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Castration-resistant Prostate CancerPhase 2CORE-OCUNCT03305224

The Combination Therapy With Ra-223 and Enzalutamide

A Phase 2 study testing Ra-223 in combination with enzalutamide in people with Castration-resistant Prostate Cancer and Bone Metastases, run by Taro Iguchi, MD, PHD at 1 site in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 20 years and older, men only
What is being tested?
Ra-223 in combination with enzalutamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteJapan
Study dates
27 Oct 2017to 31 Mar 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,
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  • 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).

Who cannot join

  • 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,
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  • 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.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Osaka City University Graduate School of Medicine

    Osaka, 545-8585

Other trials in Japan

About this study

Official title: The Study of Combination Therapy With Radium-223 and Enzalutamide in Osaka City University

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

Being tested
Ra-223 in combination with enzalutamide
Keywords
castration-resistant prostate cancer, bone metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ra-223 in combination with enzalutamideDrug

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

Study groups in NCT03305224
Study groupRoleWhat they receive
Ra-223 + EnzalutamideOtherNot described
Receives: Drug: Ra-223 in combination with enzalutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Alkaline phosphatase (ALP)

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

    Measured: 6 months

Secondary outcomes (11)

  1. Tolerability of Radium-223 therapy

    Proportion of patients who complete 6 times injections of radium-223

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: 1 year

  8. Changes in Prostate Specific Antigen (PSA)

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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2017
  2. Study start27 Oct 2017
  3. Primary completion30 Oct 2021 (estimated)
  4. Study completion31 Mar 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03305224
Sponsor's protocol ID
CORE-OCU
Acronym
CORE-OCU
Status last verified
Sep 2021
First submitted
28 Aug 2017
Last updated
9 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ra-223 in combination with enzalutamide in people with Castration-resistant Prostate Cancer and Bone Metastases, run by Taro Iguchi, MD, PHD at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Alkaline phosphatase (ALP) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03305224.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021; AzTrials last refreshed its copy on 1 Nov 2026.

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