A Study to Determine Enzalutamide Long-term Safety and Efficacy After Anti-androgen Therapy for CRPC (DELC)

This is a prospective observational study to evaluate effectiveness and safety of Enzalutamide for Castration Resistant Prostate Cancer (CRPC) patients who decided to administer Enzalutamide after anti-androgen therapy.

CRPC Patients who are observed PSA or disease progression after anti-androgen therapy and decided to administrate Enzalutamide will dose the Enzalutamide 160 mg orally once daily and observed the practical treatment. Total research term is for 4 years, consists of 2-year case registration terms and 2-year observational terms.

Study Overview

• Status: Completed
• Conditions: Castration Resistant Prostate Cancer (CRPC)

• Study Type: Observational
• Enrollment (Actual): 160

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

CRPC patients who are observed PSA or disease progression after anti-androgen therapy and decided to administrate Enzalutamide

Description

Inclusion Criteria:

1. Patients with histologically or cytologically confirmed prostate cancer.
2. Patients who are receiving or received continuous androgen deprivation therapy using both gonadotropin-releasing hormone (GnRH) agonist and antagonist (medical castration), or both testicles removal by surgery (surgical castration).
3. Castration resistant prostate cancer (CRPC) patients who are observed disease progression after castration treatment and implied the treatment resistant.

4. CRPC patients who conducted anti-androgen alternating therapy as shown below 1) and are observed one or more of disease progression shown as below 2) during or after the therapy and decided to administer enzalutamide.

   Note 1) anti-androgen alternating therapy is defined as the therapy of flutamide administration after bicalutamide.

   Note 2) Disease progression criteria during or after anti-androgen alternating therapy

   ① PSA progression during or after anti-androgen alternating therapy: PSA increased more than 25% compare to the lowest test results after initial dose of anti-androgen alternating therapy (flutamide) and the increasing is more than 2ng/ml.

   ②Confirmed disease progression of soft tissue lesion defined as RECIST v1.1.

   ③Confirmed disease progression of bone lesion defined as 2 or more of new appearance of bone lesion on bone scintigraphy.

5. Patients with the Eastern Cooperative Oncology Group (ECOG) performance status 0-2
6. Patients who have signed written informed consent to participate in this study

Exclusion Criteria:

1. Patients who is administering or have administration history of enzalutamide, abiraterone, docetaxel or cabazitaxel
2. Patients with history of seizure or predisposing disease of seizure
3. Patients with severe liver dysfunction
4. Patients with a previous history of hypersensitivity to any component of drugs which will be administered in this study
5. Patients who considered to be inappropriate for the study participation by the investigator

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	OS is defined as time from date of initial dose until date of death from any cause. In the case of any new chemotherapy added or changed to another treatment to prostate cancer, the conducted date will be applied. When patient is no longer traceable, the final confirmed date as alive will be applied to OS.	50 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prostate Specific Antigen-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. In the case of any new chemotherapy added or changed to another treatment to prostate cancer, the conducted date will be applied.	50 months
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. Progression is defined as followed:① A growth of primary lesion or appearance of neopathy by image diagnosis, aggravation of general condition・PS decrease or noticable weight loss which investigator assess as progression. ②Unmeasurable or difficult to measure lesion which newly appeared or investigator assess as obvious aggravation. ③ In the case of any new chemotherapy added or changed to another treatment to prostate cancer	50 months
Time to Treatment Failure (TTTF)	TTTF is defined as time from date of initial dose until the date of any new chemotherapy added or changed to another treatment to prostate cancer.	50 months
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). In the case of any new chemotherapy added or changed to another treatment to prostate cancer, the conducted date will be applied.	50 months
PSA response rate	PSA response rate is defined as ratio of patients who have an decrease in PSA of >= 50% above baseline since initial dose.	50 months
Time to First Symptomatic Skeletal Events (TTFS)	TTFS is defined as time from date of initial dose until the date of first confirmed skeletal-related event. In the case of any new chemotherapy added or changed to another treatment to prostate cancer, the conducted date will be applied. Symptomatic Skeletal Events (SSE) defined as followed: ・Operation of EBRT External Beam Radiation Therapy (EBRT) to mitigate skeletal events ・New appearance of symptomatic pathological fracture ・Appearance of spinal cord compression ・Orthopedic intervention related to tumor	50 months
The state of administration	The state of administration is assessed by Relative Dose Intensity (RDI). RDI is calculated by dosage and dosing period. RDI calculation formula =∑ (daily dosage ×dosing days) / (160mg ×total dosing number of days). ∑ means all total dose which adds up in different dosage. Total number of days mean treatment term of this trial.	2 years
Safety assessment	Safety assessment by the incidence and severity of adverse events as assessed by Japanese version of the Common Terminology Criteria for Adverse Events (CTCAE) version 4.00	50 months

Collaborators and Investigators

• Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
• Investigators: Study Chair: Norio Nonomura, MD, Ph.D., Osaka University Graduate School Of Medicine, Department of Urology

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2016
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: January 27, 2016
• First Submitted That Met QC Criteria: January 27, 2016
• First Posted (Estimate): January 29, 2016

Study Record Updates

• Last Update Posted (Actual): December 28, 2022
• Last Update Submitted That Met QC Criteria: December 25, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: TRIGU1517; UMIN000019855 (Other Identifier: UMIN-CTR)