Phase III Study in Metastatic Castration Resistant Prostate Cancer
Research type
Research Study
Full title
A Randomized, Double Blind, Placebo Controlled, Multicenter, Parallel-group Phase III study to evaluate efficacy and safety of DCVAC/PCa Plus Standard of Care Chemotherapy versus Placebo plus Standard of Care Chemotherapy in Men with Metastatic Castration Resistant Prostate Cancer.
IRAS ID
108971
Contact name
Hardev Pandha
Contact email
Sponsor organisation
SOTIO a.s
Eudract number
2012-002814-38
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
Prostate cancer (PCa) is the second most common cancer and the sixth leading cause of cancer death among men worldwide. PCa treatment options include prostatectomy, radiotherapy, hormonal treatment and chemotherapy. PCa can be cured at the stage of localized organ-confined disease, in which 10-year survival is 75- 93%. Patients with locally advanced or metastatic carcinoma have significantly poorer prognosis. Locally advanced disease is treated by a combination of surgery or radiotherapy with hormonal therapy. For patients with metastatic disease, androgen deprivation therapy (ADT) by orchiectomy or pharmacological agents is used. During hormonal therapy, disease progression occurs and castrate resistant disease develops (CRPC). DCVAC/PCa is an active autologous cellular immunotherapy (ACI) using autologous dendritic cells (DCs) produced ex-vivo from a patient’s monocytes which are pulsed with tumour cells killed by high hydrostatic pressure (HHP) and subsequently activated by a maturation agent. When the activated autologous DCs are infused back into the patient with CRPC an immune response is set up against the cancer which may inhibit progression and improve overall survival (OS).
Adult men (age ≥ 18 years) with histologically-confirmed prostate adenocarcinoma with clinical/ radiologic evidence of metastatic disease that has progressed despite ADT and can receive first line Standard of Care (SoC) chemotherapy (ie, docetaxel/prednisone), will be enrolled in this study. Following four weeks’ screening, all patients will have a leukapheresis procedure. A total of approximately 1170 patients will be randomized in a 2:1 ratio to receive either SoC chemotherapy with DCVAC/PCa or SoC chemotherapy with placebo. For those randomized to receive DCVAC/PCa, dendritic cells (DCs) obtained by leukapheresis will undergo ex-vivo manipulation (up to four weeks). All patients randomized to receive placebo injections will have a matched placebo prepared. The planned follow-up for each patient is 40 months and all patients will receive up to 15 injections.REC name
South Central - Oxford A Research Ethics Committee
REC reference
13/SC/0173
Date of REC Opinion
15 Jul 2013
REC opinion
Further Information Favourable Opinion