Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer

Summary

The purpose of this study is to evaluate the effectiveness of ProstAtak® immunotherapy in combination with radiation therapy for patients with intermediate-high risk localized prostate cancer. ProstAtak kills tumor cells and stimulates a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. ProstAtak has shown synergy with radiation without added toxicity and lower than expected recurrence rates in previous clinical trials. The hypothesis is that ProstAtak can lead to improvement in the clinical outcome for patients with prostate cancer. Participants will be randomized to the ProstAtak or control arm at a 2:1 ratio. Both arms receive standard external beam radiation therapy. Short-term androgen deprivation therapy may be given but is not required.

Timeline

Start

2011-09

Primary completion

2024-08

Completion

2030-12

Publications

• DeWeese TL, Manzanera A, Sylvester J, Wheeler T, Schroeder T, Gejerman G, Chesnut G, Facelle TM, Garzotto MG, Pieczonka C, Gandhi NM, Sukin S, Liss MA, Tutrone R, Mehlhaff B, Savage SJ, Goody M, Vogt J, Rao S, Polanco MLS, Barone F, Nichols WG, Tak PP; PrTK03 study team. Aglatimagene besadenovec (CAN-2409) with radiotherapy for patients with localised prostate cancer: a phase 3, multicentre, randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2026 Jun;27(6):673-685. doi: 10.1016/S1470-2045(26)00071-9.

Drugs

Indications