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ProstAtak® Immunotherapy + Radiation for Prostate Cancer (PrTK03 Trial)
PrTK03 Trial Summary
This trial is testing whether adding ProstAtak immunotherapy to radiation therapy can improve outcomes for patients with localized prostate cancer at high or intermediate risk for the disease coming back.
PrTK03 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPrTK03 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PrTK03 Trial Design
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Who is running the clinical trial?
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- I am taking more than 10mg of prednisone daily or other drugs that weaken my immune system.I am scheduled for radiation therapy targeting only my prostate.My prostate cancer is at an intermediate risk level or has one high-risk feature.I have liver disease, such as cirrhosis or active hepatitis.My cancer has spread to lymph nodes or other parts of my body.I am scheduled for radiation therapy targeting my pelvic area.I can take care of myself and am up and about more than half of my waking hours.My cancer is not low risk, has more than one high risk factor, or is very advanced.I have had or am planning to have surgery to remove my testicles for cancer treatment.I have had prostate cancer treatment, but only TURP or short-term ADT.
- Group 1: ProstAtak®
- Group 2: Control
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the total number of enrollees for this research project?
"This study is not recruiting at the moment. It was first posted on September 1st, 2011 and has had its information updated as recently as September 29th, 2022. There are other options available though; 1359 studies for patients with prostate cancer and 14 for Aglatimagene besadenovec + valacyclovir are currently looking for participants."
Is this clinical trial accessible in different parts of the state?
"For this clinical trial, there are active recruiting sites in Myrtle Beach, Gig Harbor, Albuquerque, and 61 other locations."
Has this study been done before?
"Aglatimagene besadenovec + valacyclovir has been researched for over a decade. The first study was conducted in 2006 and involved 46 patients that were sponsored by Millennium Pharmaceuticals, Inc.. After the success of the initial trial, Phase 2 drug approval was received in 2006. As of now, there are 14 active trials being performed in 126 cities across 4 countries."
What are the risks associated with taking Aglatimagene besadenovec + valacyclovir?
"Aglatimagene besadenovec + valacyclovir is a Phase 3 trial drug, meaning that there is some efficacy data and multiple rounds of safety data. Consequently, we believe it to be safe and have given it a score of 3."
Could you please compare and contrast this clinical trial involving Aglatimagene besadenovec + valacyclovir to others that have been completed?
"Aglatimagene besadenovec + valacyclovir, which was first studied in 2006, has undergone 66 clinical trials. There are currently 14 studies recruiting patients across the United States of America, with a large concentration in Myrtle Beach, South carolina."
What indications has Aglatimagene besadenovec + valacyclovir shown to be effective for?
"Aglatimagene besadenovec + valacyclovir is an accepted treatment for genital herpes. This combination therapy can also help patients manage human immunodeficiency virus type 1 (hiv-1) infection, herpes labialis, and chickenpox."
Who else is applying?
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