dm+d

Unassigned

New Medicines

ProstAtakIntermediate-high risk, localised, newly diagnosed prostate cancer - adjuvant to radiation therapy, with or without androgen deprivation therapy

Information

ProstAtak
New molecular entity
Advantagene
Advantagene

Development and Regulatory status

None
None
Phase III Clinical Trials
Nov 20ProstAtak has received fast track status from the US FDA for the treatment of prostate cancer [8].

Category

Thymidine kinase stimulant gene therapy that involves the local delivery of an adenoviral vector (Adv) with the Herpes thymidine kinase gene (HSV-tk) in combination with radiation therapy, along with an oral anti-herpetic prodrug (valacyclovir)
The age-standardised incidence of prostate cancer in the UK in 2014 was 175 per 100,000 population [4].
Intermediate-high risk, localised, newly diagnosed prostate cancer - adjuvant to radiation therapy, with or without androgen deprivation therapy
Intratumoural

Trial or other data

Nov 20PIII PrTK03 study (NCT01436968) continues to recruit in the US and Puerto Rico; collection of primary outcome data (disease-free survival) now expect to finish in Jun 23 [7].
Dec 19PIII study (NCT01436968) continues to recruit; collection of primary outcome data now due to complete Dec 22 [6]
Dec 19NCT01436968 - no UK sites [6]
Dec 18PIII study (NCT01436968) continues to recruit; collection of primary outcome data now due to complete Dec 21 [5].
Dec 17The PIII NCT01436968 study is still recruiting. The estimated primary completion date is now Dec 20 [3].
Mar 15Estimate final data collection date for trial Sept 2017 [2]
Apr 11US FDA has agreed on a Special Protocol Assessment (SPA) for a pivotal Phase III trial of ProstAtak for patients with newly diagnosed prostate cancer. The study is expected to enrol 711 patients starting mid-2011 with definitive results expected by 2015. The randomised study will assess ProstAtak´s ability to prevent prostate cancer recurrence..[1]