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PSA testing for men who have had treatment for an enlarged prostate.

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A non-cancerous, enlarged prostate can be treated with drugs to reduce symptoms. Drugs called 5-alpha reductase inhibitors (5-ARIs) reduce PSA levels for these men. This could be problematic, as it could hide the PSA increase caused by a small prostate tumour. Results from a new study in California have suggested that PSA suppression in 5-ARI users was not routinely accounted for during prostate cancer testing, leading to delays in prostate cancer diagnosis and worse outcomes.

Benign prostatic hyperplasia (BPH)

Benign prostatic hyperplasia (BPH) is a condition that leads to prostate enlargement. It’s not the same as prostate cancer. BPH is a non-cancerous growth of the prostate gland. BPH is extremely common. It’s estimated that BPH is present in half of all men over 50 years of age. But many of these men do not realise that they have it. Symptoms of BPH include frequent need to urinate, difficulty starting and ending urination and incomplete emptying of the bladder. These symptoms, in men, can also result from conditions such as prostate cancer or infections. It’s best to visit your GP if you have some of these symptoms.

Treatment of BPH

BPH can be treated by surgery or drugs. There are two types of drug therapies commonly used to treat BPH. Alpha-blockers are drugs that “relax” some types of muscle. They help to relieve tension from muscles around the prostate and bladder. This improves urine flow. But there is a risk of side effects, such as problems with erections and ejaculation, nasal congestion, low blood pressure, dizziness and increased heart rate.

BPH can also be treated with drugs called 5-alpha reductase inhibitors (5-ARIs). This class of drug acts to reduce the effects of male hormones. 5-ARIs stop the conversion of testosterone into a more potent hormone call di-hydro-testosterone. The drugs Finasteride (Proscar) and Dutasteride (Avodart) are 5-ARIs. They are used for limited periods of time to reduce prostate size and relieve symptoms of BPH. These drugs bring a risk of erection problems, decreased libido, decreased ejaculate and decreased sperm count.

The drug Finasteride is used for two reasons in Australia. Low levels of Finasteride are used to treat hair loss. In this form, the drug is called Propecia. Higher concentrations are used to treat BPH. Another potential use of Finasteride is in the prevention of prostate cancer. But this is not done in Australia, and there is a warning from the American FDA about its use. As described in a previous blog, men who took Finasteride for 7 years had a reduced chance of being diagnosed with prostate cancer. But the side effects from this drug, as well as an increased risk of diagnosis with higher-grade prostate tumours, has led the FDA to recommend against its long-term use to prevent prostate cancer.

What do PSA levels tell us about the prostate?

The best early warning for the presence of prostate cancer is PSA level. PSA is measured in simple blood tests. How can PSA in the blood tell us that there is cancer in the prostate?

PSA stands for prostate-specific antigen. It’s a protein produced by prostate cells. PSA is excreted by the prostate gland and is an important part of semen. It’s responsible for making semen clumpy. Aside from being part of the semen, a small amount of PSA enters the blood stream. When a prostate gland grows in size, it naturally produces more PSA. So PSA levels can indicate how many prostate cells are present in the body.

How and why does the prostate grow? Prostate glands often gradually grow during a man’s life. So PSA levels may gradually rise over the years. This is not a problem. But abnormal prostate growth can be problematic. An enlarged prostate can be caused by BPH. This type of growth comes from abnormal prostate cells, but not ones that are cancerous. BPH can disrupt the urine flow, so treatment is often needed. Prostate cancer is, or course, another abnormal form of prostate gland growth.

PSA is therefore an indictor of how many prostate cells are present in the body. During BPH, PSA levels will often rise a bit, as there are more prostate cells present in the enlarged prostate. So treating BPH with drugs that make the prostate smaller also reduces PSA levels. This is good for reducing symptoms from BPH. But there is a potential problem – what if the man also has a prostate tumour? Can reducing PSA levels by 5-ARI treatment hide a growing tumour that should be detected early in a PSA test?

Association of 5-ARI use and poor outcomes from prostate cancer

A new study has reported an association of 5-ARI use with a number of poor outcomes from prostate cancer. This study came from the US and used medical records from American patients. The researchers were led by Dr Reith Sarkar from the University of California.

