Status:
ACTIVE_NOT_RECRUITING
Radium-223 Combined With Dexamethasone as First-line Therapy in Patients With M+CRPC
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Bayer
Conditions:
Metastatic Prostate Cancer
Eligibility:
MALE
Phase:
PHASE4
Brief Summary
More than 90% of patients with metastatic castration-resistant prostate cancer (mCRPC) no longer responding to androgen deprivation hormonal therapy have evidence of bone metastases. This is a major c...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Clinical diagnosis of prostate cancer
- ECOG status ≤ 2
- PSA ≥ 2.0 ng/mL
- 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
- Symptomatic disease defined as any analgesic use for pain or receipt of radiotherapy for bony metastatic disease
- 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
- Adequate hematologic function
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelet count ≥ 100 x 109/L
- Hemoglobin ≥ 100 g/L
- Evidence of bone metastasis on bone scan, CT, MRI or PET
- Life expectancy ≥ 6 months
- EXCLUSION CRITERIA:
- 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.
- Previous treatment with abiraterone, enzalutamide, docetaxel or other systemic chemotherapy for PCa
- Imminent spinal cord compression or history of spinal cord compression
- Previous treatment with systemic corticosteroids for PCa at any time
- Contraindication to receipt of systemic corticosteroids (i.e. uncontrolled diabetes)
- Prior or current enrolment in any other interventional clinical trial
Exclusion
Key Trial Info
Start Date :
February 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03432949
Start Date
February 23 2018
End Date
July 30 2024
Last Update
January 24 2024
Active Locations (1)
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1
University Health Network
Toronto, Ontario, Canada