Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University Health Network, Toronto
With
Bayer
Age
Any age
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
1. Clinical diagnosis of prostate cancer
2. ECOG status ≤ 2
3. PSA ≥ 2.0 ng/mL
4. Rising PSA in combination with new metastases or evidence of radiographic disease progression despite castrate levels of testosterone while on androgen deprivation therapy (ADT) or following bilateral orchiectomy
5. Symptomatic disease defined as any analgesic use for pain or receipt of radiotherapy for bony metastatic disease
6. Adequate renal and hepatic function:
* Cr ≤ 1.5 x upper limit of normal (ULN)
* AST ≤ 2.5 x ULN
* ALT ≤ 2.5 x ULN
* Albumin \> 25 g/L
* Total bilirubin ≤ 1.5 x ULN
7. Adequate hematologic function
* Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
* Platelet count ≥ 100 x 109/L
* Hemoglobin ≥ 100 g/L
8. Evidence of bone metastasis on bone scan, CT, MRI or PET
9. Life expectancy ≥ 6 months
You may not be if
1. Visceral metastatic PCa (brain, liver, lung, bulky adenopathy). Note that metastatic lymphadenopathy \< 3cm is acceptable for inclusion as long as there is evidence of bone metastasis.
2. Previous treatment with abiraterone, enzalutamide, docetaxel or other systemic chemotherapy for PCa
3. Imminent spinal cord compression or history of spinal cord compression
4. Previous treatment with systemic corticosteroids for PCa at any time
5. Contraindication to receipt of systemic corticosteroids (i.e. uncontrolled diabetes)
6. Prior or current enrolment in any other interventional clinical trial
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