NCT02588001: JCASTRE-Zero

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

Completed NA Last updated 25 May 2022

What this trial tests

NA trial testing Enzalutamide in Prostate Cancer in 60 participants. Completed in 31 March 2021.

Timeline

1 October 2015

Primary endpoint
31 March 2020

31 March 2021

Quick facts

Lead sponsor	Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	1 October 2015
Primary completion	31 March 2020
Estimated completion	31 March 2021
Sites	4 locations across Japan

Drugs / interventions tested

• Enzalutamide (enzalutamide) — full drug profile →

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan — full company profile →

Who can join

20 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Real-world use of enzalutamide in men with nonmetastatic castration-resistant prostate cancer in Japan.
   Yokomizo A, Yonese J, Egawa S, Fukuhara H, et al · · 2022 · cited 8× · PMID 34779962 · DOI 10.1007/s10147-021-02070-z
2. Treatment Landscape of Nonmetastatic Castration-Resistant Prostate Cancer: A Window of Opportunity.
   López-Campos F, Conde-Moreno A, Barrado Los Arcos M, Gómez-Caamaño A, et al · · 2021 · cited 6× · PMID 34834544 · DOI 10.3390/jpm11111190