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Castration Resistant Prostate Cancer (CRPC)DELCNCT02669147

A Study to Determine Enzalutamide Long-term Safety and Efficacy After Anti-androgen Therapy for CRPC

An observational study of Castration Resistant Prostate Cancer (CRPC), run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a prospective observational study to evaluate effectiveness and safety of Enzalutamide for Castration Resistant Prostate Cancer (CRPC) patients who decided to administer Enzalutamide after anti-androgen therapy. Read more about this study

Who is it for?
Ages 20 years and older, men only
How many people
160 participants
Where
No sites listed yet
Study dates
26 Jan 2016to Mar 2021
Phase
Observational
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

Study population: CRPC patients who are observed PSA or disease progression after anti-androgen therapy and decided to administrate Enzalutamide

Who may be able to join

  • Patients with histologically or cytologically confirmed prostate cancer.
  • Patients who are receiving or received continuous androgen deprivation therapy using both gonadotropin-releasing hormone (GnRH) agonist and antagonist (medical castration), or both testicles removal by surgery (surgical castration).
  • Castration resistant prostate cancer (CRPC) patients who are observed disease progression after castration treatment and implied the treatment resistant.
  • CRPC patients who conducted anti-androgen alternating therapy as shown below 1) and are observed one or more of disease progression shown as below 2) during or after the therapy and decided to administer enzalutamide.
  • Note 1) anti-androgen alternating therapy is defined as the therapy of flutamide administration after bicalutamide.
  • Note 2) Disease progression criteria during or after anti-androgen alternating therapy
Show all 11Show fewer
  • ① PSA progression during or after anti-androgen alternating therapy: PSA increased more than 25% compare to the lowest test results after initial dose of anti-androgen alternating therapy (flutamide) and the increasing is more than 2ng/ml.
  • ②Confirmed disease progression of soft tissue lesion defined as RECIST v1.1.
  • ③Confirmed disease progression of bone lesion defined as 2 or more of new appearance of bone lesion on bone scintigraphy.
  • Patients with the Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Patients who have signed written informed consent to participate in this study

Who cannot join

  • Patients who is administering or have administration history of enzalutamide, abiraterone, docetaxel or cabazitaxel
  • Patients with history of seizure or predisposing disease of seizure
  • Patients with severe liver dysfunction
  • Patients with a previous history of hypersensitivity to any component of drugs which will be administered in this study
  • Patients who considered to be inappropriate for the study participation by the investigator

About this study

This is a prospective observational study to evaluate effectiveness and safety of Enzalutamide for Castration Resistant Prostate Cancer (CRPC) patients who decided to administer Enzalutamide after anti-androgen therapy.

CRPC Patients who are observed PSA or disease progression after anti-androgen therapy and decided to administrate Enzalutamide will dose the Enzalutamide 160 mg orally once daily and observed the practical treatment. Total research term is for 4 years, consists of 2-year case registration terms and 2-year observational terms.

What is being measured

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

  1. Overall survival (OS)

    OS is defined as time from date of initial dose until date of death from any cause. In the case of any new chemotherapy added or changed to another treatment to prostate cancer, the conducted date will be applied. When patient is no longer traceable, the final confirmed date as alive will be applied to OS.

    Measured: 50 months

Secondary outcomes (8)

  1. Prostate Specific Antigen-progression-free survival (PSA-PFS)

    Prostate specific antigen (PSA) progression-free survival is defined as time from date of initial dose until the date of first confirmed PSA progression (an increase in PSA of >= 25% and >= 2 ng/ml above the nadir after initial dose) or date of death from any cause, whichever comes first. In the case of any new chemotherapy added or changed to another treatment to prostate cancer, the conducted date will be applied.

    Measured: 50 months

  2. Progression-free survival (PFS)

    PFS is defined as time from date of initial dose until the date of first confirmed progression or date of death from any cause, whichever comes first. Progression is defined as followed:① A growth of primary lesion or appearance of neopathy by image diagnosis, aggravation of general condition・PS decrease or noticable weight loss which investigator assess as progression. ②Unmeasurable or difficult to measure lesion which newly appeared or investigator assess as obvious aggravation. ③ In the case of any new chemotherapy added or changed to another treatment to prostate cancer

    Measured: 50 months

  3. Time to Treatment Failure (TTTF)

    TTTF is defined as time from date of initial dose until the date of any new chemotherapy added or changed to another treatment to prostate cancer.

    Measured: 50 months

  4. Time-to-PSA-progression (TTPP)

    TTPP is defined as time from date of initial dose until the date of first confirmed PSA progression (an increase in PSA of >= 25% and >= 2 ng/ml above the nadir after initial dose). In the case of any new chemotherapy added or changed to another treatment to prostate cancer, the conducted date will be applied.

    Measured: 50 months

  5. PSA response rate

    PSA response rate is defined as ratio of patients who have an decrease in PSA of >= 50% above baseline since initial dose.

    Measured: 50 months

  6. Time to First Symptomatic Skeletal Events (TTFS)

    TTFS is defined as time from date of initial dose until the date of first confirmed skeletal-related event. In the case of any new chemotherapy added or changed to another treatment to prostate cancer, the conducted date will be applied. Symptomatic Skeletal Events (SSE) defined as followed: ・Operation of EBRT External Beam Radiation Therapy (EBRT) to mitigate skeletal events ・New appearance of symptomatic pathological fracture ・Appearance of spinal cord compression ・Orthopedic intervention related to tumor

    Measured: 50 months

  7. The state of administration

    The state of administration is assessed by Relative Dose Intensity (RDI). RDI is calculated by dosage and dosing period. RDI calculation formula =∑ (daily dosage ×dosing days) / (160mg ×total dosing number of days). ∑ means all total dose which adds up in different dosage. Total number of days mean treatment term of this trial.

    Measured: 2 years

  8. Safety assessment

    Safety assessment by the incidence and severity of adverse events as assessed by Japanese version of the Common Terminology Criteria for Adverse Events (CTCAE) version 4.00

    Measured: 50 months

Timeline

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

  1. First posted29 Jan 2016 (estimated)
  2. Study start26 Jan 2016
  3. Primary completionMar 2021
  4. Study completionMar 2021

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02669147
Sponsor's protocol ID
TRIGU1517
Other IDs
UMIN000019855
Acronym
DELC
Status last verified
Dec 2022
First submitted
27 Jan 2016
Last updated
28 Dec 2022
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Castration Resistant Prostate Cancer (CRPC), run by Translational Research Center for Medical Innovation, Kobe, Hyogo, 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 11 inclusion and 5 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: finished, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Overall survival (OS) (time frame: 50 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 NCT02669147.

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 28 Dec 2022.

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