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Prostate CancerJCASTRE-ZeroNCT02588001

Japanese Research for Patients With Non-metastatic Castration Resistant Prostate Cancer - Enzalutamide

A study testing Enzalutamide in people with Prostate Cancer, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 4 sites in 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

The purpose of this study is to investigate the efficacy and safety of enzalutamide in patients with non-metastatic castration resistant prostate cancer. The total duration of the study will be 5 years. All patients will receive enzalutamide 160 mg (four 40 mg capsules) orally once daily. Read more about this study

Who is it for?
Ages 20 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Enzalutamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
4 sitesJapan
Study dates
1 Oct 2015to 31 Mar 2021
Phase
Interventional
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 with histologically or cytologically confirmed prostate cancer
  • Patients with history of radical prostatectomy or radiation therapy for radical treatment
  • Patients who receive continuous androgen deprivation therapy using both gonadotropin-releasing hormone (GnRH) agonist and antagonist, or using surgical castration
  • Patients with serum testosterone 1.73 nmol/L (0.50 ng/dL) or less
  • Patients with history of bicalutamide or flutamide at any time after first recurrence confirmed since radical treatment completed
  • Patients with 3 increased PSA test results which measured consecutively at least one week apart during androgen deprivation therapy
Show all 12Show fewer
  • Patients with serum PSA 1 micrograms/L (1 ng/mL) or more
  • Patients with no confirmed remote metastasis after diagnosis of prostate cancer (excluding lymph nodes metastasis with a minor axis of less than 15 mm which considered to be nonmeasurable in the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1)
  • Patients with asymptomatic prostate cancer
  • Patients with the Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Patients with life expectancy of at least 12 months
  • Patients who have signed written informed consent to participate in this study

Who cannot join

  • Patients with history of any chemotherapy (including estramustine phosphate sodium hydrate (JAN)) or treatment with enzalutamide or abiraterone acetate
  • Patients with history of steroid usage as treatment for prostate cancer
  • Patients with history of 5-alpha-reductase inhibitor, estrogen or steroidal antiandrogen within past 4 weeks prior to initial administration of enzalutamide
  • Patients with history of malignant tumor other than prostate cancer within past 3 years
  • 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.

Trial locations and contacts

4 sites in 1 country.

Japan4 sites

  • Kagawa University Faculty of Medicine

    Kita-gun, Kagawa-ken, 761-0793

  • Tokyo Medical Center

    Meguro-ku, Tokyo, 152-8902

  • The Jikei university school of medicin

    Minato-ku, Tokyo, 105-8461

  • University of Miyazaki Faculty of Medicine

    Miyazaki, Miyazaki, 889-1692

Other trials in Japan

About this study

The purpose of this study is to investigate the efficacy and safety of enzalutamide in patients with non-metastatic castration resistant prostate cancer. The total duration of the study will be 5 years. All patients will receive enzalutamide 160 mg (four 40 mg capsules) orally once daily. The treatment will be started at Visit 0 within one week after enrollment. Visit 1 is at 2 weeks after the treatment started; clinical assessments are conducted on adverse events and the Japanese version of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) scales. Patients who are considered to be adequate by the investigator can continue the treatment with 12-week cycle visit (counted from initial dose) until patients meet withdrawal criteria. Patients will be followed up at 2 and 3 years after enrollment and at 3 years after the last participant enrollment. The end of the study is defined as follow-up assessment date at 3 years after the last participant enrollment. Patients will primarily be assessed by prostate-specific antigen (PSA) progression-free survival (PFS).

Conditions
Prostate Cancer
Being tested
Enzalutamide
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • EnzalutamideDrug

    All patients will receive enzalutamide 160 mg (four 40 mg capsules) orally once daily. The treatment will be started at Visit 0 within one week after enrollment. Visit 1 is at 2 weeks after the treatment started; clinical assessments are conducted on adverse events and the Japanese version of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) scales. Patients who are considered to be adequate by the investigator can continue the treatment with 12-week cycle visit (counted from initial dose) until patients meet withdrawal criteria. Patients will be followed up at 2 and 3 years after enrollment and at 3 years after the last participant enrollment.

Study groups in NCT02588001
Study groupRoleWhat they receive
Enzalutamide GroupExperimentalNot described
Receives: Drug: Enzalutamide

What is being measured

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

  1. PSA-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.

    Measured: 6 years

Secondary outcomes (11)

  1. Overall survival (OS)

    OS is defined as time from date of initial dose until date of death from any cause.

    Measured: 6 years

  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.

    Measured: 6 years

  3. Metastasis free survival (MFS)

    MFS is defined as time from date of initial dose until the date of first metastasis which confirmed by computed tomography (CT) and bone scintigraphy.

    Measured: 6 years

  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).

    Measured: 6 years

  5. PSA response rate

    PSA response rate is defined as ratio of patients who have an decrease in PSA of >= 50% above baseline, compared to PSA levels at week 2, every 12 weeks for up to 5 years after initial dose.

    Measured: At week 2, and every 12 weeks for up to 6 years after initial dose

  6. Time to first use of chemotherapy (TFC)

    TFC is defined as time from date of initial dose until the date of first additional chemotherapy started for prostate cancer.

    Measured: 6 years

  7. QOL assessment using Japanese version of the FACT-P scales

    Quality of life (QOL) is assessed on both total scores and each domain scores using Japanese version of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) scales at baseline, week 2, week 60, withdrawal of treatment and at the end of treatment for up to 5 years.

    Measured: Baseline, week 2, week 60, at withdrawal of treatment and at end of treatment for up to 6 years

  8. Medication adherence (dosage)

    Medication adherence is assessed in dosage of enzalutamide.

    Measured: 6 years

  9. Medication adherence (duration)

    Medication adherence is assessed in duration of enzalutamide.

    Measured: 6 years

  10. Medication adherence (ratio)

    Medication adherence is assessed in dosage rate of enzalutamide which is classfied into 3 categories: 1) >=80%, 2) >= 50% to < 80%, and 3) < 50%.

    Measured: 6 years

  11. Safety assessment on the incidence and severity of adverse events using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

    Measured: 6 years

Timeline

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

  1. First posted27 Oct 2015 (estimated)
  2. Study start1 Oct 2015
  3. Primary completion31 Mar 2020
  4. Study completion31 Mar 2021

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02588001
Sponsor's protocol ID
TRIGU1506
Other IDs
UMIN000018964
Acronym
JCASTRE-Zero
Status last verified
May 2022
First submitted
23 Oct 2015
Last updated
25 May 2022
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Enzalutamide in people with Prostate Cancer, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 4 sites 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 12 inclusion and 8 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 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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.

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?

PSA-progression-free survival (PSA-PFS) (time frame: 6 years). 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 NCT02588001.

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 25 May 2022.

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