Localized prostate cancer after primary radical prostatectomy
Conditions
Sponsors
Sotio a.s.
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the PSA doubling time in patients in immunotherapy group and in the control group in the treatment phase of the study.;Secondary Objective: Other objectives are to compare the PSA doubling time measured in the treatment phase with the PSA doubling time prior to randomization in patients in both groups, to evaluate the PSA doubling time in patients in immunotherapy group and in the control group in the follow-up phase of the study, to monitor the incidence of adverse events, to determine the proportion of patients with a biochemical relapse, progressive increase in the PSA, objective disease progression or further anticancer therapy introduction within two years of randomization and to compare Overall Survival between the two groups. An exploratory objective is to search for potential biomarkers that could play a role as prognostic factors, indicate the biological effect of ACI on the immune-reponse or identify a subgroup of patients profiting from cancer immunotherapy.;Primary end point(s): The primary endpoint is the PSA doubling time in the treatment phase (from randomization to Visit V10 at Week 40).;Timepoint(s) of evaluation of this end point: N/A | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Comparing the PSA doubling time measured in the treatment phase with the PSA doubling time prior to randomization • Value of the PSA doubling time in the follow-up phase (from completed visit at Week 40 to 2 years from randomization) • Incidence of adverse events • The proportion of patients with objective disease progression (metastatic disease development -Distant Failure-DF) within 2 years of randomization • The proportion of patients who required any further anticancer therapy within 2 years of randomization • For the subgroup of patients who did not undergo salvage radiotherapy (only RPE), the proportion of patients who had a biochemical relapse within 2 years of randomization • The proportion of patients who had a progressive increase in the PSA within 2 years of randomization • Overall Survival Exploratory endpoints • Immune response • Gene expression profiling, and/or expression levels of a defined set of immune or cancer-related genes, respectively;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Czech Republic
Contacts
Public ContactClinical Trials Sotio
Sotio a.s.
Outcome results
None listed