Prostate Cancer
Conditions
Brief summary
The investigators are trying to find new methods to treat prostate cancer. The approach the investigators are taking is to try to enhance patients' own immune response against the cancer. In this study the investigators will be testing the effectiveness of a vaccine that may be able to help the body fight prostate cancer.
Interventions
BIOLOGICALpTVG-HP
pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
BIOLOGICALrhGM-CSF
rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologic diagnosis of adenocarcinoma of the prostate * Completion of local therapy by surgery and/or ablative radiation therapy at least 3 months prior to entry, with removal or ablation of all visible disease, including seminal vesical and/or local lymph node involvement * Rising prostate specific antigen (PSA) levels without scan evidence of metastatic disease * Asymptomatic or mildly symptomatic and life expectancy of at least 4 months
Exclusion criteria
* Small cell or other variant prostate cancer histology * Evidence of immunosuppression * Prior treatment with androgen deprivation except if given neoadjuvantly or adjuvantly with radiation therapy or at time of prostatectomy. In this situation, no more than 24 months of androgen deprivation must have been given and treatment must not have been within 12 months prior to screening for this study. * Serum testosterone at screening \< 50 ng/dL * Known bone metastases or lymph node involvement as determined by bone scan or computed tomography (CT) scan of the abdomen and pelvis within 4 weeks of study entry * Prior vaccine therapy for prostate cancer * Known allergic reactions to granulocyte-macrophage colony-stimulating factor (GM-CSF) * Severe intercurrent medical conditions or laboratory abnormalities that would impart, in the judgment of the Medical Monitor, excess risk associated with study participation or study agent administration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-year Metastasis-Free Survival Rate | 2 years | 2-year Metastasis-Free Survival (MFS) Rate with the development of metastases by conventional imaging used to define progression (as defined by RECIST 1.1 criteria). The 2-year MFS rate estimates which were obtained using the Kaplan-Meier analysis (taking into account censoring) using the intention-to-treat population. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prostate Specific Antigen (PSA) Doubling Time (DT) | up to 9 months | PSA DT was calculated using all serum PSA values available from the same clinical laboratory for the specified period by the equation log2/b where b denotes the least-squares estimator of the linear regression model of the log-transformed PSA values on time. Pretreatment PSA DT (3-6 months before treatment, with a minimum of 4 values), on-treatment PSA DT was determined using values from month 3 to month 9. |
| Number and Severity of Observed Toxicities | 2 years | Number of participants who experienced any adverse events greater than grade 1 that were determined to be at least possibly related to treatment, highest grade reported per participant for each adverse event (AE). All toxicities were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (version 4). Higher grades indicate more severe toxicities. |
| Median Time to Radiographic Disease Progression | up to 2 years | Time to metastasis was determined from the date of registration to the first CT or bone scan that demonstrated metastatic disease. As defined by RECIST 1.1 criteria. |
| PSA Progression Free Survival | up to 2 years | — |
Countries
United States
Participant flow
Recruitment details
Ninety-nine participants were enrolled between 2011 and 2016 at the University of Wisconsin; University of California, San Francisco; and Johns Hopkins University.
Participants by arm
| Arm | Count |
|---|---|
| GM-CSF Alone rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
rhGM-CSF: rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period | 49 |
| pTVG-HP Vaccine With GM-CSF pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
pTVG-HP: pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period | 48 |
| Total | 97 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Incorrect Random Assignment | 0 | 1 |
| Overall Study | ineligible; presence metastatic disease | 0 | 1 |
Baseline characteristics
| Characteristic | pTVG-HP Vaccine With GM-CSF | Total | GM-CSF Alone |
|---|---|---|---|
| Age, Continuous | 71 years | 71 years | 71 years |
| Baseline Prostate-Specific Antigen (PSA) 2.0 - 10.0 ng/mL | 40 Participants | 82 Participants | 42 Participants |
| Baseline Prostate-Specific Antigen (PSA) greater than 10 ng/mL | 8 Participants | 15 Participants | 7 Participants |
| Baseline PSA Doubling Time 3-6 months | 21 Participants | 43 Participants | 22 Participants |
| Baseline PSA Doubling Time 6-12 months | 16 Participants | 33 Participants | 17 Participants |
| Baseline PSA Doubling Time less than 3 months | 11 Participants | 21 Participants | 10 Participants |
| Gleason Score greater than 7 | 16 Participants | 31 Participants | 15 Participants |
| Gleason Score less than or equal to 7 | 32 Participants | 66 Participants | 34 Participants |
| Prior Treatment Adjuvant Radiation Therapy | 31 Participants | 59 Participants | 28 Participants |
| Prior Treatment Androgen Deprivation | 15 Participants | 28 Participants | 13 Participants |
| Prior Treatment Chemotherapy | 1 Participants | 2 Participants | 1 Participants |
| Prior Treatment Primary Radiation Therapy | 12 Participants | 32 Participants | 20 Participants |
| Prior Treatment Prostatectomy | 41 Participants | 75 Participants | 34 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) White | 43 Participants | 89 Participants | 46 Participants |
| Region of Enrollment United States | 48 participants | 97 participants | 49 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 48 Participants | 97 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 50 |
| other Total, other adverse events | 45 / 49 | 49 / 50 |
| serious Total, serious adverse events | 6 / 49 | 3 / 50 |
Outcome results
Primary
2-year Metastasis-Free Survival Rate
2-year Metastasis-Free Survival (MFS) Rate with the development of metastases by conventional imaging used to define progression (as defined by RECIST 1.1 criteria). The 2-year MFS rate estimates which were obtained using the Kaplan-Meier analysis (taking into account censoring) using the intention-to-treat population.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GM-CSF Alone | 2-year Metastasis-Free Survival Rate | 42.3 percent probability |
| pTVG-HP Vaccine With GM-CSF | 2-year Metastasis-Free Survival Rate | 41.8 percent probability |
p-value: 0.97Mantel Haenszel
Secondary
Median Time to Radiographic Disease Progression
Time to metastasis was determined from the date of registration to the first CT or bone scan that demonstrated metastatic disease. As defined by RECIST 1.1 criteria.
