Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Histologically or cytologically confirmed adenocarcinoma of the prostate at any given point in time during disease history
CRPC (castration-resistant prostate cancer) with clinical or radiologically confirmed bone progression
Treatment with 6 injections of radium-223 dichloride 50 kBq/kg and no evidence of progression to bone (according to Prostate Cancer Clinical Trials Working Group 2 \[PCWG2\] criteria) during the first course of treatment
Signed written informed consent prior to participating in any study related procedures. Willing and able to comply with the protocol, including follow-up visits and examinations
You may not be if
History of a radium-223 dichloride-related serious adverse event (SAE) or CTCAE Grade 3 or 4 adverse event (AE) during or after the initial course of radium-223 dichloride treatment that led to the discontinuation of treatment
Less than 30 days from the last dose administered in the initial course of radium-223 dichloride treatment
Visceral metastases 1 cm or greater in largest diameter and / or requiring local or systemic therapeutic intervention, as assessed by abdominal and pelvic magnetic resonance imaging (MRI) / computed tomography (CT) scan and / or chest X-ray within 30 days of the start of treatment
Lymphadenopathy with lymph nodes exceeding 6 cm in short-axis diameter and / or requiring local or systemic therapeutic intervention. Enlarged lymph nodes of any size if the lymphadenopathy is thought to be a contributor to concurrent hydronephrosis.
Current central nervous system (CNS) metastases
Chronic conditions associated with non-malignant abnormal bone growth (e.g., confirmed Paget's disease of bone)
Treatment with chemotherapy after the initial course of radium-223 dichloride treatment
Prior hemibody external radiotherapy
Prior systemic radiotherapy with strontium-89, samarium-153, rhenium-186, or rhenium-188
Any other serious illness or medical conditions
* Crohn's disease or ulcerative colitis
* History of documented bone marrow dysplasia
* Unmanageable fecal incontinence
Imminent or established spinal cord compression based on clinical findings and / or MRI that has not yet been treated
Other malignancy treated within the last 3 years (except non-melanoma skin cancer or low-grade superficial bladder cancer)
