Randomized, open-label, parallel group, multi-centre Phase II clinical trial of active cellular immunotherapy DCVAC/PCa in patients with localized prostate cancer after primary radical prostatectomy

Phase 1

• Conditions: ocalized prostate cancer after primary radical prostatectomy; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-004985-14-CZ
• Lead Sponsor: Sotio a.s.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-21
• Last Update Posted: 17 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Inc-1) Men aged = 18 years
Inc-2) Histologically confirmed pT2 stage prostate cancer
Inc-3) Post-radical prostatectomy (RPE) patients
Inc-4) PSA increase which is defined as follows:
Inc-4a) After salvage radiotherapy (or RPE, if patients did not undergo salvage radiotherapy), PSA level greater than 0.020 ng/mL was detected.
Inc-4b) PSA values measured after the value greater than 0.020 ng/mL resulted in PSA doubling time (PSADT) equal or less than 12 months (It is possible to use also the initial value greater than 0.020 ng/mL for PSADT calculation). PSADT must be based on at least three increasing values (i.e. each value greater than the previous one).The interval between two subsequent measurements should be3 months (however, intervals of at least 4 weeks and at most 6 months, i.e. 26 weeks, may be accepted).If PSADT is based on more than 3 values, all the values measured between the first and the last one must be taken into account (fluctuation is allowed but the resulting trend should be increasing and fulfil the condition PSADT =12 months).
Fulfilment of this inclusion criterion must be confirmed by the Sponsor before randomization of the patient.
Inc-5) Patients who meet one of the following criteria:
Inc-5a) Patients who did not undergo salvage radiotherapy, who had a PSA increase as defined in Inc-4) within 2 years of RPE.
Inc-5b) Patients after the salvage radiotherapy indicated at the PSA under 1.0 ng/mL, who had a PSA increase as defined in Inc-4) at any time interval from salvage radiotherapy.
Inc-6) The following laboratory values: WBC > 4 x 10(9)/L, platelet count > 100 x 10(9)/L, Hct>30%, creatinine under 1.5 times the upper normal limit, bilirubin, AST and ALT under two times the upper limit of normal.
Inc-7) ECOG 0-2 Performance Status
Inc-8) Signed informed consent to participate in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

Exclusion Criteria

E-1) Sexually active fertile men not using effective birth control, provided that their female partners are of fertile age and of child-bearing potential
E-2) Comorbidities of the patient
E-2a) HIV positivity
E-2b) Active hepatitis B or C
E-2c) Active bacterial, viral or fungal infection requiring systemic treatment
E-2d) Clinically significant cardiovascular disease,including myocardial infarction or ventricular tachyarrhythmia in previous 6 months, percutaneous coronary intervention or surgical revascularization within the previous 6 months, heart failure NYHA II-IV, known left ventricular dysfunction with ejection fraction < 40% or haemodynamically significant arrhythmias or conduction disorders, unless secured with permanent cardiac pacing.
E-2e) Pleural or pericardial effusion of any CTC grade
E-2f) Peripheral neuropathy CTC Grade = 2.
E-2g) Other uncontrolled intercurrent condition, uncompensated psychiatric illness or social situation that would limit patient’s compliance.
E-2h) Patients with a history of malignancy other than non-melanoma skin cancer.
E-2i) Unresolved clinically significant urinary tract obstruction
E-2j) Active autoimmune disease requiring treatment
E-2k) History of primary immunodeficiency
E-3) Allergies and adverse drug reactions
E-3a) History of allergic reaction to a compound of the same or similar structure as medication used in this study
E-3b) History of anaphylaxis or other severe reaction following vaccination
E-4) Any other serious reason the Investigator considers the patient should not participate in the study
E-5) Any prostate cancer N and M stage other than N0 and M0.
E-6) History of prostate cancer treatment using androgen deprivation therapy at any time in the past (pharmacological treatment or bilateral orchiectomy)
E-7) PSA > 1 ng/mL prior to starting salvage radiotherapy for biochemical relapse
E-8) History of or ongoing chemotherapy for prostate cancer
E-9) Participation in another clinical trial or administration of another investigational medicinal productwithin 30 days preceding the screening
E-10) Immunotherapy other than specified in this protocol
E-11) Unauthorized concomitant medication

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified