Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Japanese Research for Patients With Non-metastatic Castration Resistant Prostate Cancer - Enzalutamide (JCASTRE-Zero)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02588001
Recruitment Status : Active, not recruiting
First Posted : October 27, 2015
Last Update Posted : June 13, 2019
Sponsor:
Collaborator:
Kagawa University
Information provided by (Responsible Party):
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Brief 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. 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).

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Enzalutamide Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Japanese Research for Patients With Non-metastatic Castration Resistant Prostate Cancer - Enzalutamide
Actual Study Start Date : October 1, 2015
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Enzalutamide Group Drug: Enzalutamide
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 Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with histologically or cytologically confirmed prostate cancer
  2. Patients with history of radical prostatectomy or radiation therapy for radical treatment
  3. Patients who receive continuous androgen deprivation therapy using both gonadotropin-releasing hormone (GnRH) agonist and antagonist, or using surgical castration
  4. Patients with serum testosterone 1.73 nmol/L (0.50 ng/dL) or less
  5. Patients with history of bicalutamide or flutamide at any time after first recurrence confirmed since radical treatment completed
  6. Patients with 3 increased PSA test results which measured consecutively at least one week apart during androgen deprivation therapy
  7. Patients with serum PSA 1 micrograms/L (1 ng/mL) or more
  8. 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)
  9. Patients with asymptomatic prostate cancer
  10. Patients with the Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  11. Patients with life expectancy of at least 12 months
  12. Patients who have signed written informed consent to participate in this study

Exclusion Criteria:

  1. Patients with history of any chemotherapy (including estramustine phosphate sodium hydrate (JAN)) or treatment with enzalutamide or abiraterone acetate
  2. Patients with history of steroid usage as treatment for prostate cancer
  3. Patients with history of 5-alpha-reductase inhibitor, estrogen or steroidal antiandrogen within past 4 weeks prior to initial administration of enzalutamide
  4. Patients with history of malignant tumor other than prostate cancer within past 3 years
  5. Patients with history of seizure or predisposing disease of seizure
  6. Patients with severe liver dysfunction
  7. Patients with a previous history of hypersensitivity to any component of drugs which will be administered in this study
  8. Patients who considered to be inappropriate for the study participation by the investigator.

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): NCT02588001


Locations
Layout table for location information
Japan
Kagawa University Faculty of Medicine
Kita-gun, Kagawa-prefecture, Japan, 761-0793
University of Miyazaki Faculty of Medicine
Miyazaki-city, Miyazaki-prefecture, Japan, 889-1692
Tokyo Medical Center
Meguro-ku, Tokyo, Japan, 152-8902
The Jikei university school of medicin
Minato-ku, Tokyo, Japan, 105-8461
Sponsors and Collaborators
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Kagawa University
Investigators
Layout table for investigator information
Principal Investigator: Mikio Sugimoto, MD, Ph.D. Kagawa University

Layout table for additonal information
Responsible Party: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier: NCT02588001     History of Changes
Other Study ID Numbers: TRIGU1506
UMIN000018964 ( Registry Identifier: UMIN-CTR )
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019

Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases