Prostate cancer, castration resistant prostate cancer, mCRPC, radium-223, biomarker, immune response. Prostaatkanker, castratieresistente prostaatkanker, radium-223, biomarker, immuunrespons.
Conditions
Interventions
Patients will be treated with radium-223 according to standard of care. Prior and during treatment, multi-parametric biomarkers will be collected. These biomarkers are obtained from blood samples, ima
Sponsors
Bayer
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Age = 18 years • Histologically confirmed, progressive prostate cancer during ADT. Castration-resistant disease is defined as a serum testosterone level of 50 ng per deciliter or lower (=1.7 nmol per liter) after bilateral orchiectomy or during maintenance treatment consisting of androgen-ablation therapy with a luteinizing hormone–releasing hormone agonist. • Baseline PSA level of = 2 ng per milliliter with evidence of progressively increasing PSA values (two consecutive increases over the previous reference value) • Prior treatment with at least two other approved agents for metastatic prostate cancer, unless the patient is not able and/or willing to receive other treatments. • Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1 (on a scale of 0 to 5, with 0 indicating no symptoms and full activity and higher scores indicating greater functional compromise) • Life expectancy of 6 months or longer • Adequate hematologic, renal, and liver function, including trombocytes >100x109/L, granulocytes >1.5x109/L, Hb >6.2 mmol/L.
Exclusion criteria
Exclusion criteria: • Prior chemotherapy, other than docetaxel. • Previous hemibody external radiotherapy or systemic radiotherapy with radioisotopes within the previous 24 weeks. • A blood transfusion or use of erythropoietin-stimulating agents within the previous 4 weeks • Pathological lymphadenopathy > 1.5 cm in the short-axis diameter on CT or MRI. [68Ga]-PSMA positive lymph nodes at baseline are allowed. • A history of presence of visceral metastases on CT or MRI. Patients with [68Ga]-PSMA positive lesions that are highly suspected for visceral metastases and are retrospectively visible on CT or MRI should be excluded as well. • Imminent or established spinal cord compression on CT or MRI. • A second active malignancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Exploratory analysis of multiple biomarkers in relation to failure-free survival, defined as time to next line of treatment, best supportive care or death. Next line of treatment or best supportive care will be started upon clinical, biochemical and/or radiological signs of progression according to the PCWG3 criteria. 2. Exploratory analysis of the immune response during radium-223 treatment in relation to failure-free survival as defined above. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Characterization of the mutational and immunological profile of pre-treatment tumor genome in relation to failure free survival as defined above. 2. Overall survival 3. Skeletal related events | — |
Contacts
Public ContactAnouk de Jong
Erasmus MC Rotterdam
Outcome results
None listed