Phase III Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer

Completed · Phase 3 · Has a placebo group

Conditions studied: Metastatic Castration-resistant Prostate Cancer

In brief

The VIABLE study sought to confirm the hypothesis that the combination of docetaxel with DCVAC/PCa followed by a maintenance therapy with DCVAC/PCa would improve overall survival in patients with metastatic castration-resistant prostate cancer.

Key facts

Study ID

NCT02111577

Run by

SOTIO a.s.

People needed

1182

Starts

2014-05-26

Expected to finish

2020-01-28

Last updated by the study team

2021-04-06

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male 18 years and older.
• Histologically or cytologically confirmed prostate adenocarcinoma.
• Presence of skeletal, or soft-tissue/visceral/nodal metastases according to one of the following criteria:
• Confirmed pathological fracture related to the disease OR
• Confirmation of distant bone and/or soft-tissue and/or visceral metastases on CT or MRI scan or bone scintigraphy OR
• Positive pathology report of metastatic lesion
• Disease progression despite androgen-deprivation therapy (ADT) as indicated by:
• Prostate-specific antigen (PSA) increase that is ≥ 2 ng/mL and ≥ 25% above the minimum PSA as reached during ADT or above the pre-treatment level, if no response was observed and which is confirmed by a second value 1 or more weeks later OR
• Progression of measurable lymph nodes (short axis ≥ 15 mm) or visceral lesion measurable per RECIST v1.1 criteria, confirmation by an independent review facility (IRF) required OR
• Two or more new lesions appearing on bone scan/imaging compared with a previous scan (confirmation by IRF required)
• Maintenance of castrate conditions: patients, who have not had a surgical orchiectomy, must continue with hormone therapy with gonadotropin releasing hormone/ luteinizing hormone-releasing hormone (GnRH/LHRH) agonists or antagonists to reach levels of serum testosterone of ≤ 1.7 nmol/L (50 ng/dL). The duration of the castration period must be at least 4 months before screening as evidenced by combination of clinical/laboratory data (see section 6.8.1).
• Laboratory criteria:
• White blood cells (WBC) greater than 4,000/mm3 (4.0 x109/L)
• Neutrophil count greater than 1,500/mm3 (1.5 x109/L).
• Hemoglobin of at least 10 g/dL (100 g/L).
• Platelet count of at least 100,000/mm3 (100 x 109/L).
• Total bilirubin within normal limits (benign hereditary hyperbilirubinemias, e.g. Gilbert's syndrome, are permitted).
• Serum alanine aminotransferase, aspartate aminotransferase, and creatinine < 1.5x times the upper limit of normal (ULN).
• Life expectancy of at least 6 months based on Investigator's judgment.
• Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
• At least 4 weeks after surgery or radiotherapy before randomization.
• A minimum of 28 days beyond initiation of bisphosphonate or denosumab therapy before randomization.
• Recovery from primary local surgical treatment, radiotherapy or orchiectomy before randomization.
• Signed informed consent including patient's ability to comprehend its contents.

You may not qualify if…

• Confirmed brain and/or leptomeningeal metastases (other visceral metastases are acceptable).
• Current symptomatic spinal cord compression requiring surgery or radiation therapy.
• Prior chemotherapy for prostate cancer.
• Patient co-morbidities:
• Subjects who are not indicated for chemotherapy treatment with first line Standard of Care chemotherapy (docetaxel and prednisone).
• HIV positive, human T-lymphotropic virus positive.
• Active hepatitis B (active hepatitis B), active hepatitis C (HCV), active syphilis.
• Evidence of active bacterial, viral or fungal infection requiring systemic treatment.
• Clinically significant cardiovascular disease including:
• symptomatic congestive heart failure.
• unstable angina pectoris.
• serious cardiac arrhythmia requiring medication.
• uncontrolled hypertension.
• myocardial infarction or ventricular arrhythmia or stroke within a 6 months before screening, known left ventricular ejection fraction (LVEF) < 40% or serious cardiac conduction system disorders, if a pacemaker is not present.
• Pleural and pericardial effusion of any NCI CTCAE grade.
• Peripheral neuropathy having a NCI CTCAE ≥ grade 2.
• History of malignant disease (with the exception of non-melanoma skin tumors) in the preceding five years.
• Active autoimmune disease requiring treatment.
• History of severe forms of primary immune deficiencies.
• History of anaphylaxis or other serious reaction following vaccination.
• Known hypersensitivity to any constituent of the DCVAC/PCa or placebo product.
• Uncontrolled co-morbidities including, psychiatric or social conditions which, in the Investigator's opinion, would prevent participation in the trial.
• Systemic corticosteroids at doses greater than 40 mg hydrocortisone daily or equivalent for any reason other than treatment of PCa within 6 months before randomization.
• Ongoing systemic immunosuppressive therapy for any reason.
• Treatment with anti-androgens, inhibitors of adrenal-produced androgens or other hormonal tumor-focused treatment performed on the day of randomization (except for GnRH/LHRH agonists or antagonists) to exclude possible anti-androgen withdrawal response. This criterion is not applicable to subjects who have never responded to anti-androgen treatment, as there is no risk of anti-androgen withdrawal response.

Where it is running

• Ironwood Cancer & Research Centers — Chandler, Arizona, United States
• Mayo Clinic — Scottsdale, Arizona, United States
• Compassionate Care Research Group, Inc. — Corona, California, United States
• California Cancer Associates for Research and Excellence — Encinitas, California, United States
• Compassionate Care Research Group, Inc. — Fountain Valley, California, United States
• St. Joseph Heritage Healthcare — Fullerton, California, United States
• Hao Wei Zhang, MD, LLC — Los Angeles, California, United States
• Desert Hematology Oncology Medical Group — Rancho Mirage, California, United States
• Compassionate Care Research Group, Inc. — Riverside, California, United States
• Sharp Clinical Oncology Research — San Diego, California, United States
• Oncology Institute of Hope and Innovation — Whittier, California, United States
• Rocky Mountain Cancer Centers — Aurora, Colorado, United States
• University of Colorado — Aurora, Colorado, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• Eastern CT Hematology and Oncololgy Associates — Norwich, Connecticut, United States
• Medstar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Univ. of Miami, Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
• Saint Luke's Cancer Institute — Kansas City, Kansas, United States
• University of Kansas Cancer Center & Medical Pavilion — Westwood, Kansas, United States
• Tulane University — New Orleans, Louisiana, United States
• University of Maryland Greenebaum Cancer Center — Baltimore, Maryland, United States
• Associates In Oncology/Hematology,P.C — Rockville, Maryland, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University of South Alabama Mitchell Cancer Institute — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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