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

SOTIO

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Goserelin Acetate; Drug: Leuprolide acetate; Biological: Dendritic Cells DCVAC/PCa

Study type: Interventional

Funder types: Industry

Identifiers

NCT02107391

SP002

2011-004986-34 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 63 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

63 participants in 2 patient groups

DCVAC/PCA added Standard Hormone Therapy

Experimental group

Description:

Combination therapy with Dendritic Cells DCVAC/PCa added on to a Standard of Care Hormone Therapy

Treatment:

Biological: Dendritic Cells DCVAC/PCa

Standard of Care Hormone Therapy

Active Comparator group

Description:

Standard of Care Hormone Therapy as an Active Comparator Goserelin Acetate Leuprolide Acetate

Treatment:

Drug: Leuprolide acetate

Drug: Goserelin Acetate