ProstVac (rilimogene galvacirepvec)

P2, N=74, Completed, National Cancer Institute (NCI) | Trial completion date: Aug 2024 --> Dec 2023 | Active, not recruiting --> Completed

P1/2, N=24, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed

P2, N=33, Completed, Medical University of South Carolina | Active, not recruiting --> Completed

P2, N=29, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jan 2024 --> Jan 2025

P2, N=33, Active, not recruiting, Medical University of South Carolina | Trial completion date: Mar 2024 --> Jun 2024 | Trial primary completion date: Dec 2023 --> Mar 2024

P2, N=74, Active, not recruiting, National Cancer Institute (NCI) | Completed --> Active, not recruiting | Trial completion date: Jul 2022 --> Aug 2024

P2, N=33, Active, not recruiting, Medical University of South Carolina | Trial completion date: Sep 2023 --> Mar 2024 | Trial primary completion date: Sep 2023 --> Dec 2023

P1/2, N=20, Active, not recruiting, National Cancer Institute (NCI) | Trial primary completion date: Nov 2023 --> Jun 2023

P1/2, N=20, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting | N=29 --> 20

P2, N=74, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed

P2, N=29, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting

The combination of flutamide+PROSTVAC did not improve outcomes in men with nmCRPC compared with flutamide alone. (ClinicalTrials.gov Identifier: NCT00450463).

P2, N=154, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed | Trial completion date: Dec 2022 --> Jul 2022

In this first-of-kind trial of immunotherapy in patients on AS for prostate cancer, PROSTVAC did not elicit more favorable prostate tissue or peripheral T-cell responses than the EV. There was no difference between the arms in clinicopathologic effects. Despite the null findings, this is the first study reporting the feasibility and acceptability of an immunotherapy intervention in the AS setting.

P1/2, N=29, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Nov 2022 --> Nov 2023

P2, N=57, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed

P1/2, N=29, Recruiting, National Cancer Institute (NCI) | Trial completion date: Aug 2022 --> Dec 2022 | Trial primary completion date: Aug 2022 --> Nov 2022

P2 | "In this first-of-kind trial of immunotherapy for localized prostate cancer, PROSTVAC was well tolerated but did not elicit significant prostate tissue T-cell responses compared to placebo. The favorable post-treatment biopsy grade findings in PROSTVAC patients merit further evaluation and longer-term clinical follow-up."

P1/2, N=29, Recruiting, National Cancer Institute (NCI) | Trial primary completion date: Aug 2021 --> Aug 2022

Targeting DNA damage response (DDR) pathways in prostate cancer became a promising treatment strategy and olaparib and rucaparib, Poly(ADP-ribose) polymerase (PARP) inhibitors, have been approved for patients carrying mutations in homologous recombination (HR) repair pathways. In the field of immunotherapy, checkpoint inhibition as well as sipuleucel-T and PROSTVAC demonstrated only limited efficacy in mCRPC when used as monotherapy. This review discusses recent therapeutic strategies for mCRPC highlighting the need for rational combination of treatment options.

Enzalutamide and apalutamide treatment toggles renal 11β-HSD2 and significantly increases indicators of and exposure to biologically active glucocorticoids, which is associated with clinical outcomes.

Nevertheless, efforts are ongoing to help prime prostate tumors by turning a "cold" prostate cancer "hot" and thus rendering them more susceptible to immunotherapy. Combination treatments, use of molecular biomarkers, and use of new immunotherapeutic agents provide opportunities to enhance the immune response to prostate tumors.

Background PROSTVAC (P) is a therapeutic cancer vaccine targeting PSA...Funding: Bavarian Nordic. Clinical trial identification: NCT02649439.

Neoadjuvant PROSTVAC can induce both tumor immune response and peripheral immune response.

Whereas PROSTVAC was safe and well tolerated, it had no effect on OS or AWE in metastatic castration-resistant prostate cancer. Combination therapy is currently being explored in clinical trials.

Clinical trial information: NCT04020094. Research Funding: Bavarian-Nordic and Genetech/Roche.

Clinical trial information: NCT04020094. Research Funding: Bavarian-Nordic and Genetech/Roche.