Phase III Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer
(VIABLE Trial)
Recruiting at176 trial locations
NJ
Overseen byNicholas J. Vogelzang
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Sotio a.s.
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Research Team
NJ
Nicholas J. Vogelzang
Principal Investigator
US Oncology Research/Comprehensive Cancer Centers of Nevada
Eligibility Criteria
Inclusion Criteria
Male 18 years and older.
Histologically or cytologically confirmed prostate adenocarcinoma.
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
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Treatment Details
Interventions
- DCVAC/PCa (Cancer Vaccine)
- Placebo (Other)
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DCVAC/PCa with standard of care chemotherapyExperimental Treatment1 Intervention
Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)
Group II: Placebo with standard of care chemotherapyPlacebo Group1 Intervention
Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
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Who Is Running the Clinical Trial?
Sotio a.s.
Lead Sponsor
Trials
14
Recruited
2,000+
SOTIO a.s.
Lead Sponsor
Trials
16
Recruited
2,200+