Trial Outcomes & Findings for Phase II Study of Adenovirus/PSA Vaccine in Men With Hormone - Refractory Prostate Cancer (NCT NCT00583024)
NCT ID: NCT00583024
Last Updated: 2023-04-28
Results Overview
To evaluate the increase, decrease, or stable response rates (PSA responses and changes in PSADT) of the Ad/PSA vaccine using a prime-boost immunization strategy. PSADT will be calculated based on the MSKCC online calculator.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
18 months
Results posted on
2023-04-28
Participant Flow
Participant milestones
| Measure |
Adenovirus/PSA Vaccine
ADENOVIRUS/PSA VACCINE: 1x10E8 pfu in Gelfoam subcutaneously on days 0, 30, 60
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Adenovirus/PSA Vaccine
ADENOVIRUS/PSA VACCINE: 1x10E8 pfu in Gelfoam subcutaneously on days 0, 30, 60
|
|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
Baseline Characteristics
Phase II Study of Adenovirus/PSA Vaccine in Men With Hormone - Refractory Prostate Cancer
Baseline characteristics by cohort
| Measure |
Adenovirus/PSA Vaccine
n=32 Participants
ADENOVIRUS/PSA VACCINE: 1x10E8 pfu in Gelfoam subcutaneously on days 0, 30, 60
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
26 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 18 monthsTo evaluate the increase, decrease, or stable response rates (PSA responses and changes in PSADT) of the Ad/PSA vaccine using a prime-boost immunization strategy. PSADT will be calculated based on the MSKCC online calculator.
Outcome measures
| Measure |
Adenovirus/PSA Vaccine
n=26 Participants
ADENOVIRUS/PSA VACCINE: 1x10E8 pfu in Gelfoam subcutaneously on days 0, 30, 60
|
|---|---|
|
Number of Participants With Stable, Decreased, or Increased PSA Doubling Times (PSADT)
Decreased PSADT
|
7 Participants
|
|
Number of Participants With Stable, Decreased, or Increased PSA Doubling Times (PSADT)
Stable PSADT
|
2 Participants
|
|
Number of Participants With Stable, Decreased, or Increased PSA Doubling Times (PSADT)
Increased PSADT or PSA decline
|
17 Participants
|
PRIMARY outcome
Timeframe: 18 monthsStrong or modest antibody responses to PSA measured by the binding to PSA-secreting cell lines
Outcome measures
| Measure |
Adenovirus/PSA Vaccine
n=25 Participants
ADENOVIRUS/PSA VACCINE: 1x10E8 pfu in Gelfoam subcutaneously on days 0, 30, 60
|
|---|---|
|
Number of Participants Who Develop a Strong or Modest Anti-PSA Immune Response
Strong response
|
15 participants
|
|
Number of Participants Who Develop a Strong or Modest Anti-PSA Immune Response
Modest response
|
3 participants
|
SECONDARY outcome
Timeframe: Every 6 months, up to 14 yearsPopulation: 4 patients lost to follow-up
To evaluate survival in evaluable patients receiving the Ad/PSA vaccine, as measured by 2-year, 5-year, 10-year, and overall survival (OS)
Outcome measures
| Measure |
Adenovirus/PSA Vaccine
n=28 Participants
ADENOVIRUS/PSA VACCINE: 1x10E8 pfu in Gelfoam subcutaneously on days 0, 30, 60
|
|---|---|
|
Number of Participants Alive and Deceased Following Treatment
2-year survival · Alive
|
25 Participants
|
|
Number of Participants Alive and Deceased Following Treatment
2-year survival · Deceased
|
3 Participants
|
|
Number of Participants Alive and Deceased Following Treatment
5-year survival · Alive
|
20 Participants
|
|
Number of Participants Alive and Deceased Following Treatment
5-year survival · Deceased
|
8 Participants
|
|
Number of Participants Alive and Deceased Following Treatment
10-year survival · Alive
|
12 Participants
|
|
Number of Participants Alive and Deceased Following Treatment
10-year survival · Deceased
|
16 Participants
|
|
Number of Participants Alive and Deceased Following Treatment
Overall survival · Alive
|
7 Participants
|
|
Number of Participants Alive and Deceased Following Treatment
Overall survival · Deceased
|
21 Participants
|
Adverse Events
Adenovirus/PSA Vaccine
Serious events: 3 serious events
Other events: 18 other events
Deaths: 21 deaths
Serious adverse events
| Measure |
Adenovirus/PSA Vaccine
n=32 participants at risk
ADENOVIRUS/PSA VACCINE: 1x10E8 pfu in Gelfoam subcutaneously on days 0, 30, 60
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary emboli
|
3.1%
1/32 • Number of events 1 • All-Cause Mortality was collected and assessed every 6 months via phone and then via medial record review during long-term follow-up, up to 14 years, AEs collected and recorded at least 4 weeks (30 days) after the last exposure to the study drug (up to day 90).
|
|
Respiratory, thoracic and mediastinal disorders
Obstruction/stenosis of airway - Bronchus
|
3.1%
1/32 • Number of events 1 • All-Cause Mortality was collected and assessed every 6 months via phone and then via medial record review during long-term follow-up, up to 14 years, AEs collected and recorded at least 4 weeks (30 days) after the last exposure to the study drug (up to day 90).
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
3.1%
1/32 • Number of events 1 • All-Cause Mortality was collected and assessed every 6 months via phone and then via medial record review during long-term follow-up, up to 14 years, AEs collected and recorded at least 4 weeks (30 days) after the last exposure to the study drug (up to day 90).
|
Other adverse events
| Measure |
Adenovirus/PSA Vaccine
n=32 participants at risk
ADENOVIRUS/PSA VACCINE: 1x10E8 pfu in Gelfoam subcutaneously on days 0, 30, 60
|
|---|---|
|
General disorders
Headache
|
12.5%
4/32 • Number of events 4 • All-Cause Mortality was collected and assessed every 6 months via phone and then via medial record review during long-term follow-up, up to 14 years, AEs collected and recorded at least 4 weeks (30 days) after the last exposure to the study drug (up to day 90).
|
|
Skin and subcutaneous tissue disorders
Injection site irritation
|
12.5%
4/32 • Number of events 4 • All-Cause Mortality was collected and assessed every 6 months via phone and then via medial record review during long-term follow-up, up to 14 years, AEs collected and recorded at least 4 weeks (30 days) after the last exposure to the study drug (up to day 90).
|
|
General disorders
Cold and flu symptoms
|
15.6%
5/32 • Number of events 5 • All-Cause Mortality was collected and assessed every 6 months via phone and then via medial record review during long-term follow-up, up to 14 years, AEs collected and recorded at least 4 weeks (30 days) after the last exposure to the study drug (up to day 90).
|
|
Skin and subcutaneous tissue disorders
Flushing
|
3.1%
1/32 • Number of events 1 • All-Cause Mortality was collected and assessed every 6 months via phone and then via medial record review during long-term follow-up, up to 14 years, AEs collected and recorded at least 4 weeks (30 days) after the last exposure to the study drug (up to day 90).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.1%
1/32 • Number of events 1 • All-Cause Mortality was collected and assessed every 6 months via phone and then via medial record review during long-term follow-up, up to 14 years, AEs collected and recorded at least 4 weeks (30 days) after the last exposure to the study drug (up to day 90).
|
|
General disorders
Fatigue
|
9.4%
3/32 • Number of events 3 • All-Cause Mortality was collected and assessed every 6 months via phone and then via medial record review during long-term follow-up, up to 14 years, AEs collected and recorded at least 4 weeks (30 days) after the last exposure to the study drug (up to day 90).
|
Additional Information
David Lubaroff, PhD
University of Iowa/Holden Comprehensive Cancer Center
Phone: (319) 335-8423
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place