Examination of the effectiveness and safety of multidisciplinary therapy with docetaxel for high-risk prostate cancer

Examination of the effectiveness and safety of multidisciplinary therapy with docetaxel for high-risk prostate cancer - Multidisciplinary therapy with docetaxel for high-risk prostate cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000023145

Enrollment

100

Registered

2016-09-01

Start date

2016-08-01

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

prostate cancer

Interventions

chemotherapy with docetaxel for hormone-sensitive high-risk prostate cancer. DOC 70mg/m2 per 3 or 4 weeks, 6 cycles

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Histologically proven adenocarcinoma of the prostate. 2. Must be male and 20 years or older with criteria for administration of docetaxel. 3. Meet either following conditions by MRI/CT, bone scan, or biopsy at diagnosis; PSA > 50ng/ml, Gleason score > 8-10, locally invasive (T3b or 4), viceral metastases, or high volume cancer with multiple metastases. 4. Give informed consent. 5. ECOG Performance Status of 0 or 1.

Exclusion criteria

Exclusion criteria: 1.Males under the age of 20. 2. Refuses to give informed consent. 3. Refuses or is unable to have pelvic MRI or CT scan. 4. Without criteria for administration of docetaxel. 5. Deemed higher risk of administration of docetaxel by urologists or other physicians.

Design outcomes

Primary

Measure	Time frame
biochemical recurrence-free survival (PSA)	—

Secondary

Measure	Time frame
overall survival, safety of radiation therapy or surgery after administration of docetaxel	—

Countries

Japan

Contacts

Public ContactMasayoshi Nagata

Juntendo University, Graduate School of Medicine Department of Urology

m-nagata@juntendo.ac.jp03-5802-1227

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026