Time frame: up to 2 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| GM-CSF Alone | Median Time to Radiographic Disease Progression | 18.3 months |
| pTVG-HP Vaccine With GM-CSF | Median Time to Radiographic Disease Progression | 18.9 months |
p-value: 0.1495% CI: [0.9, 2.8]Regression, Cox
Secondary
Number and Severity of Observed Toxicities
Number of participants who experienced any adverse events greater than grade 1 that were determined to be at least possibly related to treatment, highest grade reported per participant for each adverse event (AE). All toxicities were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (version 4). Higher grades indicate more severe toxicities.
Time frame: 2 years
Population: Number of Severity of Adverse Events (AE) by grade complements the Adverse Events Section of this record.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| GM-CSF Alone | Number and Severity of Observed Toxicities | Nausea | Grade 3 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Myalgia | Grade 2 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Decreased ANC | Grade 3 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Myalgia | Grade 3 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Nausea | Grade 4 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Myalgia | Grade 4 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Decreased WBC | Did not experience this AE | 49 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Myalgia | Did not experience this AE | 49 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Nausea | Did not experience this AE | 49 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Headache | Grade 2 | 1 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Fatigue | Grade 3 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Headache | Grade 3 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Allergic Reaction | Grade 3 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Headache | Grade 4 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Fatigue | Grade 4 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Headache | Did not experience this AE | 48 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Paresthesia | Grade 2 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Allergic Reaction | Grade 4 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Paresthesia | Grade 3 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Chills | Grade 3 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Paresthesia | Grade 4 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Hypertension | Grade 3 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Paresthesia | Did not experience this AE | 49 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Shingles | Grade 2 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Syncope | Grade 2 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Chills | Grade 4 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Syncope | Grade 3 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Shingles | Grade 3 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Syncope | Grade 4 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Fatigue | Grade 2 | 2 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Syncope | Did not experience this AE | 49 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Shingles | Grade 4 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Rash | Grade 2 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Allergic Reaction | Grade 2 | 3 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Rash | Grade 3 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Shingles | Did not experience this AE | 49 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Rash | Grade 4 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Hypertension | Grade 4 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Rash | Did not experience this AE | 49 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Sinusitis | Grade 2 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Skin Swelling | Grade 2 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Fatigue | Did not experience this AE | 47 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Skin Swelling | Grade 3 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Sinusitis | Grade 3 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Skin Swelling | Grade 4 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Increased ALT | Grade 2 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Skin Swelling | Did not experience this AE | 49 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Sinusitis | Grade 4 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Hot Flashes | Grade 2 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Hot Flashes | Grade 3 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Injection Site Reaction | Grade 2 | 2 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Hot Flashes | Grade 4 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Sinusitis | Did not experience this AE | 49 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Hot Flashes | Did not experience this AE | 49 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Allergic Reaction | Did not experience this AE | 46 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Hypertension | Grade 2 | 1 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Arthritis | Grade 2 | 2 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Injection Site Reaction | Grade 3 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Hypertension | Did not experience this AE | 48 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Arthritis | Grade 3 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Increased ALT | Grade 3 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Increased ALT | Grade 4 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Arthritis | Grade 4 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Increased ALT | Did not experience this AE | 49 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Injection Site Reaction | Grade 4 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Increased AST | Grade 3 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Chills | Did not experience this AE | 47 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Increased AST | Grade 4 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Arthritis | Did not experience this AE | 47 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Increased AST | Did not experience this AE | 49 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Injection Site Reaction | Did not experience this AE | 47 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Generalized Muscle Weakness | Grade 2 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Increased AST | Grade 2 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Decreased ANC | Grade 4 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Generalized Muscle Weakness | Grade 3 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Decreased ANC | Did not experience this AE | 49 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Nausea | Grade 2 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Decreased WBC | Grade 2 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Generalized Muscle Weakness | Grade 4 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Decreased WBC | Grade 3 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Decreased ANC | Grade 2 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Decreased WBC | Grade 4 | 0 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Generalized Muscle Weakness | Did not experience this AE | 49 Participants |
