None listed
Conditions
Interventions
Group 1 Type of group
8 mg of intravenous Zoledronate will be administered every 4 weeks until the development of bone metastasis.
Group name:Group 2 Type of group
They will receive placebo until the development of bone metastasis.
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Men over 18 years old, with Karnofsky´s performance status> 90. • Patients with asymptomatic prostate cancer, who previously received local curative treatment or those with advanced local disease who received LHRH agonist therapy and had no curative treatment. • Patients currently receiving first-line hormone therapy (LHRH agonists or surgical castration) and failed only at increasing levels of serum PSA. If LHRH agonists were used to treat patients instead of surgical castration, LHRH agonists should be maintained throughout the course of the study. • Biochemical progression documented by three consecutive ascending determinations of serum PSA, separated from each other for at least 2 weeks, the last determination being 50% or greater than the lowest PSA determination reached after the last therapeutic maneuver. (The first hormonal line mentioned above). • Serum PSA (value increased by 50%) above 4 ng / ml for patients with intact prostate and> 0.8 ng / ml after prostectoctomy on admission to the study. • Immediate history of increasing serum PSA values ​​ six months. • Have signed the informed consent prior to the initiation of any study procedure.
Exclusion criteria
Exclusion criteria: • Previous chemotherapy or other systemic antineoplastic therapy except LHRH antagonists, and / or non-asteroid anti-androgens • Palliative radiotherapy less than 6 weeks prior to the planned admission date. • Patients with known bone or visceral metastases. • Use of other experimental medications within the past 28 days. • WBC 2.5 ULN, serum creatinine> 1.5 ULN. • Presence of commitment of the SNC or leptomeninginal. • Another malignancy that may confuse the etiology of metastatic disease within 5 years prior to study entry, curative treatment for melanotic skin cancer. • Patients with other non-neoplastic diseases that could confuse the evaluation of the primary objectives or prevent the patient from complying with the protocol. • History of non-compliance with medical regimens.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The variable of primary efficacy is the free survival of bone metastases at the time of observation of the second analysis. The free survival of bone metastasis is defined as the time to the development of the documented bone metastasis. The evaluation for a patient with bone metastasis will be determined by scintigraphy. Measure:Primary Efficacy Timepoints:For the detection of bone metastasis, scintigraphy will be performed at 16-week intervals. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:1. Free survival of bone metastasis at the time of the third analysis. 2. Proportion of patients who develop bone metastasis within 2 and 4 years of the study. 3. Time to the first related skeleton event (EER) at the time of the third analysis. 4. Skeletal morbidity rate at the time of the third analysis. 5. Global survival at the time of the third analysis. 6. Evolution of the serum BSP Measure:Secondary Efficacy Timepoints:The duration of the study ; Outcome name:Monitoring and recording of all adverse events and adverse events of immediate reporting, regular monitoring of blood chemistry and performing physical exams. Measure:Safety Timepoints:The duration of the study | — |
Outcome results
None listed