Have you been diagnosed with early stage prostate cancer within the past 12 months?
Dendreon Pharmaceuticals LLC in collaboration with PRA Health Sciences is recruiting men ages 18 or older with newly diagnosed prostate cancer who are on active surveillance.
Sipuleucel-T (Provenge®) is a prescription medicine that is used to treat certain patients with advanced prostate cancer. Sipuleucel-T has been approved by the FDA for the treatment of metastatic castrate-resistant prostate cancer (cancer that has spread to other parts of your body). Dendreon Pharmaceuticals LLC is now looking at how this therapy works in men with newly diagnosed prostate cancer on active surveillance.
- Eligible participants will be randomized to receive sipuleucel-T treatments or continue on active surveillance.
– Participants in the sipuleucel-T group will receive 3 sipuleucel-T infusions and in-office follow-up visits every 6 months for a minimum of 3 years.
– Participants in the active surveillance group will continue on active surveillance and information will be collected at in-office follow up visits every 6 months for a minimum of 3 years.
- Individuals who have been recently diagnosed with prostate cancer and have had no former therapy for their prostate cancer may be eligible for participation.
What is the ProVent study?
The ProVent study is a randomized, open-label study designed to look at whether sipuleucel-T can slow the progression of prostate cancer for subjects in active surveillance, following sipuleucel-T therapy.
What is sipuleucel-T therapy?
Sipuleucel-T is a cellular immunotherapy that uses your body’s own immune cells to stimulate an immune response to target and fight your prostate cancer. Once your cells are collected, they will be sent to a manufacturing facility where they will be mixed with a protein that can stimulate your immune system to target prostate cancer cells. After processing, your cells will be re-injected into your vein.
Who can participate in the ProVent study?
You may be invited to join the ProVent study if you have been diagnosed with early stage, localized prostate cancer within the last 12 months and have not received any treatment for your prostate cancer, if you are age 18 or older, are currently on an Active Surveillance Protocol, and understand and sign an Informed Consent Form.
What is the Informed Consent form?
The Informed Consent Form describes the study and any risks. A member of your physician’s ProVent Study Team will answer any questions you may have. By signing the form, you agree to participate in the study.
Why should I join?
Your participation may help doctors and researchers determine if giving sipuleucel-T in early stage prostate cancer that has not spread outside of the prostate will delay the need for more therapy, affect your quality of life, and whether sipuleucel-T will cause any side effects such as fever or chills. This information may help doctors take care of patients with early stage prostate cancer in the future.
What will I be asked to do?
If you decide to participate in this study, you will be assigned to a treatment group or a control group. The treatment group will undergo sipuleucel-T therapy. The control group will not receive sipuleucel-T, but will remain on active surveillance. Your study doctor will monitor you for immune cell activation and any side effects.
You will also be asked to complete four questionnaires about your experience as a prostate cancer patient and how your treatment may affect your quality of life. Your information will be collected and used up to the point at which you decide to not participate.
You will be seen during a regularly scheduled clinic visit every 6 months for a minimum of 3 years, which is the same schedule you would follow if you were not enrolled in the study, although additional laboratory tests are required at these visits. On the same schedule as your standard active surveillance care, you will have 2 biopsies during the study.
Will my privacy be protected?
Your doctor and his/her staff will respect your privacy and keep your health information private to the extent permitted by law. Please also refer to the information contained in your Informed Consent Form about protecting your personal information.
Can I change my mind?
You will be asked to participate in the study for a minimum of 3 years, but you have the right to stop your participation at any time. If you sign up and later decide you do not want to continue, you may stop at any time. Simply tell your study doctor.
What if I have questions?
If you have questions about the study or your treatment at any time during the study, ask your study doctor.