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

NCT02588001 | Completed DMC

• 2 other identifiers: TRIGU1506UMIN000018964
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

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).

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (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.

  6 years

Secondary Outcomes (11)

• Overall survival (OS)

  6 years

• Progression-free survival (PFS)

  6 years

• Metastasis free survival (MFS)

  6 years

• Time-to-PSA-progression (TTPP)

  6 years

• PSA response rate

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

Study Arms (1)

Enzalutamide Group

EXPERIMENTAL

Drug: Enzalutamide

Interventions

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.

Enzalutamide Group

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan: lead
• Kagawa University: collaborator

Study Sites (4)

Kagawa University Faculty of Medicine

Kita-gun, Kagawa-ken, 761-0793, Japan

Location

University of Miyazaki Faculty of Medicine

Miyazaki, Miyazaki, 889-1692, Japan

Location

Tokyo Medical Center

Meguro-ku, Tokyo, 152-8902, Japan

Location

The Jikei university school of medicin

Minato-ku, Tokyo, 105-8461, Japan

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

enzalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Mikio Sugimoto, MD, Ph.D.

  Kagawa University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: October 27, 2015
• Study Start: October 1, 2015
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2021
• Last Updated: May 25, 2022

Record last verified: 2022-05

Locations

JP (4)