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Completed Phase 2 Interventional Results available

Satraplatin and Prednisone to Treat Prostate Cancer

ClinicalTrials.gov ID: NCT00634647

Public ClinicalTrials.gov record NCT00634647. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 10:40 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase II Study of Satraplatin and Prednisone in Metastatic Androgen Independent Prostate Cancer (AIPC)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Background: Satraplatin is an experimental drug that may be of benefit to patients with prostate cancer. Prednisone is approved for treating prostate cancer. The gene excision repair cross-complementing rodent repair deficiency complementation group 1 (ERCC1) helps repair cell damage caused by satraplatin. It is possible that patients who have a variant of this gene will not benefit from treatment with satraplatin because the drug will not be able to damage the cancer cells effectively. Objectives: To determine if satraplatin may help treat prostate cancer in patients with certain variants of the ERCC1 gene. Eligibility: Patients with advanced androgen-independent prostate cancer whose disease has not responded to hormonal therapy or at least one type of chemotherapy and whose x-rays, scans or other tests have shown their cancer to be spreading. Design: Participants have a blood test to determine if they have a variant of the ERCC1 gene. Participants take satraplatin by mouth every day for 5 consecutive days out of every 35 days and prednisone by mouth every day. These 35-day treatment cycles may continue for 6 months or longer, depending on the benefits and side effects of the treatment. During the treatment period, patients undergo the following tests and procedures: * Blood tests on days 1 of the treatment cycle. * Weekly blood draws for the first 3 treatment cycles. * Imaging studies (e.g., bone scans, computed tomography (CT) scans) every two cycles to determine the response to treatment. * Surgical or medical suppression of testosterone in patients whose cancer cells continue to grow due to exposure to the hormone....

Study identification

NCT ID
NCT00634647
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Enrollment
24 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 18, 2008
Primary completion
Jan 31, 2011
Completion
Apr 30, 2012
Last update posted
Oct 1, 2018

2008 – 2012

United States locations

U.S. sites
2
U.S. states
1
U.S. cities
2
Facility City State ZIP Site status
National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland 20892
Associates in Oncology and Hematology Rockville Maryland 20850

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00634647, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 1, 2018 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00634647 live on ClinicalTrials.gov.

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