Population enrolled in the study is represented by patients bearing advanced prostatic cancer with skeletal metastases and bone pain cancer-associated and treated with analgesic drugs MedDRA version: 14.1 Level: LLT Classification code 10005993 Term: Bone metastases System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: ZOMETA*IV 1FL 4MG+1F 5ML SOLV
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: ZOLEDRONIC ACID
CAS Number: 118072-93-8
Concentration unit: mg milligra
Sponsors
ISTITUTO NAZIONALE PER LA CURA TUMORI
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - patient bearing hormono-refractory prostatic cancer with aching skeletal localizations positive to bone scintigraphy; - patient in therapy with opioid but that hasn't an adequate control of the painful symptomatology during the last 24 hours; - signed informed consent; - life expectancy of at least 3 months; - Karnofsky Performance Status (KPS) > 50; - Hormonal treatment stable from 2 months at least; - No dental contraindication. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - Poor compliance to the protocol; - Inadequate medullar reserve; - Kidney failure; - Allergy to biphosphonates; - Medullar compression or epidural metastases; -Bone pain due to nervous pressure of nearby soft tissues by tumoral mass; - Chemotherapy or external radiotherapy within 6 weeks; -High risk of pathological fractures; - Contemporaneous treatment with aminoglycosides.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective is the comparison of the analgesic efficacy of the association zoledronic acid and 153Sm-lexidronam versus zoledronic acid for the treatment of bone pain associated to prostatic cancer.;Secondary Objective: Secondary objectives are: a) the performance of the two drugs in study by means of indicators that describe actions applied by the physician as variations of opioid dosage, switch of drugs, resort to rescue therapies, prescription of other analgesic drugs, interruption of the therapy or exit the protocol; b) incidence of correlates skeletal events; c) correlation between response and bone metabolism markers and PSA; d) safety and tolerability of the treatment observing adverse reactions to drugs, adverse events, adverse serious events and evaluating bone marrow adsorbed doses.;Primary end point(s): Primary endpoint is represented by patients ratio that will be classified as non-responders to the therapies in study;Timepoint(s) of evaluation of this end point: 60 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Evaluation of the first impact of the treatment in controlling bone pain; 2) Subject ratio that needed an increase of the opioid dosage >=5%; 3) Subject ratio that needed an additional treatment; 4) Subject ratio that needed adjuvant analgesic drugs; 5) Subject ratio that needed switch of opioid; 6) Subject ratio that exit protocol because of the treatment.;Timepoint(s) of evaluation of this end point: 1) 15 days 2-6) 60 days | — |
Countries
Italy
Contacts
Public ContactTerapia del dolore
Fondazione IRCCS Istituto Nazionale dei Tumori
Outcome results
None listed