ProstAtak Immunotherapy for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+22 other locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Candel Therapeutics, Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing CAN-2409, a treatment that kills prostate cancer cells and boosts the immune system to fight the cancer. It targets patients with localized prostate cancer. The treatment aims to improve their health outcomes by helping their immune system attack the cancer.

Eligibility Criteria

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.

Inclusion Criteria

My cancer is not classified as high risk, very high risk, or metastatic.

My prostate cancer diagnosis was confirmed through a tissue examination.

I have chosen to monitor my condition without immediate treatment.

+7 more

Exclusion Criteria

My cancer has spread to lymph nodes or other parts of my body.

Known HIV+ patients

Other serious co-morbid illness or compromised organ function that, in the opinion of the investigator, would interfere with treatment or follow up

+8 more

Participant Groups

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.

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