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

Recruiting in Palo Alto (17 mi)

+73 other locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Candel Therapeutics, Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing ProstAtak® immunotherapy with radiation therapy for patients with intermediate-high risk localized prostate cancer. ProstAtak® kills cancer cells and helps the immune system learn to attack any remaining cancer cells, potentially improving treatment outcomes.

Eligibility Criteria

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.

Inclusion Criteria

I am scheduled for radiation therapy targeting only my prostate.

Exclusion Criteria

I am taking more than 10mg of prednisone daily or other drugs that weaken my immune system.

I have liver disease, such as cirrhosis or active hepatitis.

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

+5 more

Participant Groups

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.

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