Clinical trial · Interventional
Study to Evaluate Zoledronic Acid on Quality of Life and Skeletal-related Events as Adjuvant Treatment in Patients With Hormone-naïve Prostate Cancer and Bone Metastasis Who Have Undergone Orchiectomy
Study to Evaluate Zoledronic Acid on Quality of Life and Skeletal-related Events as Adjuvant Treatment in Patients With Hormone-naïve Prostate Cancer and Bone Metastasis Who Have Undergone Orchiectomy.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
An open, multicenter and prospective study to evaluate the impact of the treatment with zoledronic acid 4 mg, on the quality of life and the skeletal-related events in patients with prostate cancer and bone metastasis that responds to hormonal therapy. Zoledronic acid is given to patients in a 15 minute-infusion every 4 weeks until a skeletal-related event occurs.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zoledronic acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Zoledronic Acid
- interventionNames
- Drug: Zoledronic acid
Primary outcomes (1)
- measure
- Evaluate the effects of Zometa® (Zoledronic Acid) i.v in doses of 4mg for measure the following parameters of efficacy: Quality of Life, Incidence of Events related to the skeleton
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 * histologically confirmed adenocarcinoma of the prostate. * Orchidectomy within the four previous weeks to enter the study. * bone metastasis evidenced by bone scan. * A hip DEXA study with a DS \< 3. * No hormonal therapy previous to enter the study. * ECOG performance score of 0-2. * Signed written informed consent. Exclusion Criteria: * Abnormal renal function evidenced by a creatinine clearance ≤60 ml/min. * Any kind of hormonal therapy for prostate cancer previous to enter the study. * Serum calcium corrected for albumin level \< 8.0 mg/dl. * WBC \< 3.0x10\^3, ANC \< 1500/mm3, Hemoglobin \< 8.0 g/dl, platelets \< 75 x 10\^3/l. * Abnormal hepatic function evidenced by ALT and AST value \>2.5 UNL * Subjects with any other malignant disease that can affect the bone. * Subjects with any other non malignant disease that can jeopardize the evaluation of the primary objectives of this trial (severe osteoporosis) or that do not aloud perform the trial evaluations. * Known hypersensibility to zoledronic acid or other bisphosphonates. * Subjects that in the investigator's opinion can not cooperate with the protocol. Other protocol inclusion/exclusion criteria may apply.
References
Publications (0)
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