Clinical trial NCT03305224: The Combination Therapy With Ra-223 and Enzalutamide
Official title: The Study of Combination Therapy With Radium-223 and Enzalutamide in Osaka City University
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Castration-resistant Prostate Cancer
Bone Metastases
Keywords: castration-resistant prostate cancer
bone metastasis
Lead sponsor: Osaka City University
Sponsor class: OTHER
Collaborators: name: Bayer Yakuhin, Ltd.
First posted: 2017-10-09
Enrollment: 10
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 Criteria:

1. Patients diagnosed as CRPC
2. Surgical or those who will be treated with luteinizing hormone-releasing hormone (LHRH) agonists throughout the study period,
3. Patients who had \>30% of PSA response to enzalutamide prior to enrollment,
4. Interval between PSA progression and enrollment is up to 3 months,
5. With bone metastases (≥ 2 hot spots) on bone scintigraphy within previous 24 weeks,
6. No intention to use anti-cancer chemotherapy within the next 6 months,
7. Eastern Cooperative Oncology Group performance status (ECOG-PS): 0-1,
8. Life expectancy ≥ 6 months,
9. 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,
10. Age ≥ 20,
11. Ability to understand and the willingness to sign a written informed consent (IC).

Exclusion Criteria:

1. Prior chemotherapy or planned treatment with chemotherapy,
2. PSA progression within 3 months after initiation of enzalutamide
3. Prior treatment with corticosteroids, estramustine or abiraterone acetate,
4. Any systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bone metastases,
5. Had history of gastrointestinal bleeding or ulcer within 3 months prior to study entry,
6. History of visceral metastasis, or presence of visceral metastasis detected by screening imaging examinations,
7. History of or known brain metastasis,
8. Malignant lymphadenopathy ≧1.5 cm in short axis,
9. Imminent or established spinal cord compression based on clinical findings and/or MRI (Magnetic Resonance Imaging),
10. Any other serious illness or medical condition
11. Substance abuse, medical, psychological, or social conditions that might interfere with the subject's participation in the study or evaluation of the study Results
12. Those who judged to be inappropriate by the principal investigator or co-investigator.

Primary outcomes:
measure: Changes in Alkaline phosphatase (ALP)
timeFrame: 6 months
Secondary outcomes:
measure: Tolerability of Radium-223 therapy
timeFrame: 6 months
measure: Evaluation for bone metastasis by 18F-NaF-PET
timeFrame: 1, 3, 6 months
measure: Evaluation for bone metastasis by bone scintigraphy
timeFrame: 1, 3, 6 months
measure: Overall Survival Rate
timeFrame: 3 years
measure: Time to occurrence of Symptomatic Skeletal-related Events (SSEs)
timeFrame: 1 year
measure: Time to occurrence of visceral metastasis
timeFrame: 1 year
measure: Time to initiation of cytotoxic chemotherapy
timeFrame: 1 year
measure: Changes in Prostate Specific Antigen (PSA)
timeFrame: 6 months
measure: Changes From Baseline for Brief Pain Inventory (BPI)
timeFrame: 6 months
measure: Changes From Baseline for Functional Assessment of Cancer Therapy - Prostate (FACT-P)
timeFrame: 6 months
measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
timeFrame: 6 months
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Osaka City University Graduate School of Medicine
Study officials:
References: