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Completed

NCT Number: NCT02588001

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

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).

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

20 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Kagawa University Faculty of Medicine, Kita-gun, Kagawa-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Enzalutamide

Drug

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.

Primary outcomes

  1. PSA-progression-free survival (PSA-PFS)

    Time frame: 6 years

    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.

Secondary outcomes

  1. Overall survival (OS)

    Time frame: 6 years

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

  2. Progression-free survival (PFS)

    Time frame: 6 years

    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.

  3. Metastasis free survival (MFS)

    Time frame: 6 years

    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.

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

    Time frame: 6 years

    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).

  5. PSA response rate

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

    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.

  6. Time to first use of chemotherapy (TFC)

    Time frame: 6 years

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

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

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

    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.

  8. Medication adherence (dosage)

    Time frame: 6 years

    Medication adherence is assessed in dosage of enzalutamide.

  9. Medication adherence (duration)

    Time frame: 6 years

    Medication adherence is assessed in duration of enzalutamide.

  10. Medication adherence (ratio)

    Time frame: 6 years

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

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

    Time frame: 6 years

Sponsors and collaborators

Lead sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Other

Collaborators

  • Kagawa University

Registry information

Acronym: JCASTRE-Zero

Important dates

Study start
2015
Primary completion
2020
Study completion
2021
First posted
Oct 27, 2015
Registry last updated
May 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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