CORE-OCU study

JRCT ID: jRCTs051180124

Registered date:13/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Castration-resistant Prostate Cancer
• Date of first enrollment: 10/11/2017
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Ra-223 (55 kBq/kg i.v.) 6 injections at 4 weeks interval in combination with enzalutamide.

Outcome(s)

• Primary Outcome: Percentage of change from baseline to 6 months (or earlier for those who discontinue study therapy)

Secondary Outcome

1.Tolerability of Radium-223 therapy.Proportion of patients who complete 6 times injections of radium-223[Time Frame: 6 months]
2. Evaluation for bone metastasis by bone scintigraphy.Fractional decline of intensity of tracer uptake measured by GI-BONE on bone scintigraphy.
[Time Frame: 1, 3, 6 months]
3. Overall Survival Rate
Overall Survival (OS) is defined as the time from the registration to death due to any cause, or censored at date last
known alive.
[Time Frame: 3 years]
4. Time to occurrence of Symptomatic Skeletal-related Events (SSEs)
Time to occurrence of SSEs are defined asthe time from registration to the date of the occurrence of SSEs
(symptomatic fracture, surgery or radiation to bone, or spinal cord compression).
[Time Frame: 1 year]
5. Time to occurrence of visceral metastasis
Time to occurrence of visceral metastasis was defined as the time from registration to the date of the occurrence of a
visceral metastasis for each patient.
[Time Frame: 1 year]
6. Time to initiation of cytotoxic chemotherapy
The time to initiation of cytotoxic chemotherapy is defined as the time from registration to the date of initiation of
cytotoxic chemotherapy.
[Time Frame: 1 year]
7. Changes in Prostate Specific Antigen (PSA)
Percent change in prostate-specific antigen (PSA) from baseline at 6 months.
[Time Frame: 6 months]
8. Changes From Baseline for Brief Pain Inventory (BPI)
The change for the BPI-SF (Brief Pain Inventory-Short Form) score was calculated.
[Time Frame: 6 months]
9. Changes From Baseline for Functional Assessment of Cancer Therapy - Prostate (FACT-P)
The change for the FACT-P TOI domain (physical and social well-being and prostate specific score) was calculated.
[Time Frame: 6 months]
10. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)(fracture)
Number of participants with adverse events as a measure of safety and tolerability.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Male

Include 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 6 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).

Exclude 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 coinvestigator.

Related Information

• Primary Sponsor: Kato Minoru
• Source(s) of Monetary Support: Bayer Yakuhin, Ltd.
• Secondary ID(s): NCT03305224