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Cancer Vaccine

ProstAtak® Immunotherapy + Radiation for Prostate Cancer (PrTK03 Trial)

Phase 3
Waitlist Available
Research Sponsored by Candel Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Localized prostate cancer meeting the NCCN criteria of Intermediate Risk or patients having only one NCCN high-risk feature
Excluded are those in the following risk groups: Low risk; High risk with more than 1 high risk factor; Locally advanced/very high risk=T3b-T4; Metastatic: N1 or M1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at baseline and at 3, 6, 12, 18 and 24 months after completion of radiation.
Awards & highlights
Pivotal 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.

Who is the study for?
Men with intermediate-high risk localized prostate cancer, who have a good performance status (able to carry out daily activities), and meet specific criteria like PSA levels or Gleason score. They shouldn't have low-risk or high-risk factors beyond one, no regional lymph node involvement or distant metastases, no prior prostate cancer treatments except for certain types, and can't be on immunosuppressive drugs.Check my eligibility
What is being tested?
The trial is testing ProstAtak® Immunotherapy combined with standard radiation therapy against a placebo plus radiation. Participants are randomly assigned in a 2:1 ratio to either the treatment group or control group. The goal is to see if ProstAtak® improves outcomes by stimulating the immune system to fight cancer cells.See study design
What are the potential side effects?
ProstAtak®, when used with radiation therapy, has previously shown synergy without added toxicity; however, potential side effects may include typical reactions related to immunotherapies such as flu-like symptoms, fatigue, skin reactions at injection sites and possible mild fever.

PrTK03 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer is at an intermediate risk level or has one high-risk feature.
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My cancer is not low risk, has more than one high risk factor, or is very advanced.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My prostate cancer is at an intermediate risk level or has one high-risk feature.
Select...
My prostate cancer is intermediate risk with a PSA of 10-20, Gleason score of 7, or T2b-T2c.
Select...
My prostate cancer is high risk with either a PSA over 20, Gleason score 8-10, or T3a stage.
Select...
My cancer is not low risk, has multiple high risk factors, or is very advanced.
Select...
I am scheduled for radiation therapy targeting only my prostate.
Select...
I can take care of myself and am up and about more than half of the day.

PrTK03 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at baseline and at 3, 6, 12, 18 and 24 months after completion of radiation.
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline and at 3, 6, 12, 18 and 24 months after completion of radiation. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease free survival defined as the time from randomization until the date of the first failure event will be compared for the ProstAtak® arm versus the placebo control arm. The analyses will be based on the intent to treat population.
Secondary outcome measures
PSA nadir will be compared for the ProstAtak® arm versus the placebo control arm.
Patient reported Health Related Quality of Life outcomes will be collected using the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire. The change in QOL over time will be compared for the ProstAtak® arm versus the placebo control arm.
Prostate cancer specific survival and overall survival will be compared for the ProstAtak® arm versus the placebo control arm.
+1 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

PrTK03 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ProstAtak®Experimental Treatment1 Intervention
Aglatimagene besadenovec (CAN-2409) + valacyclovir + radiation therapy +/- ADT
Group II: ControlPlacebo Group1 Intervention
Placebo + valacyclovir + radiation therapy +/- ADT

Find a Location

Who is running the clinical trial?

Candel Therapeutics, Inc.Lead Sponsor
11 Previous Clinical Trials
562 Total Patients Enrolled
1 Trials studying Prostate Cancer
187 Patients Enrolled for Prostate Cancer

Media Library

ProstAtak® Immunotherapy (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT01436968 — Phase 3
Prostate Cancer Research Study Groups: ProstAtak®, Control
Prostate Cancer Clinical Trial 2023: ProstAtak® Immunotherapy Highlights & Side Effects. Trial Name: NCT01436968 — Phase 3
ProstAtak® Immunotherapy (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01436968 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
How old are they?
65+
What site did they apply to?
Southern Arizona VA Health Care System
What portion of applicants met pre-screening criteria?
Met criteria
~40 spots leftby Dec 2024