Response measurement study in metastatic castration-resistant prostate cancer patients, treated with radium-223, to improve early response evaluation and understand the radium-223 induced immune response.
- Conditions
- Metastatic castration resistant prostate cancermetastatic prostate cancer10038588
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
- Histologically confirmed, progressive prostate cancer during ADT.
- Prior treatment with at least two other approved agents for metastatic
prostate cancer, unless the patient can*t or doesn*t want to receive other
treatments.
- Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.
- Life expectancy of 6 months or longer
- Adequate hematologic, renal, and liver function.
- 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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method