Status:
TERMINATED
Risedronate to Prevent Skeletal Related Events in Patients With Metastatic Prostate Cancer Commencing Hormonal Therapy
Lead Sponsor:
Christopher Sweeney, MBBS
Collaborating Sponsors:
Sanofi
Walther Cancer Institute
Conditions:
Metastatic Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
Risedronate is an orally administered pyridinyl bisphosphonate that is 36 times more potent than pamidronate and 72 times more potent than clodronate. Four randomized, double-blind trials have been ca...
Detailed Description
OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter, 2 arm study. The study population will consist of prostate cancer patients with metastatic bone disease for whom androgen...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed adenocarcinoma of the prostate with metastatic bone disease (by CT, MRI or bone scan) with plans to start or be \< 30 days from beginning androgen deprivation therapy. Patients with lymph node or visceral metastases only are not eligible
- Patients may receive palliative radiation therapy at the investigators discretion during the first 4 weeks of beginning protocol therapy.
Exclusion
- No neuroendocrine, small cell or transitional cell cancer of the prostate No abnormal bone metabolism (i.e., Paget's disease, untreated hyperthyroidism, untreated hyperprolactinemia, untreated Cushing's disease).
- No use of calcitonin within 14 days before being registered for protocol therapy or any previous use of bisphosphonates.
- No major surgery within 4 weeks of registration to protocol therapy.
- No adjuvant chemotherapy within 6 months of registration to protocol therapy.
- No previous chemotherapy for metastatic disease.
- No hormonal therapy in the adjuvant setting within 12 months of registration to protocol therapy; previous hormonal therapy must not have exceeded 6 months.
- No prior history of malignancy in the past 5 years with the exception of basal cell and squamous cell carcinoma of the skin.
- No history of allergy or drug reactions to bisphosphonates.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00216060
Start Date
October 1 2003
End Date
March 1 2008
Last Update
May 26 2016
Active Locations (45)
Enter a location and click search to find clinical trials sorted by distance.
1
Center for Urological Research
La Mesa, California, United States, 91942
2
San Bernadino Urological Associates
San Bernardino, California, United States, 92404
3
Grove Hill Medical Center Urology
New Britain, Connecticut, United States, 06052
4
Innovative Surgical Resources
Tampa, Florida, United States, 33607