Neoadjuvant Study of the effect of Intratumoural and Intravenous Pexastimogene Devacirepvec (Pexa-Vec) on CD8-based anti-tumour response in Prostate Cancer Prior to Radical Prostatectomy

ACTRN 12620001286932

Brief Summary

The purpose of this study is to learn whether injecting Pexa-Vec directly into the prostate cancer or into the blood stream is a safe and useful treatment for patients with prostate cancer, before they undergo standard surgery to remove the prostate gland.

Intervention/Treatment

• Biological: Pexastimogene Devacirepvec (Pexa-Vec).

Inclusion Criteria

1. Patient has provided written informed consent.
2. Patients with histologically confirmed prostate adenocarcinomacancer arising from mucus-producing glands in organs.
3. Age greater than or equal to 18 years.
4. Suitable for radical prostatectomycomplete or partial removal of the prostate gland in the opinion of the treating surgeon, following results of all screening investigations, including PSMA PET/CT scan.
5. Disease detectable on MRI.
6. Patient has adequate organ function within 7 days prior to registration as defined as:
   • White blood cell count (WCC) greater than or equal to 2 x 109/L.
   • Absolute neutrophil count (ANC) greater than or equal to 1 x 109/L.
   • Haemoglobin greater than or equal to 90 g/L.
   • Platelet count greater than or equal to 100 x 109/L.
   • Activated partial thromboplastin time (aPTT) less than or equal to 1.5 ULN.
   • International Normalized Ratio (INR) less than or equal to 1.5 ULN.
   • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x ULN unless liver metastases are present, in which case it must be less than or equal to 5 x ULN.
   • Serum sodium 130-150mmol/L.
   • Serum potassium 3.0-5.5mmol/L.
   • Serum Corrected Calcium 2.0-2.9 mmol/L.
   • Serum Creatinine less than or equal to 1.5 ULN or estimated glomerular filtration rate greater than 30mL/min/1.73m2.
   • Oxygen saturation (SaO2) by pulse oximetry greater than 90% at rest.
7. For patients who are sexually active with partners of childbearing potential: willing to use double barrier contraception method for at least 6 weeks after each treatment of Pexa-Vec.
8. Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations during both the treatment and follow-up phases.