Status:
TERMINATED
Cancer and Osteoporosis Research With Alendronate and Lupron (C.O.R.A.L )
Lead Sponsor:
Canadian Urology Research Consortium
Collaborating Sponsors:
Abbott
Merck Frosst Canada Ltd.
Conditions:
Osteoporosis
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
Multi-center,double blind randomized phase III placebo controlled study in 250 men with histologically proven prostate cancer with out bone metastases who are beginning ADT therapy and who will receiv...
Detailed Description
This is a phase three multicentre, double blind, randomize parallel group, placebo-controlled study in 250 men with histologically proven cancer without bone metastases who are beginning ADT therapy a...
Eligibility Criteria
Inclusion
- Histologically/cytologically proven, non-metastatic (M0) adenocarcinoma of the prostate.
- Life expectancy of \> 12 months.
- Initiation of treatment with the luteinizing hormone-releasing hormone agonist (LHRH-a) Lupron no more than 15 days prior or 30 days following, baseline visit.
- Requiring treatment with LHRH agonists for prostate cancer, for a duration of at least 12 months from baseline.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- Prior to any study-specific procedures, subject (and/or their legally authorized representative) has voluntarily signed and dated an informed consent form.
Exclusion
- Bone Metastases Current or previous use with in past 12 months of bisphosphonate. Known hypersensitivity to LHRH. Hypocalcaemia. Severe renal impairment, Abnormal liver function, Hypothyroidism, Hyperthyroidism, Bilateral hip replacement.
- Use of LHRH or anti-androgen medication within last 12 months. Abnormalities of esophagus which delay esophageal emptying. Inability to stand or sit upright for at least 30 minutes.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT00236002
Start Date
July 1 2005
End Date
August 1 2009
Last Update
August 12 2009
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