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

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Leuprolide acetate; Biological: Dendritic Cells DCVAC/PCa; Drug: Goserelin Acetate

• Registration Number: NCT02107391
• Lead Sponsor: SOTIO a.s.

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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2014-04-04
• Study First Submitted QC: 2014-04-07
• Study First Posted: 2014-04-08
• Status Verified: 2015-06
• Primary Completion: 2015-12
• Study Completion: 2016-06
• Last Update Submitted: 2017-05-23
• Last Update Posted: 2017-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care Hormone Therapy	Leuprolide acetate	Standard of Care Hormone Therapy as an Active Comparator Goserelin Acetate Leuprolide Acetate
Standard of Care Hormone Therapy	Goserelin Acetate	Standard of Care Hormone Therapy as an Active Comparator Goserelin Acetate Leuprolide Acetate
DCVAC/PCA added Standard Hormone Therapy	Dendritic Cells DCVAC/PCa	Combination therapy with Dendritic Cells DCVAC/PCa added on to a Standard of Care Hormone Therapy

Primary Outcome Measures

Name	Time	Method
Proportion of patients with PSA Progression	104 weeks

Secondary Outcome Measures

Name	Time	Method
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