Prostate cancer
Conditions
Interventions
Product Name: RV001 Vaccine 0.1 mg/mL
Product Code: RV001V
Pharmaceutical Form: Emulsion for injection
INN or Proposed INN: Onilcamotide
CAS Number: 1164096-85-8
Current Sponsor code: RV001V
Other des
Sponsors
RhoVac ApS
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Patients who previously participated in RhoVac-001 study. 2) Patients who have provided written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 3 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 19
Exclusion criteria
Exclusion criteria: 3) Health conditions which in the opinion of the investigator will preclude the patient from participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if an long-term immunological response exists to vaccinations given to patients who previously participatied in the RhoVac-001 study ;Secondary Objective: To correlate levels in prostate-specific antigen (PSA) to any long-term immunological response;Primary end point(s): Immunological response;Timepoint(s) of evaluation of this end point: At enrolment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PSA level;Timepoint(s) of evaluation of this end point: At enrolment. | — |
Countries
Denmark
Contacts
Public ContactStudy Coordinator
DanTrials ApS
Outcome results
None listed