NCT03305224

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2017

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 9, 2017

Completed
18 days until next milestone

Study Start

First participant enrolled

October 27, 2017

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

September 9, 2021

Status Verified

September 1, 2021

Enrollment Period

4 years

First QC Date

August 28, 2017

Last Update Submit

September 8, 2021

Conditions

Castration-resistant Prostate CancerBone Metastases

Keywords

castration-resistant prostate cancerbone metastasis

Outcome Measures

Primary Outcomes (1)

  • Changes in Alkaline phosphatase (ALP)

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

    6 months

Secondary Outcomes (11)

  • Tolerability of Radium-223 therapy

    6 months

  • Evaluation for bone metastasis by 18F-NaF-PET

    1, 3, 6 months

  • Evaluation for bone metastasis by bone scintigraphy

    1, 3, 6 months

  • Overall Survival Rate

    3 years

  • Time to occurrence of Symptomatic Skeletal-related Events (SSEs)

    1 year

  • +6 more secondary outcomes

Study Arms (1)

Ra-223 + Enzalutamide

OTHER
Drug: Ra-223 in combination with enzalutamide

Interventions

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

Ra-223 + Enzalutamide

Eligibility Criteria

Age20 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,
  • +2 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osaka City University Graduate School of Medicine

Osaka, 545-8585, Japan

Location

MeSH Terms

Interventions

Radium-223enzalutamide

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 28, 2017

First Posted

October 9, 2017

Study Start

October 27, 2017

Primary Completion

October 30, 2021

Study Completion

March 31, 2022

Last Updated

September 9, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)