Plain English Summary
Background and study aims
The prostate is a small gland in the pelvis found only in men. Prostate cancer is one of the most common cancers in men. Most cases of prostate cancer occur in patients over the age of 50 and currently there is no cure for it. The treatments mostly rely on chemotherapy to kill cancer cells, but they can cause unpleasant side effects. A vaccine has been developed to stimulate the patient's immune system to attack the cancer cells and shrink the tumour. The aims of this study are to see how safe the vaccine is, whether it can restrict the growth of prostate cancer tumours and also whether it can lead to an increase in patients’ life expectancy.
Who can participate?
Men aged 50-90 with prostate cancer
What does the study involve?
Participants are examined by a doctor a day before the first vaccination. Overall mental health, blood pressure, and pre-existing diseases are recorded and routine blood and urine tests are conducted. Participants are vaccinated five times with five different vaccine doses over 29 days. Weekly physical examinations and blood and urine tests are also conducted over the month. Afterwards, participants are monitored monthly for a total of 11 months. They are examined throughout the study to find out about any possible side effects of the vaccine. In addition, they are monitored to investigate any positive results from the treatment such as shrinkage of the tumor.
What are the possible benefits and risks of participating?
Participants are expected to have an immune response against the prostate tumor, which should decrease tumor growth and even shrink the tumor size. However, this vaccination could be accompanied with side effects that are generally seen with other types of vaccination. Pain, swelling and redness in the injection site are expected. Flu-like symptoms such as fever, muscle and joint pain, headache and fatigue could be experienced by the participants.
Where is the study run from?
1. Golestan Hospital (Iran)
2. Mehr Hospital (Iran)
3. Taleghani Hospital (Iran)
4. Arya Hospital (Iran)
When is the study starting and how long is it expected to run for?
October 2016 to October 2019
Who is funding the study?
Ministry of Health and Medical Education (Iran)
Who is the main contact?
Dr Elham Allahbahshi
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
U-86135
Study information
Scientific title
Evaluating the safety and tolerability of intravenous administration of an RNA-lipoplex cancer vaccine targeting three tumor-associated antigens in patients with prostate cancer
Acronym
Study hypothesis
Vaccination of prostate cancer patients with RNA-lipoplex for expression of PAP, PSMA, and STEAP1 inhibits the growth of prostate tumors and significantly enhances the life expectancy of the patients.
Ethics approval
Ethics committee of the Ahvaz Jundishapur University of Medical Sciences, 17/08/2016 , ref: EC20160712-3
Study design
Multicentre interventional study
Primary study design
Interventional
Secondary study design
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Prostate cancer
Intervention
Weekly (4-6 doses) intravenous administration of RNA-lipoplex for expression of three prostate cancer antigens (PAP, PSMA, STEAP1). RNA-lipoplex vaccine will be administrated intravenously. The patients will be vaccinated 5 times for the total of 29 days using the following doses:
Day 1: 7.5 ug RNA-lipoplex
Day 8: 15 ug RNA-lipoplex
Day 15: 30 ug RNA-lipoplex
Day 22: 30 ug RNA-lipoplex
Day 29: 30 ug RNA-lipoplex
The patients will be examined by a physician a day before the first vaccination. Overall mental health, blood pressure, and pre-existing diseases will be examined and recorded. Routine blood and urine tests will be conducted before the first vaccination. Weekly physical exams and blood and urine tests will be conducted for the total of 1 month. Afterwards, the patients will be monitored monthly for the total of 11 months.
Peripheral blood will be collected before vaccination and in week 1, week 2, week 3, week 4, month 2, month 3 of post-vaccination. Using the collected blood samples, specific T cell response and interferon production will be measured by ELISPOT. Using the same blood samples, specific antibody response and the total free PSA will also be measured by ELISA.
Intervention type
Biological/Vaccine
Phase
Drug names
Primary outcome measure
1. Number of adverse events as a measure of safety and tolerability over 90 days
2. Total number of adverse events over 90 days
3. Number of patients with adverse events over 90 days
Secondary outcome measures
1. Change of induced T-cell responses for RNA-Lipoplex vaccine from visit 2 (day 1) to day 90, assessed by immunoassays
2. Vaccine-induced T-cell responses in peripheral blood assessed by immunoassays before vaccination and in week 1, week 2, week 3, week 4, month 2, month 3 of post-vaccination
3. Vaccine-induced antibody responses in peripheral blood assessed by immunoassays before vaccination and in week 1, week 2, week 3, week 4, month 2, month 3 of post-vaccination
4. Change in serum PSA (prostate specific antigen) assessed by immunoassays before vaccination and in week 1, week 2, week 3, week 4, month 2, month 3 of post-vaccination
5. Change in the size of tumor. Patients' tumors will be scanned using MRI and PET/CT before the vaccination and after 3 months. This may be repeated for certain patients after 1 year, depending on the response to the treatment.
Overall trial start date
15/10/2016
Overall trial end date
14/10/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male patients with prostate cancer
2. Age 50-90 years old
Participant type
Patient
Age group
Mixed
Gender
Male
Target number of participants
30
Participant exclusion criteria
Unconfirmed cases of prostate cancer
Recruitment start date
15/10/2016
Recruitment end date
14/10/2018
Locations
Countries of recruitment
Iran
Trial participating centre
Golestan Hospital
Ahwaz
Khuzestan
61357-15794
Iran
Trial participating centre
Mehr Hospital
Tehran Province
District 6
W Zartosht St
Tehran
61357-15794
Iran
Trial participating centre
Taleghani Hospital
Tabnak St
Velenjak Region
Chamran High Way
Tehran
61357-15794
Iran
Trial participating centre
Arya Hospital
Keshavarz Blvd
Vesal Shirazi St. 10000
Tehran
61357-15794
Iran
Funders
Funder type
Government
Funder name
Ministry of Health and Medical Education
Alternative name(s)
MOHME
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Iran
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
IPD sharing plan
The datasets generated during and/or analysed during the current study will be available upon request from Dr Elham Allahbahshi
Intention to publish date
14/10/2020
Participant level data
Available on request
Basic results (scientific)
Publication list