Prostate Cancer Clinical Trial
The Effect of Zoledronic Acid on Bone Loss in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy
Summary
The purpose of this study is to compare the effect of an investigational drug used intravenously and placebo administered every three months for one year, on bone loss associated with initial androgen deprivation) in men with prostate cancer without metastasis. In order to participate in this trial male patients must be 18 years of age or older and have been diagnosed with prostate cancer without metastasis and within one year of starting their androgen deprivation therapy at the day of randomization onto this trial. In addition, patients who have undergone a recent orchiectomy (or"ke-ek'te-me) (removal of one or two testes) are eligible to participate.
Patients who received any prior bisphosphonate therapy or prior treatment with systemic corticosteroids within in the past 12 months are not eligible to participate. Also patients who are receiving treatment for osteoporosis are not eligible to participate.
Inclusion into this clinical trial with this investigational drug is based on the protocol entry criteria and evaluation from a participating trial investigator.
Eligibility Criteria
Histologically confirmed diagnosis of carcinoma of the prostate
No distant metastases (stage TNMO) (ie. prostate cancer without metastases)
Patients within one year at the day of randomization from initiation of androgen deprivation therapy with a LHRH agonist (with or without an antiandrogen) and with the intended duration of androgen deprivation therapy of at least 12 months. Patients may also enter if they have received an orchiectomy (or"ke-ek'te-me) within two weeks of visit 1
Patients who received any prior bisphosphonate therapy in the past 12 months will be excluded
Patients who are currently receiving diethylstilbesterol (DES) or PC-SPES (treatment for osteoporosis) will be excluded
Patients who have received prior treatment with systemic corticosteroids within the past 12 months will be excluded (short term corticosteroid therapy, e.g. to prevent/treat chemotherapy-induced nausea/vomiting or for acute illness like asthma exacerbation, is acceptable)
Other eligibility criteria may apply
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There are 42 Locations for this study
Birmingham Alabama, 35205, United States
Huntsville Alabama, 35801, United States
Anchorage Alaska, 99508, United States
Tucson Arizona, 85712, United States
Tucson Arizona, 85712, United States
Little Rock Arkansas, 72211, United States
Anaheim California, 92801, United States
Long Beach California, 90806, United States
San Diego California, 92101, United States
Torrance California, 90505, United States
Hartford Connecticut, 06106, United States
New Britain Connecticut, 06052, United States
Daytona Beach Florida, 32114, United States
Miami Florida, 33176, United States
New Port Richey Florida, 34652, United States
Ocala Florida, 34470, United States
Tallahassee Florida, 32308, United States
Evansville Indiana, 47714, United States
Des Moines Iowa, 50309, United States
Owings Mills Maryland, 21117, United States
Southfield Michigan, 48075, United States
Springfield Nebraska, 68059, United States
Marlton New Jersey, 08053, United States
Morristown New Jersey, 07962, United States
West Orange New Jersey, 07052, United States
Garden City New York, 11530, United States
Garden City New York, 11530, United States
Staten Island New York, 10304, United States
Cincinnati Ohio, 45212, United States
Columbus Ohio, 43222, United States
Mount Vernon Ohio, 43050, United States
Eugene Oregon, 97401, United States
Portland Oregon, 97210, United States
Allentown Pennsylvania, 18103, United States
Philadelphia Pennsylvania, 19141, United States
Pittsburgh Pennsylvania, 15212, United States
Providence Rhode Island, 02904, United States
Providence Rhode Island, 02906, United States
Myrtle Beach South Carolina, 29572, United States
Germantown Tennessee, 38138, United States
San Antonio Texas, 78229, United States
Salt Lake City Utah, 84124, United States
Seattle Washington, 98704, United States
Spokane Washington, 99220, United States
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