metastatic prostate cancer castration resistant MedDRA version: 20.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10036909 Term: Prost
Conditions
Interventions
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: cis-diamina (1,1-ciclobutanodicarboxilato) platino
CAS Number: 41575-94-4
Sponsors
Centro Nacional de Investigaciones Oncológicas (CNIO)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Pre-screening Inclusion Criteria: • Signed prescreening informed consent form • Male =18 years old • Histologically, or cytologically, confirmed adenocarcinoma of the prostate • Evidence of metastatic CRPC amenable for tumors biopsies, with distant metastases documented by radionuclide bone scan, CT scan or MRI • Ongoing therapy with luteinizing hormone releasing hormone (LH-RH) analogue or bilateral orchiectomy with serum testosterone 1.5 x ULN, calculated creatinine clearance must be >30 ml/min (Gault and Cockroft method) • Subjects capable of maintaining sexual intercourse and therefore of fathering children, must agree to use an effective method of contraception for the duration of the trial and 6 months after last dose 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
Exclusion criteria
Exclusion criteria: Pre-screening Exclusion Criteria: • Prior treatment with PARP-inhibitors, except for those patients eligible for Cohort A Exclusion Criteria (screening): • Pre-screening exclusion criteria • Previous cancer diagnosis, except those patients who had a localized malignant tumor and who are five years cancer-free or those diagnosed with skin cancers (of non-melanoma type) or excised in situ or non-muscle invasive bladder cancer (NIMBC) who has had definitively curative treatment • Any prior medical history that according to the judgement of the investigator might interfere with the subject’s granting of informed consent or the safe execution of the procedures required in the study • Other serious illness(es) involving cardiac, respiratory, central nervous system, renal, hepatic or haematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study • Uncontrolled progressive thrombo-embolic disease or active uncontrolled infection • Grade > 1 peripheral neuropathy or any prior/concurrent toxicity which may interfere with the safety assessment or lead to premature carboplatin discontinuation • Known brain or leptomeningeal involvement unless clinically stable and on stable dose of steroids • Hypersensitivity to carboplatin or any compound containing platinum • Use of systemic chemotherapeutic (including but not limited to taxanes), hormonal, biologic, or radionuclide therapy for treatment of metastatic prostate cancer (other than approved bone-targeting agents and GnRH agonist/antagonist) or any other investigational agent within 4 weeks or 5 times drug median half-life if shorter before Day 1 • Subjects who have any previous treatment with DNA-damaging cytotoxic chemotherapy (ie, platinum-derivatives, mitoxantrone, cyclophosphamide), except if for non-prostate cancer indication and last dose > 5 years prior to randomization • Patients with previous =25 % bone marrow irradiation within the 4 weeks prior to planned start of treatment • Major surgery within 28 days prior to the first dose of Carboplatin • Known Hepatitis B surface antigen (HBsAg) or positive hepatitis C antibody or HIV • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the efficacy of single agent carboplatin, as measured by response rate, in three different cohorts of patients with progressive metastatic CRPC; Secondary Objective: -To evaluate the safety and tolerability of carboplatin in each patient cohort -To estimate the efficacy of carboplatin, as measured by time to prostate-specific antigen progression (TTPP) in each patient cohort -To estimate the efficacy of carboplatin, as measured by radiographic progression-free survival (rPFS) in each patient cohort -To estimate the efficacy of carboplatin, as measured by Clinical progression-free survival (cPFS) in each patient cohort -To estimate the efficacy of carboplatin, as measured by composite progression-free survival (compPFS) in each patient cohort -To estimate the effect on overall survival (OS) in each patient cohort ;Primary end point(s): Objective response rate (ORR), as defined as a composite of biochemical and/or objective radiographic responses according to PCWG3 and RECIST v1.1;Timepoint(s) of evaluation of this end point: every 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Number and grade of AEs according to the NCI-CTCAE v.5.0 -TTPP: median time and CI 95% to PSA progression according to PCWG3 -rPFS: median time and CI 95% to radiographic progression based on RECIST 1.1 and/or PCWG3 or death due to any cause, whichever occurs first -cPFS: median time and CI 95% to clinical progression based on the preestablished criteria for clinical progression or death due to any cause whichever occurs first -compPFS: median time and CI 95% to radiographic and/or clinical progression or death due to any cause, whichever occur first -OS: median time and CI 95% to death due to any cause ;Timepoint(s) of evaluation of this end point: Continuous reevlaution during the study | — |
Countries
Spain
Contacts
Public ContactProstate Cancer Unit
Centro Nacional de Investigaciones Oncológicas, CNIO
Outcome results
None listed