| GM-CSF Alone | Number and Severity of Observed Toxicities | Chills | Grade 2 | 2 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Decreased WBC | Did not experience this AE | 47 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Chills | Grade 2 | 1 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Chills | Grade 4 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Chills | Did not experience this AE | 47 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Fatigue | Grade 3 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Nausea | Did not experience this AE | 47 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Hot Flashes | Grade 2 | 1 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Hypertension | Grade 3 | 2 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Increased ALT | Grade 2 | 1 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Increased ALT | Did not experience this AE | 47 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Chills | Grade 3 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Fatigue | Grade 2 | 1 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Fatigue | Grade 4 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Fatigue | Did not experience this AE | 47 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Injection Site Reaction | Grade 2 | 2 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Injection Site Reaction | Grade 3 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Injection Site Reaction | Grade 4 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Injection Site Reaction | Did not experience this AE | 46 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Nausea | Grade 2 | 1 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Nausea | Grade 3 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Nausea | Grade 4 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Allergic Reaction | Grade 2 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Allergic Reaction | Grade 3 | 1 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Allergic Reaction | Grade 4 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Allergic Reaction | Did not experience this AE | 47 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Shingles | Grade 2 | 1 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Shingles | Grade 3 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Shingles | Grade 4 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Shingles | Did not experience this AE | 47 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Sinusitis | Grade 2 | 1 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Sinusitis | Grade 3 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Sinusitis | Grade 4 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Sinusitis | Did not experience this AE | 47 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Arthritis | Grade 2 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Arthritis | Grade 3 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Arthritis | Grade 4 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Headache | Did not experience this AE | 47 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Arthritis | Did not experience this AE | 48 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Generalized Muscle Weakness | Grade 2 | 1 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Generalized Muscle Weakness | Grade 3 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Generalized Muscle Weakness | Grade 4 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Generalized Muscle Weakness | Did not experience this AE | 47 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Myalgia | Grade 2 | 1 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Myalgia | Grade 3 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Myalgia | Grade 4 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Myalgia | Did not experience this AE | 47 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Headache | Grade 2 | 1 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Headache | Grade 3 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Headache | Grade 4 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Paresthesia | Grade 2 | 1 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Paresthesia | Grade 3 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Paresthesia | Grade 4 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Paresthesia | Did not experience this AE | 47 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Syncope | Grade 2 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Syncope | Grade 3 | 1 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Syncope | Grade 4 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Syncope | Did not experience this AE | 47 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Rash | Grade 2 | 1 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Rash | Grade 3 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Rash | Grade 4 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Rash | Did not experience this AE | 47 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Skin Swelling | Grade 2 | 1 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Skin Swelling | Grade 3 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Skin Swelling | Grade 4 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Skin Swelling | Did not experience this AE | 47 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Hot Flashes | Grade 3 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Hot Flashes | Grade 4 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Hot Flashes | Did not experience this AE | 47 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Hypertension | Grade 2 | 1 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Hypertension | Grade 4 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Hypertension | Did not experience this AE | 45 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Increased ALT | Grade 3 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Increased ALT | Grade 4 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Increased AST | Grade 2 | 1 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Increased AST | Grade 3 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Increased AST | Grade 4 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Increased AST | Did not experience this AE | 47 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Decreased ANC | Grade 2 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Decreased ANC | Grade 3 | 1 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Decreased ANC | Grade 4 | 1 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Decreased ANC | Did not experience this AE | 46 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Decreased WBC | Grade 2 | 1 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Decreased WBC | Grade 3 | 0 Participants |
| pTVG-HP Vaccine With GM-CSF | Number and Severity of Observed Toxicities | Decreased WBC | Grade 4 | 0 Participants |
Secondary
Prostate Specific Antigen (PSA) Doubling Time (DT)
PSA DT was calculated using all serum PSA values available from the same clinical laboratory for the specified period by the equation log2/b where b denotes the least-squares estimator of the linear regression model of the log-transformed PSA values on time. Pretreatment PSA DT (3-6 months before treatment, with a minimum of 4 values), on-treatment PSA DT was determined using values from month 3 to month 9.
Time frame: up to 9 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| GM-CSF Alone | Prostate Specific Antigen (PSA) Doubling Time (DT) | 8.9 months |
| pTVG-HP Vaccine With GM-CSF | Prostate Specific Antigen (PSA) Doubling Time (DT) | 5.4 months |
p-value: 0.08Wilcoxon Rank Sum test
Secondary
PSA Progression Free Survival
Time frame: up to 2 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| GM-CSF Alone | PSA Progression Free Survival | 9.0 months |
| pTVG-HP Vaccine With GM-CSF | PSA Progression Free Survival | 8.9 months |