PhII One Label Non-Comparative Trial in Metastatic Hormone Refractory Prostate Cancer in Combination With Prednisolone

A Multicenter Phase II Open Label Non-Comparative Trial of RP56976 Administered Every Three Weeks in Combination With Daily Prednisolone for Metastatic Hormone Refractory Prostate Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00291005

Enrollment

Registered

2006-02-13

Start date

2004-08-31

Completion date

Unknown

Last updated

2009-03-27

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

Conditions

Prostatic Neoplasms

Keywords

Prostate cancer, HRPC, AIPC, Hormone refractory, Androgen independent, Docetaxel, Taxotere, prednisolone

Brief summary

* To evaluate the overall tumor response rate in subjects with metastatic hormone refractory prostate cancer * To evaluate PSA (tumor marker) response rate * To evaluate safety

Interventions

DRUGARD6562, Docetaxel

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 74 Years

Healthy volunteers

Inclusion criteria

* Men with prostate adenocarcinoma with at least one metastatic lesion which is measurable and who progressed after prior hormonal therapy.

Exclusion criteria

* 1.Body temperature \> 38 degree centigrade. * 2.Prior radiotherapy to \> 25% of bone marrow. * 3.Prior isotope therapy and/or brachytherapy * 4.Prior gene therapy. * 5.Active double cancer. * 6.Known brain or leptomeningeal involvement. * 7.History of hypersensitivity reaction to drug * 8.Other serious illness or medical condition * 9.Subjects whom the investigators consider inappropriate from social or medical aspects.

Design outcomes

Primary

Measure	Time frame
Overall tumor response rate by Response Evaluation Criteria in Solid Tumor (RECIST)	—

Secondary

Measure	Time frame
Overall response rate by modified WHO criteria, PSA response rate, safety	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026