Patients with prostate cancer presenting Neuro-Endocrine (NE) differentiation developing non metatstatic castrate resistant disease and eligible to second line hormone treatment with non steroidal anti androgens. MedDRA version: 9.1 Level: SOC Classification code 10029104
Conditions
Interventions
Trade Name: IPSTYL
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Lanreotide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-
Sponsors
IPSEN
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Age equal to or greater than 18. Histologically proven diagnosis of prostate cancer. Evidence of PSA progression despite castrate levels of testosterone ( 20 U/L for ELISA assay and > 100 ng/ml for IRMA assay). ECOG Performance Status 0-1 Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 14 days prior to the start of the study treatment: Hb > 9.0 g/dl, absolute neutrophil count (ANC) > 1.500/mm3, platelet count >100.000/ml, total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with radiological signs of metastatic disease. Patients who according to the investigator opinion are candidate to be treated immediately with chemotherapy (e.g. docetaxel). Patients previously treated with total androgen ablation. Patients eligible to steroidal anti androgens. Diastolic blood pressure >100 mm/Hg despite anti-hypertensive drugs. Clinically significant cardiovascular disease (e.g. cerebrovascular accidents, myocardial infarction, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication). Renal impairment (creatinine levels above NL).Severe Parkinson disease. Known history of atrophic gastritis. Known history of cholelithiasis. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma effectively treated. Previous or concomitant treatment with a somatostatin analogue. Patients with known allergy to any of the components of the study medication.Concomitant assumption of drugs able to interfere with CgA synthesis. Treatment with any investigational drug within 30 days prior to enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To compare safety between Arm A and Arm B. To compare PSA response and median times to PSA response between Arm A and Arm B. To compare PSA doubling median times between Arm A and Arm B. To compare median times to PSA progression and Overall Survival (OS defined as the time from randomisation to death due to any cause). To compare the reduction from baseline in CgA serum levels between Arm A and Arm B. To correlate the changes in serum CgA with PSA response.;Main Objective: To assess the efficacy in terms of Progression-free survival (PFS) of the administration of non steroidal anti androgens and LHRH-a (Arm A) versus lanreotide in addition to non steroidal anti androgens and LHRH-a (Arm B) as second line approach in non metastatic prostate cancer patients with castrate resistant disease and elevated CgA circulating levels. According to the updated guidelines of the PCWG2 Progression-free survival (PFS) will be considered a composite end point defined as the time from random assignment to disease progression in bone or soft-tissue, symptoms, or death.A rising PSA alone will not be considered an indicator of disease progression since radiographic or symptomatic progression better reflect changes in clinical status.Subjects stopping the study for any reason, including isolated PSA increase, will be censored at their last date of evaluation.Patients without tumor progression or death at the time of analysis will be censored at their last date of evaluation;Primary end point(s): To assess the efficacy in terms of PFS of the administration of non steroidal anti androgens and LHRH-a (Arm A) versus lanreotide in addition to non steroidal anti androgens and LHRH-a (Arm B) as second line approach in prostate cancer patient with castrate resistant disease and elevated CgA circulating levels. As per PCWG2 updated guidelines PFS will be considered a composite end point defined as the time from random assignment to disease progression in bone or soft-tis | — |
Countries
Italy
Outcome results
None listed