Condition category
Cancer
Date applied
06/10/2016
Date assigned
10/10/2016
Last edited
10/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 Bizhan Romani

Trial website

Contact information

Type

Scientific

Primary contact

Dr Bizhan Romani

ORCID ID

http://orcid.org/0000-0003-1736-2051

Contact details

Ahvaz Jundishapur University of Medical Sciences
Ahvaz
61357-15794
Iran

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 measures

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

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

Sponsor information

Organisation

Ahvaz Jundishapur University of Medical Sciences

Sponsor details

Golestan Blv
Ahvaz
61357-15794
Iran

Sponsor type

University/education

Website

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 Bizhan Romani

Intention to publish date

14/10/2020

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes