Effect of Androgen Ablation on Bone Resorption in Prostate Cancer Patients
This study aims to investigate how androgen ablation therapy affects bone resorption in individuals undergoing treatment for prostate cancer.
management of therapy complications
Urogenital Diseases+13
+ Genital Diseases
+ Bone Diseases
Supportive Care Study
Summary
Study start date: July 1, 1999
Actual date on which the first participant was enrolled.OBJECTIVES: Evaluate the effect of androgen ablation on bone resorption in patients with or without bone metastases secondary to prostate cancer. OUTLINE: Patients are stratified according to prior androgen ablation therapy (yes vs no) and metastatic disease (yes vs no). Patients undergo blood work and 24 hour urine collection on day 1 and at week 6-8. Patients who have received androgen ablation therapy and are found to have increased bone resorption undergo a dual energy x-ray absorptiometry (DEXA) scan. A comparison is made between androgen ablation therapy and bone resorption and if metastases are associated with the two. PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study within 9 months.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.150 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed prostate cancer Stratum 1 (androgen ablation therapy): Bone metastases Prior orchiectomy allowed Prior or concurrent leuprolide and/or goserelin therapy allowed Stratum 2 (androgen ablation therapy): No bone metastases Prior orchiectomy allowed Prior or concurrent leuprolide and/or goserelin therapy allowed Stratum 3 (no androgen ablation therapy): No metastatic disease Prior flutamide or bicalutamide therapy allowed PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Calcium normal Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: See Disease Characteristics No concurrent high dose steroids Radiotherapy: Prior radiotherapy allowed Surgery: See Disease Characteristics Prior radical prostatectomy allowed Other: No concurrent bisphosphonates
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
James P. Wilmot Cancer Center
Rochester, United StatesOpen James P. Wilmot Cancer Center in Google Maps