To study the effects of treatment with 5-ARIs, the researchers used medical records from US Veterans (ex-members of the US armed forces). They accessed patient records for over 80,000 men diagnosed with prostate cancer from 2001 to 2015. These records contained details of prostate cancer diagnosis and of past use of drugs to treat BPH.

The researchers predicted that use of 5-ARIs prior to prostate cancer diagnosis could lead to poorer outcomes such as delayed diagnosis, more advanced disease at diagnosis and higher risk of death from prostate cancer. To ask if this was so, they cross-referenced 5-ARI use, diagnosis details and cause of deaths from the US National Death Index.

To be in the study, patients needed to have 2 years of medical records available before diagnosis with prostate cancer. There were 8,587 men who were prescribed 5-ARIs at least 1 year before their prostate cancer diagnosis. Most had taken Finasteride, with only 181 of them taking Dutasteride.

Their research showed that for men treated previously with 5-ARI for BPH, who were diagnosed with prostate cancer:

- They were more likely to have high-grade prostate cancer (Gleason 8 or above). Men treated with 5-ARI had a 25.2% chance of diagnosis with Gleason 8 or higher, compared to 17.0% chance for men who did not have 5-ARIs.

- They were more likely to have a higher clinical stage and tumours in their lymph nodes.

- They were more likely to have metastatic disease at diagnosis. 6.7% of diagnosed men had metastatic disease if they were treated with 5-ARI for BPH, compared to 2.9% that did not have this treatment.

- They had a higher chance of dying from prostate cancer and a higher chance of dying overall.

The researchers stated that their data “suggest that PSA suppression in 5-ARI users was not routinely accounted for during prostate cancer screening and led to delays in prostate cancer diagnosis, which in turn may have resulted in advanced disease and worsened clinical outcomes”.

Is 5-ARI use for treating BPH a cause of prostate cancer?

The researchers predict that the association between previous 5-ARI use and poor outcomes from prostate cancer is due to delayed diagnosis, due to reduced PSA levels. For men who have BPH and an undiagnosed prostate tumour, reducing PSA levels will make it more difficult to see the early rise in PSA caused by the tumour. However, their research was not able to directly test whether this is the case.

Is 5-ARI for BPH a cause of prostate cancer? Is it causing prostate cancer to occur at a late stage? It’s possible that, as well as reducing PSA levels, these drugs could also be affecting the tumour. But the researchers predict that this is not the case, for a number of reasons. Firstly, decreasing the effects of male hormones usually decreases the growth of prostate cancer. Secondly, there is evidence from clinical trials that demonstrates 5-ARI use does not increase the chances of prostate cancer or death.

This does seem very confusing. The current study showed that men with prostate cancer were more likely to die if they had previously taken 5-ARIs. But in the clinical trial mentioned above, men taking 5-ARIs for many years did not have a greater risk of death. These two studies seem to have opposite results. One reason may be that the new Californian study was not a randomised controlled trial. There were differences between the two groups of men. Men who took 5-ARIs for BPH were older on average, and more likely to have other significant health issues. These could be reasons that they were more likely to die. In fact, there are numerous studies that ask whether men taking Finasteride have a higher chance of dying from prostate cancer. The results from these studies are mixed, so this remains a question that needs answering with further research.

What does this mean for Australian men?

PSA testing is still very useful for men who have had previous treatment for BPH. This question was specifically asked during the Prostate Cancer Prevention Trial (PCPT). This analysis showed that PSA testing was effective for men who took 5-ARIs. But an adjustment to PSA levels was necessary due to the drug treatment. This study was conducted in the USA quite a few years ago. In the PCPT trial, men (regardless of 5-ARI treatment) were advised to have a biopsy if their PSA level was 4ng/ml or over. In Australia this cut-off level is 3ng/ml. So our PSA testing is already more sensitive. During the PCPT, PSA levels were doubled for men having 5-ARIs – so a PSA level of 2 was reclassified as 4, leading to a biopsy recommendation. Once this was done, then PSA testing was a sensitive early warning for prostate cancer.

These studies tell us that PSA testing is very useful for men who have had 5-ARI drugs for BPH, but this needs to be taken into account when reading the test results and recommending follow-up.

If you’ve had drug treatment for BPH (Finasteride (Proscar) or Dutasteride (Avodart)) in the past, it’s best to discuss this with your GP before having a PSA test for early detection of prostate cancer.

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