed by EORTC QLQ-C30	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

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026