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Status unknownNCT03305224CORE-OCUUpdated Sep 9, 2021

The Combination Therapy With Ra-223 and Enzalutamide

A Phase 2 interventional study of Ra-223 in combination with enzalutamide in Castration-resistant Prostate Cancer and Bone Metastases, sponsored by Taro Iguchi, MD, PHD. Status unknown at 1 site in Japan. Open to male participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-09-09.

Sponsored by Taro Iguchi, MD, PHD · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
20 Years and older
Sex
Male
01

Study summary

This study is to evaluate preliminary efficacy of Ra-223 in combination with Enzalutamide in progressive CRPC patients with bone metastasis

02

Conditions studied

  • Castration-resistant Prostate Cancer
  • Bone Metastases

Keywords

  • castration-resistant prostate cancer
  • bone metastasis
03

Who can participate

Ages eligible
20 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Other
    Ra-223 + Enzalutamide

    Drug: Ra-223 in combination with enzalutamide

Interventions

  • DrugRa-223 in combination with enzalutamide

    Ra-223 (55 kBq/kg i.v.) 6 injections at 4 weeks interval in combination with enzalutamide 160 mg per a day

05

What researchers measure

Primary outcomes

  1. Changes in Alkaline phosphatase (ALP)

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

    Time frame: 6 months

Secondary outcomes

  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 18F-NaF-PET

    Fractional decline of intensity of tracer uptake measured by SUVmax on 18F-NaF-PET at 1, 3, 6 months.

    Time frame: 1, 3, 6 months

  3. Evaluation for bone metastasis by bone scintigraphy

    The change of Bone Scan Index (BSI) by bone scintigraphy at 1, 3, 6 months.

    Time frame: 1, 3, 6 months

  4. 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

  5. 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

  6. 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

  7. 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

  8. Changes in Prostate Specific Antigen (PSA)

    Percent change in prostate-specific antigen (PSA) from baseline at 6 months.

    Time frame: 6 months

  9. 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

  10. 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

  11. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

    Number of participants with adverse events as a measure of safety and tolerability.

    Time frame: 6 months

06

Study locations

1 site
  • Osaka City University Graduate School of Medicine
    Osaka, 545-8585, Japan
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03305224
Lead sponsor
Taro Iguchi, MD, PHD
Collaborators
Bayer Yakuhin, Ltd.
Responsible party
Taro Iguchi, MD, PHD (Principal Investigator, Osaka City University) — Sponsor-investigator
First posted
Oct 9, 2017
Start date
Oct 27, 2017
Primary completion
Oct 30, 2021 (estimated)
Completion
Mar 31, 2022 (estimated)
Last update
Sep 9, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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