Status:
UNKNOWN
The Combination Therapy With Ra-223 and Enzalutamide
Lead Sponsor:
Taro Iguchi, MD, PHD
Collaborating Sponsors:
Bayer Yakuhin, Ltd.
Conditions:
Castration-resistant Prostate Cancer
Bone Metastases
Eligibility:
MALE
20+ years
Phase:
PHASE2
Brief Summary
This study is to evaluate preliminary efficacy of Ra-223 in combination with Enzalutamide in progressive CRPC patients with bone metastasis
Eligibility Criteria
Inclusion
- Patients diagnosed as CRPC
- Surgical or those who will be treated with luteinizing hormone-releasing hormone (LHRH) agonists throughout the study period,
- Patients who had \>30% of PSA response to enzalutamide prior to enrollment,
- Interval between PSA progression and enrollment is up to 3 months,
- With bone metastases (≥ 2 hot spots) on bone scintigraphy within previous 24 weeks,
- No intention to use anti-cancer chemotherapy within the next 6 months,
- Eastern Cooperative Oncology Group performance status (ECOG-PS): 0-1,
- Life expectancy ≥ 6 months,
- Laboratory requirements within 30 days before enrollment:
- Absolute neutrophil count (ANC) ≥ 1.5 x 10e9/L,
- Platelet count ≥ 100 x 10e9/L,
- Hemoglobin ≥ 10.0 g/dL,
- Total bilirubin level ≤1.5 institutional upper limit of normal (ULN),
- Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 ULN,
- Creatinine ≤ 1.5ULN, and estimated glomerular filtration rate (GFR) ≥ 30 mL/min/1.73 m2,
- Age ≥ 20,
- Ability to understand and the willingness to sign a written informed consent (IC).
Exclusion
- Prior chemotherapy or planned treatment with chemotherapy,
- PSA progression within 3 months after initiation of enzalutamide
- Prior treatment with corticosteroids, estramustine or abiraterone acetate,
- Any systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bone metastases,
- Had history of gastrointestinal bleeding or ulcer within 3 months prior to study entry,
- History of visceral metastasis, or presence of visceral metastasis detected by screening imaging examinations,
- History of or known brain metastasis,
- Malignant lymphadenopathy ≧1.5 cm in short axis,
- Imminent or established spinal cord compression based on clinical findings and/or MRI (Magnetic Resonance Imaging),
- Any other serious illness or medical condition
- Substance abuse, medical, psychological, or social conditions that might interfere with the subject's participation in the study or evaluation of the study Results
- Those who judged to be inappropriate by the principal investigator or co-investigator.
Key Trial Info
Start Date :
October 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03305224
Start Date
October 27 2017
End Date
March 31 2022
Last Update
September 9 2021
Active Locations (1)
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1
Osaka City University Graduate School of Medicine
Osaka, Japan, 545-8585