Exploration of Predictive factors for response to Enzaltamide in bone metastasis of Prostate cancer

Exploration of Predictive factors for response to Enzaltamide in bone metastasis of Prostate cancer - EPEP study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000018634

Enrollment

100

Registered

2015-08-10

Start date

2015-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone metastasis of prostate cancer

Interventions

None listed

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. 20 years old or more 2. Diagnosed as prostate cancer by histological examination and also have 2 or more bone metastasis by CRPC. 3. Testosterone < 50ng/dL 4. Progression on the image or PSA relapse 5. 2 months or more has passed from operation for metastasis or radiation therapy. 6. PS of ECOG; 0-2 7. Liver and renal function are adequate 8. Life expectancy is more than 6 months

Exclusion criteria

Exclusion criteria: 1. Patients treated by chemotherapy 2. Patients judged to be inappropriate to perform this study by investigator

Design outcomes

Primary

Measure	Time frame
BSI responder rate 3 months, 6 months, reccurence point	—

Secondary

Measure	Time frame
Response rate of 50 percent of PSA PFS, OS QOL SF-8, EPIC, FACT-P, I-PSS ,QOL score for urination OS Time to chemotherapy Expression of micro RNA in blood CTC and character change of androgen receptor	—

Countries

Japan

Contacts

Public ContactHaruna Haruna

Juntendo University Graduate School of Medicine Department of Urology

harunase@juntendo.ac.jp03-3813-3111

Outcome results