Clinical trial NCT02107391: Phase II Study of DCVAC/PCa Added to Hormone Therapy for Men With Metastatic Prostate Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Immunotherapy
Prostate Cancer
Biological
Vaccine
Androgen Deprivation Therapy
Lead sponsor: Sotio Biotech Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-08
Enrollment: 63
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients with PSA Progression
timeFrame: 104 weeks
Secondary outcomes:
measure: Proportion of patients with Progression of Disease
timeFrame: 0, 6, 16, 28, 40, 52, 65, 78, 91, 104 weeks
measure: Frequency of Adverse Events
timeFrame: 0, 2, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 52, 65, 78, 91, 104 weeks
measure: Frequency of Skeletal Related Events
timeFrame: 0, 2, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 52, 65, 78, 91, 104 weeks
measure: Changes in Quality of Life (QOL) assessed by EORTC QLQ-C30
timeFrame: 0, 16, 28, 40, 52, 52, 65, 78, 91, 104 weeks
measure: Changes in Pain assessed by EORTC QLQ-C30
timeFrame: 0, 16, 28, 40, 52, 52, 65, 78, 91, 104 weeks
Other outcomes:
Locations:
city: Jablonec nad Nisou
country: Czechia
city: Jihlava
country: Czechia
city: Liberec
country: Czechia
city: Mnisek pod Brdy
country: Czechia
city: Olomouc
country: Czechia
city: Plzen
country: Czechia
city: Praha 10
country: Czechia
city: Praha 4
country: Czechia
city: Praha 5
country: Czechia
city: Praha 8
country: Czechia
city: Usti nad Labem
country: Czechia
city: Zlin
country: Czechia
Study officials:
affiliation: Sotio-Accord
name: Tomas Scheiner, PhD
role: STUDY_DIRECTOR
References: