Clinical trial NCT03315260: Treatment Satisfaction With Ra-223 in Japan
Official title: Treatment Satisfaction With Ra-223 Among Japanese Castration Resistant Prostate Cancer (CRPC) Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Neoplasms
Keywords: Castration resistant prostate cancer
Patient reported outcome
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-10-20
Enrollment: 85
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Japanese CRPC patients designated to receive Ra-223 (Xofigo)

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.

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.

Eligibility criteria: Inclusion Criteria:

* Age ≥20 years old (age of maturity in Japan)
* Male, diagnosed with CRPC
* With ≥2 bone metastases and no visceral metastasis based on the most recent imaging procedure
* 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 either in the 1st, 2nd, or 3rd line of CRPC therapy
* Has provided written, informed consent (in Japanese)
* Has ≥6 months life expectancy

Exclusion Criteria:

* Participation in an investigational program with interventions outside of routine clinical practice
* Currently receiving any chemotherapy for CRPC or any new hormone therapy (enzalutamide, abiraterone acetate) at enrolment
* Where any of the below conditions apply:

  * Started or switched to new androgen deprivation therapy (ADT) (e.g., LHRH agonists and antagonists, anti-androgens, estrogens,) 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 (AEs) (CTCAE Grade \>2) due to anticancer chemotherapy administered more than 4 weeks prior
  * Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within the previous 24 weeks
  * Previous hemi-body external radiotherapy
* Imminent or established spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI)
* Presence of other maligancy at enrolment
* Otherwise deemed incapable of participating by examining physician

Primary outcomes:
measure: Change in patient satisfaction with treatment using the Cancer Therapy Satisfaction Questionnaire (CTSQ)
timeFrame: From baseline to 7 months
Secondary outcomes:
measure: Change in the total scores of the CTSQ domains
timeFrame: From baseline to 7 months
measure: Change in patient anxiety with prostate cancer using the Memorial Anxiety Scale for Prostate Cancer (MAX-PC)
timeFrame: From baseline to 7 months
measure: Change in bone-related symptoms using the Functional Assessment of Cancer Therapy Quality of Life Measurement in Patients with Bone Pain (FACT-BP)
timeFrame: From baseline to 7 months
measure: Differences in change in treatment satisfaction (measured by CTSQ) between potential subgroups
timeFrame: From baseline to 7 months
measure: Differences in change in prostate cancer anxiety (measured by MAX-PC) between potential subgroups
timeFrame: From baseline to 7 months
measure: Differences in change in bone pain (measured by FACT-BP) between potential subgroups
timeFrame: From baseline to 7 months
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
facility: Many Locations
Study officials:
References:
citation: Akakura K, Uemura H, Kawakami S, Yokomizo A, Nakamura M, Nishimura K, Komori T, Ledesma DA. Metastatic castration resistant prostate cancer patients' experience with Radium-223 treatment in Japan. Future Oncol. 2024 Apr;20(12):781-798. doi: 10.2217/fon-2023-0870. Epub 2024 Jan 26.