Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT03458559
Eligibility Criteria:
Inclusion Criteria:
* Male, 18 years or older
* Histologically confirmed prostate cancer
* Bone metastases (≥ 6 lesions) showing pathological uptake at bone scintigraphy.
* WHO performance status of ≤2
* Life expectancy of at least 6 months
* Castration-resistant disease: serum testosterone level of ≤ 1.7 nmol per liter (≤50 ng per deciliter) after bilateral orchiectomy or during maintenance treatment consisting of androgen-ablation therapy with a luteinizing hormone-releasing hormone agonist. During study treatment the maintenance androgen-deprivation therapy must be continued.
* Baseline PSA ≥5 ng/ml with evidence of progressively increasing PSA values
* Symptomatic disease with either regular use of analgesic medication or treatment with external-beam radiotherapy for cancer-related bone pain within the previous 12 weeks.
* Progression on or after treatment with docetaxel, or inability to receive docetaxel.
* Adequate renal function (serum creatinine level ≤1.5 x ULN)
* Adequate hematological function defined as absolute neutrophil count ≥ 1.5x10\^9/L and platelet count ≥100x 10\^9/L)
* Written informed consent
Exclusion Criteria:
* Treatment with chemotherapy within the previous 4 weeks
* Continuation of treatment with abiraterone or enzalutamide
* Previous hemibody external radiotherapy
* Systemic radiotherapy with radioisotopes within the previous 24 weeks
* Malignant lymphadenopathy ≥3cm in the short-axis diameter
* Presence of visceral metastases
* Imminent of established spinal cord compression
* Active uncontrolled bacterial, viral or fungal infection
* History of another malignancy within the last five years except adequately treated basal cell carcinoma of the skin
* Organ allografts requiring immunosuppressive therapy.
* Any serious uncontrolled concommitant disease
* 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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03458559
Study Brief:
Protocol Section:
NCT03458559