Answer: The main side effect is impotence, but only in about 6% compared to 3% on placebo. That is to be expected with men of that age who are followed for a long time. Some men will for one cause or another will report impotence – that’s just the natural history of aging. No other significant side effects have been reported, either biochemical or subjectively perceived. This has been very thoroughly studied under the Good Clinical Practice international rules – any disorder that any subject has during the study period is registered, even if it’s unrelated to the drug. In our trial, 40% of the men already reported sexual dysfunction at the start of the trial, and we estimated that we might have had over-reporting of impotence because it was listed in the patient information as a possible side effect. When you alert the patients to anticipate a side effect, it is more frequently reported because they’re watching for it and they’re going to attribute it to the medication. We have data now for six years of treatment, which hasn’t altered the picture – the side effects have not increased or changed. The patients who have had a good response find that efficacy is maintained over that time – tolerance has not developed.

Answer: This comes down to the question of who is a good responder, and what is a good response. Is it complete abolition of symptoms or just a 50% improvement, enough to make the patient feel just like a normal elderly man? The degree of prostate gland enlargement is the key factor that predicts outcome of treatment. We performed a meta-analysis, pooling the results from similar trials, so we now have data from over 4,000 patients. This analysis clearly showed that men with more enlarged prostates, over 40 g, have a more significant benefit from the drug. The mean size of the prostates in our study was about 41 g, meaning half the men had prostates larger than that, and half smaller. In our estimation, about 40% of patients have the best effect from the drug, significantly better than reported in the trial. About 20% dropped out over the two years of the study, and the main reason was lack of expected efficacy. If you use the principle “intention to treat”, which means including results from every patient initially enrolled in a study, you get a true picture of what happens to the whole population you treat. It actually diminishes the end results, but it’s regarded as state of the art statistics. The intention is to see in a large group of patients what happens to the whole group, whether they stay in the trial or drop out.

Answer: It’s not only benign prostatic hyperplasia (BPH) patients. This is seen with many chronic benign disorders, for example asthma or incontinence. When you first see the patient, they are always worried that it could be something more serious. The patient is reassured by the doctor, and just the fact that they are being checked by a health professional brings some subjective improvement because it alleviates stress and anxiety, which can make any symptom seem worse. The other factor is that if you don’t treat BPH at all, the disease fluctuates naturally — there are good and bad periods, but over the long term it has an overall worsening. It never gets better all by itself. The patient always goes to the doctor when the symptoms are at their worst, and if you have a seasonal variation, whatever you do over the next two or three months the symptoms will seem to improve because of the natural cycle. That’s why we had a two-year trial, to try to eliminate the possible bias caused by the natural fluctuation.

Answer: The metabolite dihydrotestosterone (DHT) is the active hormone inside prostate cells, and it influences the protein synthesis within the cells. This means that the prostate must have a certain level of DHT within its cells to stimulate and maintain protein synthesis. If you lower the level of DHT inside the prostate cells, you stop or maybe even reverse the growth, since the presence of DHT is a prerequisite for the continuous growth of the gland.

Answer: That is only partly understood. One known factor is aging and the other is presence of the male sex hormone testosterone. The presence of functioning testes are a prerequisite for prostate enlargement. This has been known for decades because of reports from countries where, for religious or other reasons, castration is performed on men at a young age – these men never develop BPH. There might be dietary factors, but this has been looked at globally, and no clear factors that provoke BPH have been found as yet. It’s very difficult to ascertain the global rates of benign prostatic hyperplasia. No countries have an especially low incidence, but there are many potentially confounding factors. Many Third World countries do not have registries of various diseases, so of course they’d under-report — and if people don’t have good access to health care, then the disease is never diagnosed or registered.

There are factors that have been investigated and found not to predispose to BPH: smoking, alcohol consumption and even sex.

Prostate Specific Antigen (PSA) is blood test that is elevated in prostate cancer, benign prostate hypertrophy, prostate trauma, prostate infection, after prostate examination or ejaculation. Liver enzymes in blood can be elevated in many medical conditions. Some examples include viral hepatitis, medication effects, alcoholic liver damage, gallstone disease, cancer in the liver, excessive fat or iron in the liver etc. Therefore it is difficult to directly answer your question regarding relationship between elevated PSA and liver enzymes without more information.

Alkaline phosphatase is a liver enzyme that is also found in bone. Alkaline phosphatase can be elevated in liver disease and in bone diseases such as bone cancer and Paget’s disease of bone. In patients with prostate cancer that have spread to bone, both Prostate Specific Antigen (PSA) and Alkaline phosphatase can be elevated.

Thank you for your question!

Answer: Calcifications within the prostate gland are benign (not harmful) and a common finding. They are frequently detected with x-ray or ultrasound testing, even in the absence of any apparent disease process. Prostatic calculi are common, being reported in approximately 30% of adult males examined using these tests.

They occasionally are found in patients with a history of inflammation of the prostate gland (prostatitis). Larger calcifications (calculi) are commonly associated with benign enlargement of the prostate (benign prostatic hypertrophy).