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Treatment Satisfaction With Ra-223 in Japan

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ClinicalTrials.gov Identifier: NCT03315260
Recruitment Status : Not yet recruiting
First Posted : October 20, 2017
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
This study aims to answer the research question: Are Japanese bone metastatic CRPC patients satisfied with their Ra-223 treatment, and what factors drive such satisfaction? It also aims to determine patient anxiety regarding prostate cancer while on treatment with Ra-223, and assess the effect on quality of life.

Condition or disease Intervention/treatment
Prostatic Neoplasms Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

Detailed Description:
This is a local, Japanese, prospective, longitudinal, observational, company-sponsored, multi-center, single arm study that will describe treatment satisfaction with Ra-223 in 150 bone metastatic CRPC patients on 1st to 3rd line CRPC therapy. All outcomes will be obtained using PRO questionnaires at 4 time points: before treatment, during treatment, and at 1-month after the last treatment cycle.

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment Satisfaction With Ra-223 Among Japanese Castration Resistant Prostate Cancer (CRPC) Patients
Estimated Study Start Date : December 15, 2018
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
Bone metastatic CRPC patients
Japanese patients who are designated to undertake Ra-223/Xofigo therapy based on physician judgement
Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
Ra-223 is a radiopharmaceutical with an indication to treat Castration Resistant Prostate Cancer (approved indication in Japan)




Primary Outcome Measures :
  1. Change in patient satisfaction with treatment using the Cancer Therapy Satisfaction Questionnaire (CTSQ) [ Time Frame: From baseline to 7 months ]
    The CTSQ measures patient satisfaction in 3 domains:3 domains related to patients' satisfaction with cancer therapy: Expectations of Therapy (ET, 5 items), Feelings about Side Effects (FSE, 4 items) and Satisfaction with Therapy (SWT, 7 items). These 3 dimensions will be examined.


Secondary Outcome Measures :
  1. Change in the total scores of the CTSQ domains [ Time Frame: From baseline to 7 months ]
    Changes in the CTSQ scores as they are observed within the sample will be reported.

  2. Change in patient anxiety with prostate cancer using the Memorial Anxiety Scale for Prostate Cancer (MAX-PC) [ Time Frame: From baseline to 7 months ]
    Changes in the MAX-PC scores will be analyzed as full scores (no sub-domains).

  3. Change in bone-related symptoms using the Functional Assessment of Cancer Therapy Quality of Life Measurement in Patients with Bone Pain (FACT-BP) [ Time Frame: From baseline to 7 months ]
    Change in FACT-BP scores will be analyzed as full scores (no subdomains).

  4. Differences in change in treatment satisfaction (measured by CTSQ) between potential subgroups [ Time Frame: From baseline to 7 months ]
    Potential subgroups will be identified depending on the number of patients available for subgrouping. The same analysis points as above will be considered, but will be compared between two groups.

  5. Differences in change in prostate cancer anxiety (measured by MAX-PC) between potential subgroups [ Time Frame: From baseline to 7 months ]
    Potential subgroups will be identified depending on the number of patients available for subgrouping. The same analysis points as above will be considered, but will be compared between two groups.

  6. Differences in change in bone pain (measured by FACT-BP) between potential subgroups [ Time Frame: From baseline to 7 months ]
    Potential subgroups will be identified depending on the number of patients available for subgrouping. The same analysis points as above will be considered, but will be compared between two groups.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Japanese CRPC patients designated to receive Ra-223 (Xofigo)
Criteria

Inclusion Criteria:

  • Age ≥20 years old (age of maturity in Japan)
  • Male, diagnosed with CRPC
  • With ≥2 bone metastases and no visceral metastasis
  • Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 0-1, not in end-stage palliative care
  • Designated by examining physician to undergo Ra-223 treatment
  • Has provided written, informed consent (in Japanese)
  • Has ≥6 months life expectancy

Exclusion Criteria:

  • Participating in a clinical trial
  • Currently receiving any chemotherapy for CRPC at enrolment
  • Where any of the below conditions apply:

    • Started or switched to new androgen deprivation therapy (ADT) (e.g. Luteinizing Hormone-Releasing Hormone (LHRH) agonists and antagonists, anti-androgens, estrogens, abiraterone, enzalutamide, etc.) within 4 weeks prior to enrolment or planning to start new treatment prior to 1st Ra-223 injection
    • Treatment with anticancer-chemotherapy within previous 4 weeks, or planned before the 1st Ra-223 injection, or failure to recover from adverse events (CTCAE Grade >2) due to anticancer chemotherapy administered more than 4 weeks prior

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03315260


Contacts
Contact: Bayer Clinical Trials Contact (+) 1-888-8422937 clinical-trials-contact@bayer.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

Locations
Japan
Many Locations Not yet recruiting
Multiple Locations, Japan
Sponsors and Collaborators
Bayer

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03315260     History of Changes
Other Study ID Numbers: 19502
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
Castration resistant prostate cancer
Patient reported outcome

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Radium Ra 223 dichloride
Antineoplastic Agents