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Clinical Research

Evaluating Immunotherapy for Metastatic Prostate Cancer

A global clinical study evaluating an investigational vaccine-based immunotherapy (PROSTVAC- V/F + GM-CSF) for metastatic prostate cancer.

Our body’s immune system works hard to protect us from infection and disease every day of our lives. But for people with metastatic, castration-resistant prostate cancer, the immune system is simply not able to keep up with the demands forced on it – specifically, fighting back against cancer cells.

Now, scientists and researchers are looking at ways to improve the body’s response to metastatic prostate cancer through targeted immunotherapy, which is a way of stimulating the body’s immune system to specifically target cancer cells while leaving healthy cells unaffected.

This study evaluates the potential effectiveness of an investigational vaccine-based immunotherapy for metastatic prostate cancer. The investigational vaccine – administered through a series of injections over a period of five months – is designed to train the body’s immune system to identify and destroy prostate cancer cells.

The Investigational Product

The investigational vaccine regimen is delivered through a series of subcutaneous (under the skin) injections over a period of five months.

  • Some participants will receive injections of an investigational vaccine placebo (a substance that resembles the investigational vaccine, but is not designed to have the same effect).
  • Participants who receive the vaccine will receive injections of a granulocyte-macrophage colony stimulating factor (GM-CSF), which is a substance that helps to activate certain white blood cells involved in stimulating immune responses. Participants who receive the investigational vaccine placebo will be given the GM-CSF placebo (a saline-based solution).

The Study Regimens

If you are eligible to participate in this clinical research study you will be randomly assigned into one of three study regimens:

  • Study Regimen 1: The investigational vaccine and GM-CSF injections
  • Study Regimen 2: The investigational vaccine and GM-CSF placebo injections
  • Study Regimen 3: Investigational vaccine placebo and GM-CSF placebo injections

You will have a 2-in-3 chance of receiving the investigational vaccine. In order to ensure the effectiveness of the study, neither you nor your doctor will be informed of which study regimen you receive. However, the study doctor can find this out if they determine it to be necessary.

Retraining the body’s immune system

For this clinical research study, the immunotherapy involves a series of injections. Basically, the investigational vaccine is designed to stimulate the body’s immune system to target prostate cancer cells.

Ethics Committee Approval 

Clinical research studies such as the PROSTVAC study is an important part of the development of new medical treatments. They are designed to test investigational treatments so that regulatory agencies such as Food and Drug Administration, Ministries of Health, etc.) can determine whether these potential treatments are safe and effective for future use. To do this, the investigational treatment may be compared to current standards of care, placebos or to other forms of therapy.

Regulatory agencies have introduced strict and specific rules for conducting clinical research studies. For example, all clinical research studies must be approved and monitored by Ethics Committee (EC), whose role is to protect all participants in clinical research studies.  This study has been reviewed and approved by the Princess Alexandra Hospital Human Research Ethics Committee. All personal information provided by study participants is kept strictly confidential.

A Brief Summary of Study Participation

Participation in this study will include nine study visits over a period of approximately five months, with a Follow-Up Visit every six months until the end of the study.

Study participation is divided into three types of study visits:

  • Screening Visit
  • Treatment Visits
    • One priming vaccination
    • Six booster vaccinations
    • End-of-Treatment Visit
  • Follow-Up Visits

More information will be provided to eligible participants regarding the study visit regimens.

Eligibility to Participate

The PROSTVAC study is now enrolling participants to take part in this global research effort evaluating an investigational vaccine-based immunotherapy for metastatic prostate cancer.

You may be eligible to participate if you:

  • Have been diagnosed with metastatic, castration-resistant prostate cancer
  • Currently on Androgen Deprivation Treatment
  • Have never received chemotherapy
  • Are not currently taking a scheduled narcotic for cancer-related pain
  • Have received previous vaccination for smallpox

For Further Information or Appointments

Research staff contact numbers:

Dr Simon Wood (Principal Investigator) 07 3176 6946

Dr Irina Oleinikova (Study Coordinator) 07 3176 2217

Ms Linda Crook (Administration Support) 07 3176 3228

 

Recruitment finishes in December 2014.