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

Phase 3

Completed

Conditions: Metastatic Castration-resistant Prostate Cancer

Registration Number: NCT02111577

Lead Sponsor: SOTIO a.s.

Brief Summary: 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.

Detailed Description: This was a randomized, double blind, placebo-controlled, multicenter, international, parallel-group phase III study. Patients with metastatic castration-resistant prostate cancer who were candidates to receive standard of care first-line chemotherapy with docetaxel plus prednisone were randomized 2:1 into one of two arms: an investigational arm (DCVAC/PCa) and a control arm (placebo) in addition to chemotherapy (docetaxel plus prednisone).

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 1182

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overall Survival, Intention-to-treat Population	From randomization to death due to any cause, up to 58 months	Overall survival is defined as the time from randomization until death due to any cause.

Secondary Outcome Measures

Name	Time	Method
Time to PSA Progression, Per Protocol Population	Time from randomization to the date of objective evidence of PSA progression (PSA absolute increase ≥ 2 ng/mL and ≥ 25% above nadir or baseline values providing confirmation by a second consecutive value obtained at least 3 weeks later), up to 39 months	The evidence of PSA progression is defined as: time from randomization to the date of PSA absolute increase ≥ 2 ng/mL and ≥ 25% above nadir or baseline values confirmed by a second consecutive value obtained at least 3 weeks later.
Proportion of Patients With Skeletal-related Events, Per Protocol Population	From randomization to the end of the study, up to 57 months	Progressive disease on bone scans defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan. Skeletal-related events included: * Radiation therapy to bone * Pathologic bone fracture * Spinal cord compression * Surgery to bone * Change in antineoplastic therapy to treat bone pain
Overall Survival, Per Protocol Population	From randomization to death due to any cause, up to 58 months	Overall survival is defined as the time from randomization until death due to any cause.
Overall Survival, Intention-to-treat Population, Abiraterone as Prior Therapy	From randomization to death due to any cause, up to 58 months	Overall survival is defined as the time from randomization until death due to any cause.
Overall Survival, Intention-to-treat Population, Enzalutamide as Prior Therapy	From randomization to death due to any cause, up to 58 months	Overall survival is defined as the time from randomization until death due to any cause.
Radiological Progression-free Survival, Intention-to-treat Population	Time from randomization to the date of the earliest objective evidence of either radiographic progression of bone lesions, radiographic progression of soft tissue lesions, or death due to any cause, up to 58 months	Progressive disease on bone scans was defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan.
Time to First Skeletal-related Event, Intention-to-treat Population	Time from randomization to the date of the first skeletal-related event, up to 58 months	Skeletal-related events included: * Radiation therapy to bone * Pathologic bone fracture * Spinal cord compression * Surgery to bone * Change in antineoplastic therapy to treat bone pain
Proportion of Patients With Skeletal-related Events, Intention-to-treat Population	From randomization to the end of the study, up to 57 months	Progressive disease on bone scans defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan. Skeletal-related events included: * Radiation therapy to bone * Pathologic bone fracture * Spinal cord compression * Surgery to bone * Change in antineoplastic therapy to treat bone pain
Time to PSA Progression, Intention-to-treat Population	Time from randomization to the date of objective evidence of PSA progression (PSA absolute increase ≥ 2 ng/mL and ≥ 25% above nadir or baseline values providing confirmation by a second consecutive value obtained at least 3 weeks later), up to 39 months	The evidence of PSA progression is defined as: time from randomization to the date of PSA absolute increase ≥ 2 ng/mL and ≥ 25% above nadir or baseline values confirmed by a second consecutive value obtained at least 3 weeks later.
Time to First Skeletal-related Event, Per Protocol Population	Time from randomization to the date of the first skeletal-related event, up to 58 months	Skeletal-related events included: * Radiation therapy to bone * Pathologic bone fracture * Spinal cord compression * Surgery to bone * Change in antineoplastic therapy to treat bone pain
Overall Survival, Intention-to-treat Population, no Prior Abiraterone or Enzalutamide	From randomization to death due to any cause, up to 58 months	Overall survival is defined as the time from randomization until death due to any cause.
Radiological Progression-free Survival, Per Protocol Population	Time from randomization to the date of the earliest objective evidence of either radiographic progression of bone lesions, radiographic progression of soft tissue lesions, or death due to any cause, up to 58 months	Progressive disease on bone scans was defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan.
Time to Radiological Progression or Skeletal-related Event, Intention-to-treat Population	Time from randomization to the date of the first radiological progression or skeletal-related event, up to 58 months	Progressive disease on bone scans defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan. Skeletal-related events included: * Radiation therapy to bone * Pathologic bone fracture * Spinal cord compression * Surgery to bone * Change in antineoplastic therapy to treat bone pain
Time to Radiological Progression or Skeletal-related Event, Per Protocol Population	Time from randomization to the date of the first radiological progression or skeletal-related event, up to 58 months	Progressive disease on bone scans defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan. Skeletal-related events included: * Radiation therapy to bone * Pathologic bone fracture * Spinal cord compression * Surgery to bone * Change in antineoplastic therapy to treat bone pain

Trial Locations

Locations (175): University of South Alabama Mitchell Cancer Institute
🇺🇸
Mobile, Alabama, United States
Ironwood Cancer & Research Centers
🇺🇸
Chandler, Arizona, United States
Mayo Clinic
🇺🇸
Scottsdale, Arizona, United States
Compassionate Care Research Group, Inc.
🇺🇸
Riverside, California, United States
California Cancer Associates for Research and Excellence
🇺🇸
Encinitas, 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
Sharp Clinical Oncology Research
🇺🇸
San Diego, California, United States
Oncology Institute of Hope and Innovation
🇺🇸
Whittier, California, United States
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University of South Alabama Mitchell Cancer Institute
🇺🇸Mobile, Alabama, United States