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What next when focal therapy for prostate cancer is not enough?

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Focal therapies are experimental treatments for localised prostate cancer. Focal therapies destroy small tumours, preserving some of the prostate gland. The aim is to treat the cancer with less side effects than surgery or radiotherapy. But what happens if prostate cancer comes back after focal therapy? Will the focal therapy make subsequent treatment more difficult?

Focal therapies for prostate cancer

Focal therapies are treatments for localised prostate cancer that are currently being developed and tested. Focal therapies aim to treat the cancerous part of the prostate, without destroying the whole gland. It’s hoped that leaving some of the gland intact will reduce the side effects, compared to radiotherapy or surgery.

A focal therapy is most suitable for a cancer that has one “focus of origin”. These cancers have one specific region of the prostate from which cancer cells are growing. Most prostate cancers are not focal, so the focal therapy won’t be ideal for these.

There are numerous different types of focal therapy. These include cryotherapy, focal high-intensity focussed ultrasound (HIFU), laser ablation, photodynamic therapy, Nanoknife, focal brachytherapy and radiofrequency ablation. Some of these are available in Australia. Focal therapies are described in a research blog from 2016.

Focal therapy research

Focal therapies are generally considered experimental. As these treatments are relatively new, we have limited knowledge on how effective they are. Initial case series studies indicate that focal therapies are relatively safe and often lead to a reduction in PSA levels. But there remains a risk of side effects, such as incontinence and erection problems. Case series track the progress of patients after treatment, but don’t make any comparisons to men who have different treatments or active surveillance.

There are ongoing trials asking whether having a focal therapy improves survival and whether the side effects are less than from surgery or radiotherapy. One high-quality clinical trial demonstrates the benefits of a focal therapy called TOOKAD. TOOKAD is a photodynamic therapy. It involves injection into the vein with a drug that is activated by light. A laser probe is inserted into the prostate, guided by ultrasound, in a similar manner to biopsy needles. The drug is activated by light in the prostate region, killing cells in the gland. Unfortunately, TOOKAD therapy is not yet available in Australia.

How often do focal therapies fail?

The focus of these week’s blog is what happens when focal therapies fail? In other words, how should prostate cancer be managed for a man who has had a focal therapy, but the cancer has come back. This was a topic of discussion at the recent EAU meeting.

Since focal therapies are relatively new, there are no best practice guidelines for following-up on patients after treatment. PSA levels, prostate biopsy and MRIs are commonly used to test the success of the therapy going forward. One expert committee has suggested that a biopsy done 1 year after treatment should be a standard gauge of success for focal therapies.

How often do focal therapies fail to stop prostate cancer growth? There is no simple answer to this question. There are numerous types of focal therapy, used by men with varying different stages and grades of prostate cancer. Studies that test the success of focal therapies have not been going for long enough to ask whether they saves lives or prevent progression to metastatic disease. One systematic review found that up to 17% of men treated with a focal therapy had a clinically significant prostate cancer detected by biopsy after the focal therapy. A study of focal HIFU (available in Australia) showed that about 14.3% of men had signs of prostate cancer from biopsies or MRIs after the HIFU treatment. Most of the men in this study (83.9% of them) had intermediate-risk prostate cancer.

A recent position piece by the European Association of Urology estimates that focal therapies fail to stop prostate cancer for between 3.6% to 40% of men who have them. Obviously a lot more research is needed before we can predict the success rates of each focal therapy, for men with specific stages and grades of prostate cancer. So this lack of data makes it difficult for doctors to predict how successful a focal therapy will be for their patients.

Treatment options after failure of focal therapy

At the recent EAU meeting in Barcelona, focal therapy for men with intermediate-risk prostate cancer was discussed in a dedicated session. Prof Roman Ganzer from Asklepios Hospital in Germany presented on the topic of what to do after a first focal therapy treatment fails to control prostate cancer.

Possible options after focal therapy has failed include active surveillance, retreatment with the same focal therapy, treatment with a different focal therapy, radiotherapy or surgery. Second treatments after a failed first treatment are called salvage treatments. So these would be referred to by doctors as salvage radiotherapy or salvage radical prostatectomy (prostate surgery).

A very important consideration is how will the first focal therapy affect the subsequent treatment? For example, we know that initial radiotherapy to the prostate gland makes subsequent surgery more difficult. Surgery after external beam radiotherapy (EBRT) has a good success rate, but there is a considerable risk of difficult side effects. What we need to know, is whether focal therapies make salvage radiotherapy or surgery problematic. What if the focal therapy is actually increasing the risk of failure of the second treatment, or the risk of problematic side effects?

This area of research is in its early days. But there are some preliminary results that are worth noting. One study examined a redo of HIFU after failure. The retreatment with HIFU seemed to be associated with increased urine leakage and worsening of erection problems. But this early study needs confirming with larger trials before we can be sure.

Another study examined success and side effects for men having surgery after failure of focal therapy. Researchers from Brazil compared 22 men who had focal therapy then surgery, to 44 men who just had surgery, for the same stage of localised prostate cancer. Surgery after focal therapy was considered feasible. The rates of surgical complications were the same, despite previous focal therapy for one group. The rates of incontinence after surgery were also similar between the two groups. Unfortunately the men having surgery after focal therapy had poorer outcomes for erections and potency. These preliminary results need the be assessed in a larger clinical trial for confirmation.

Another recent publication has reports on the success and side effects of surgery after treatment with TOOKAD, a photodynamic therapy. The researchers assessed records for 313 men who had TOOKAD treatment. They found that 19% (45 men) needed surgery due to their cancer returning. There was no control group in this study; it was a case series. The study examined outcomes for patients in 14 different surgical centres in Europe, following-up at least 1 year after surgery.

The study showed that for men having salvage prostate surgery:

  • According to the surgeons the surgery was “easy” in 69% of cases and “difficult” in 13%.
  • Nerve-sparing operations were possible in 33% of cases.
  • 31% of patients had a positive surgical margin, indicating that some cancer was left behind after the surgery.
  • In 88% of patients, PSA levels were undetectable for the first year.
  • After 1 year, 64% of these men needed no pads and 24% had low-level incontinence.
  • 11% of these men recovered erections without needing treatment, whereas 64% could achieve erections if they had treatments to help them.

The researchers concluded that prostate surgery after TOOKAD was feasible and relatively safe for most of the surgeons involved.

 

There is ever-increasing interest in focal therapies for men with localised prostate cancer. As described in last week’s blog, many websites describing focal therapies have inaccurate information. Therefore, the best source of information about focal therapies is doctors. It may seem frustrating that doctors cannot give very specific answers at this stage. The medical profession work from evidence, and the evidence describing the benefits and the risks of focal therapies for prostate cancer remains limited, as trials are ongoing. However, it’s encouraging to note that preliminary results indicate salvage treatments such as surgery are feasible options for when focal therapies fail to control prostate cancer.

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