Brief Summary

To evaluate the efficacy of SR31747 given at 75 or 125mg per day versus placebo in androgen prostate cancer patient without distant metastases with Time to Clinical progression as main objective and PSA parameters, Tumor response, survival , safety,Tumor-related symptoms deterioration Quality of Life, PK analysis as secondary objectives

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

232

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Oct 2003

Typical duration for phase_2

Geographic Reach

13 countries

13 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.8 years study duration

Study Start

First participant enrolled

October 1, 2003

Completed

2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed

Last Updated

December 23, 2008

Status Verified

December 1, 2008

Enrollment Period

2.8 years

First QC Date

September 13, 2005

Last Update Submit

December 22, 2008

Conditions

Prostatic Neoplasm

Outcome Measures

Primary Outcomes (1)

Time To Clinical Progression assessed by every 4 weeks clinical examination and every 12 weeks radiological examinations (Thoraco-abdominopelvic CT scan ; Bone scan ± centered Bone X-rays, MRI)

Secondary Outcomes (2)

Every 4 weeks: Clinical examination (safety, Tumor related symptoms deterioration), PSA level determination (PSA endpoints), EuroQoL instrument (Quality of Life), Laboratory tests (Hematology, Biochemistry), one PK sample
Every 12 weeks: radiological examinations (tumor response),

Interventions

SR31747ADRUG

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Prior confirmed histological diagnosis of prostatic carcinoma.
Rising PSA while receiving hormonal therapy or after surgical castration defined as 2 sequential increases above a previous lowest reference value within the past 12 months; PSA must be at least 4ng/ml at the time of study entry.
No distant metastases as evidenced by bone scan (+ or - centered X-Ray or MRI), and spiral thoracoabdominopelvic CT scan.
Effective castration throughout the study. Any prior anti-androgen therapy should be stopped with documented continued elevation of PSA 4 weeks after the cessation of flutamide (6 weeks for bicalutamide).
Serum testosterone levels \< 50ng/dL at the time of progression and throughout the study.
Age \> or = to 18 years.
Extensive metabolizer by CYP2D6 genotyping.
Karnofsky Performance Status \> or = to 70% and life expectancy \> 6 months.
Adequate hematological, renal and liver function.
Signed written informed consent

You may not qualify if:

Poor metabolizers by CYP2D6 genotyping.
Prior palliative radiotherapy or any prior chemotherapy or experimental therapy.
More than one line of any prior anticancer treatment with estrogen (estrogen or estramustine) if discontinued at least 4 weeks before study entry.
Concomitant administration of biphosphonate or chronic corticosteroids.
Presence of progressive symptoms not adequately controlled with non opioid medications
Concomitant use of medications known to be cytochrome P450 2D6 inhibitors as listed in protocol appendice
Previous malignancies except if there has been a disease-free interval of at least 5 years and except curatively treated non-melanoma skin cancer
Other serious illness or medical condition, which would not permit the patient to be managed according to the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Sanofilead