Prostate Cancer
Conditions
Keywords
Prostatectomised cancer patients
Brief summary
The study will evaluate safety and immunological response to RhoC peptide vaccine in patients with prostate cancer
Interventions
BIOLOGICALRV001V
Sc injection
Sponsors
Dantrials Aps
RhoVac APS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients prostatectomised (PT) due to histologically verified adenocarcinoma of the prostate gland who currently are not being treated, or expected within the next 8 months to be treated, with any anti-cancer treatment. * ECOG performance status 0 or 1.
Exclusion criteria
* Patient has been treated with Androgen Deprivation Therapy (ADT), or expected to receive such treatment within the next 8 months from enrolment. * Severe medical conditions, such as but not limited to severe asthma/chronic obstructive pulmonary disease (COPD), New York Heart Association (NYHA) grading 3 or above, poorly regulated insulin dependent diabetes, any significant organ damage as judged by the Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportions of Participants With Treatment-related Adverse Events | 8 month | Proportions of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunological Response | 12 months | RV001-specific immunological response after treatment from baseline to each treatment and follow-up |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental: RV001V RV001 Vaccine 0.1 mg/mL (RV001V). RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51.
RV001V: Sc injection | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | Experimental: RV001V |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 17 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 67.6 years STANDARD_DEVIATION 6.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Region of Enrollment Denmark | 22 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 22 |
| other Total, other adverse events | 22 / 22 |
| serious Total, serious adverse events | 4 / 22 |
Outcome results
Primary
Proportions of Participants With Treatment-related Adverse Events
Proportions of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 8 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental: RV001V | Proportions of Participants With Treatment-related Adverse Events | 22 Participants |
Secondary
Immunological Response
RV001-specific immunological response after treatment from baseline to each treatment and follow-up
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental: RV001V | Immunological Response | 18 Participants |