← Back to Search

Cancer Vaccine

ProstAtak Immunotherapy for Prostate Cancer

Phase 2
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
Excluded are those in the following risk groups: High risk with more than 1 high risk factor; Locally advanced/very high risk=T3b-T4; Metastatic: N1 or M1
Histologically confirmed adenocarcinoma of the prostate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to study completion, approximately 5 years
Awards & highlights

Study Summary

This trial is testing whether the immunotherapy drug ProstAtak can help patients with localized prostate cancer who are undergoing active surveillance.

Who is the study for?
Men with localized prostate cancer who choose active surveillance and meet certain risk criteria (low to intermediate, or one high-risk feature) can join. They must be able to undergo multiple injections into the prostate and have a performance status allowing daily activities. Excluded are those with advanced disease, other cancers, liver disease, HIV+, on immunosuppressants or planning radical treatment within a year.Check my eligibility
What is being tested?
The trial is testing CAN-2409 immunotherapy which uses aglatimagene besadenovec to kill tumor cells and stimulate an immune response against cancer. Participants will either receive this therapy or a placebo in addition to standard active surveillance for prostate cancer at a ratio of 2:1.See study design
What are the potential side effects?
CAN-2409 has been well tolerated in past trials but may cause reactions related to the immune system's activation such as flu-like symptoms, injection site pain, and potentially mild fever. The exact side effects in this trial will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is not classified as high risk, very high risk, or metastatic.
Select...
My prostate cancer diagnosis was confirmed through a tissue examination.
Select...
My prostate cancer is low risk with PSA under 10, Gleason score 6 or less, and is stage T1-T2a.
Select...
I can take care of myself and perform daily activities.
Select...
I am prepared and can safely undergo several prostate ultrasound injections.
Select...
I am prepared and can safely undergo several prostate ultrasound injections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to study completion, approximately 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to study completion, approximately 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
Negative biopsy rate at 1-year landmark
Percentage of patients with adverse events

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: CAN-2409Active Control2 Interventions
Patients randomized to the active arm will receive two courses of aglatimagene besadenovec (CAN-2409) + valacyclovir
Group II: PlaceboPlacebo Group2 Interventions
Patients randomized to the placebo arm will receive two corresponding courses of placebo + valacyclovir

Find a Location

Who is running the clinical trial?

Candel Therapeutics, Inc.Lead Sponsor
11 Previous Clinical Trials
1,086 Total Patients Enrolled
1 Trials studying Prostate Cancer
711 Patients Enrolled for Prostate Cancer

Media Library

Prostate Cancer Research Study Groups: CAN-2409, Placebo

Frequently Asked Questions

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

Is enrollment for this trial still open?

"This research, which was originally announced on May 1st 2016 and recently updated April 26th 2021, is no longer recruiting participants. Fortunately there are 1333 other studies that currently have open enrollment for volunteers."

Answered by AI

What are the principal applications of ProstAtak®?

"ProstAtak® is commonly employed to treat genital herpes, though it has also been found effective at managing HIV-1 infection, cold sores, and chickenpox."

Answered by AI

Is this research endeavor the inaugural venture of its type?

"ProstAtak® has been under the medical microscope since 2006, when Millennium Pharmaceuticals, Inc. launched its first trial with 46 patients. After Phase 2 approval was granted in that same year, 12 more studies have been initiated around the world across 123 cities and 4 countries."

Answered by AI

Is this clinical experiment being conducted at more than one spot in North America?

"22 different medical facilities are offering this trial, such as Lancaster Urology in Lancaster and the Ralph H. Johnson Veterans Affairs Medical Center in Charleston. Kansas City VA Medical Center is also participating along with another 19 sites across the country."

Answered by AI

How many individuals have been accepted to participate in this research?

"This clinical trial has finished recruitment, with its first post appearing on the 1st of May 2016 and last update occurring on April 26th 2021. If you are still seeking to participate in a study, 1321 studies for prostate cancer treatment and 12 trials involving ProstAtak® are currently recruiting patients."

Answered by AI

Has ProstAtak® been utilized in other experiments of a similar nature?

"Since 2006, ProstAtak® has been the subject of 2750 successful studies, with 12 trials currently underway. Most notably, Lancaster Pennsylvania is a primary site for this research."

Answered by AI

Has the FDA certified ProstAtak® for clinical use?

"Due to the lack of clinical data for efficacy, ProstAtak® was assessed as a 2 on our scale from 1-3 in terms of safety. This is because it has only completed Phase 2 trials."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Randomized Controlled Trial of CAN-2409 Immunotherapy During Active Surveillance for Prostate Cancer (ULYSSES)
2016. "Randomized Controlled Trial of CAN-2409 Immunotherapy During Active Surveillance for Prostate Cancer (ULYSSES)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02768363.
~13 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top