Trial Information

Summary: Docetaxel and Estramustine versus Mitoxantrone and Prednisone for Advanced Hormone Refractory Prostate Cancer, Phase III
Sponsor: CALGB

This research study will compare two active chemotherapy regimens(docetaxel and estramustine versus mitoxantrone and prednisone) on advanced prostate cancer which no longer responds to hormone therapy to see the benefit of either treatment. If the treatment works, it may provide a cure and/or prolong life or improve the quality of life. There is no guarantee of benefit with participation in this study. Participants will be assigned a treatment by chance, a method known as randomization. The chances of receiving either treatment are approximately equal. There is no payment for participation in this research study.
No Compensation Provided

Patient Inclusion/Exclusion Criteria:

1)Prostate Cancer which has come back after initial treatment and continues to grow despite hormone therapy. This is evaluated by one of the following:
a)Presence of metastatic (outside the area of the prostate gland) disease on bone scan, CT scan or MRI;
b) Presence of growing prostate cancer found during physical exam by your doctor;
c)Rising Prostate Specific Antigen(PSA) defined as two consecutive rises in PSA level (each at least seven days apart) above initial measurement. The first PSA reading must be greater than or equal to 5ng/dl.

1) History of Heart Attack, Stroke, or Atrial Fibrillation(Rapid Heart Beat diagnosed by your doctor) ;
2) Presence of metastatic prostate cancer in the brain;
3) History of inflammation of the veins or presently taking Coumadin(Warfarin);
4) Diagnosis of another type of cancer other than prostate or adequately treated basal/squamous cell cancer of the skin

Contact:

Valerie Coffey-Carlson, Clinical Research Coordinator
Mount Sinai Medical Center
One Gustave L. Levy Place

New York, NY 10029
Telephone: (212)241-8617
Fax: (212)289-2663
Email:

If you would like to learn more about participating in this study, please send an e-mail message using the form below.

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Trial listings updated: June 1, 2008 at 5:43:25 AM


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