Prostate Cancer Clinical Trials 1
One of the more recent prostate cancer clinical trials dealt with early detection of metastases in the bones of patients who have prostate cancer that is considered high risk. This trial was a clinical study that was meant to assess whether the parameters of bone cancer can be useful as a diagnostic tool in the early detection of these bone metastases. Specifically, it was intended to show whether patients who have prostate cancer that is considered high risk can be assessed with the information provided by the bone cancer parameters.
The patients included in this study had confirmed cases of prostate cancer, but had not yet developed any bone metastases. Patients also may have had a rise in PSA while undergoing hormone therapy. Some patients had undergone prostatectomy with any PSA rise and some patients without prostatectomy had two rises in consecutive PSA levels, as compared to a previously established reference value. The original measurement was to have occurred a month after the reference value was established. The second measurement was to have been taken a month after the first one, and it had to have been greater than the first one.
Patients may have had previous radiography or chemotherapy, but this had to have been administered greater than or equal to eight weeks before the study began. This would include patients who have a score of zero, one or two on the Eastern Cooperative Oncology Group, which includes patients who spend less than half of their daily time in bed. Patients must also have had normal liver function and they were all eighteen years of age or older.
Patients not included in the study were those who had been treated with a biophosphonate, those with renal function not considered normal, and those with a history of any diseases that might influence bone metabolism. Also not included in this study were patients with psychological or physical diseases that might have impaired their compliance with study protocol provisions.
In addition, patients not included in the study were those who were sensitive to zoledronic acid or indeed to other bisphosphonates, and those who used investigational drugs in the previous thirty days before the beginning of the study. Patients who abused drugs or alcohol were not allowed, so that the information wouldn’t be affected by use of these drugs. Patients who would likely not cooperate during the trial were excluded, as were people with active problems in dentition, which included infection of the jawbone or teeth.
Roughly 33% of the men who started the trial did complete it. Of the group that received 4 mg of zoledronic acid, over ten percent had instances of bone fracture. Of the 8 mg group, more men suffered fractures.
The average survival time and progression of the disease weren’t different in the various groups studied. Their assessment of their own quality of life did not differ much, either. There were flu like symptoms more prevalent in the groups treated with zoledronic acid than those on a placebo.
