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Hormone Therapy For Advanced Prostate Cancer

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Evidence For Hormone Therapy For Prostate Cancer

Hormone Therapy & Advanced Therapies for Prostate Cancer, Celestia Higano, MD | 2021 Mid-Year Update

The addition of radiation therapy to hormone therapy for the treatment of locally advanced prostate cancer reduces prostate cancer deaths by 50%, according to the results of a Scandinavian study published in the Lancet.

In 1996 researchers from the Scandinavian Prostate Cancer Group and the Swedish Association for Urological Oncology initiated a Phase III trial to evaluate the benefits of adding radiation to hormone therapy. The trial involved 875 patients who were randomized to receive either hormone therapy alone or combined hormone/radiation therapy . After nearly eight years of follow-up, 79 men in the hormone-only group had died of prostate cancer compared with 37 in the combination group. Furthermore, the rate of recurrence was substantially higher in the hormone-only group: 74.7% versus 25.9% in the combination group. After five years urinary, rectal, and sexual problems were slightly more frequent in the combination group.

The researchers concluded that the combination of radiation therapy and hormone therapy was superior to hormone therapy alone and cut the rate of prostate cancer deaths in half. Furthermore, the side-effect profile for the combination therapy was acceptable.

The Birmingham Prostate Clinic is a centre of excellence for external beam radiotherapy and we would be happy to discuss your needs and treatment options with you.

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Advances In Hormonal Therapy: From Clinical Trials To Clinical Practice

Metastatic prostate cancer ultimately becomes unresponsive to the standard androgen deprivation therapy presently available. A huge amount of research is being carried out to develop new therapeutic agents that can slow the progression of hormone-resistant prostate cancer . The introduction of new androgen affecting pathways in recent clinical trials demonstrated improved survival in this setting.

The biosynthesis of the testosterone precursors dehydroepiandrosterone and androstenedione are mediated by the CYP17 enzyme. Since inhibition of this enzyme is a critical step in the prevention of biosynthesis of androgens, CYP17 inhibitors are the newest agents in the hormonal therapy for prostate cancer.93 Although ketoconazole is the first drug to be used as CYP17 inhibitor, it is non-specific and has a higher side-effect profile.94 Due to selective and irreversible inhibition of the CYP17 enzyme by abiraterone acetate, this drug had significant effects in phase I/II clinical trials against prostate cancer.95-97

In addition, a phase III clinical trial was recently conducted to explore the role of abiraterone acetate in 1088 HRPC patients who had not been previously treated with docetaxel. The results demonstrated that abiraterone acetate produced a significant improvement in OS, progression-free survival, and time to chemotherapy initiation.99

How Long Does Hormone Therapy Work To Stop Cancer Progression

On average, hormone therapy can stop cancer progression for 1-2 years before the prostate cancer becomes resistant. Hormone therapy can stop working over time as the prostate cancer begins to grow again .

When this occurs, doctors may offer other therapies. Since they cant predict how long hormone therapy will work, they may perform regular blood tests to check PSA and testosterone levels. If PSA levels start to increase and testosterone levels are low, these may be signs that the cancer has started to grow again.

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The Future Of Hormone Therapy For Prostate Cancer

Some experts arent sure how much further we can improve hormone therapy for prostate cancer.

Im not saying that weve reached the end of what we can do with hormonal therapy, Thrasher tells WebMD, but there are only so many ways to shut down the hormonal effects. The cancer will still eventually escape.

Brooks argues that, overall, prostate cancer is only moderately affected by hormones. You can only do so much manipulating the levels of hormones, says Brooks. We have to find better ways to fight the basis of the cancer cells.

Thrasher and Brooks have more hope that the next breakthroughs will come with different approaches, like chemotherapy or vaccines.

But Holden remains optimistic about the future of hormone therapy for prostate cancer.

Cancer cells eventually figure out how to survive, how to overcome a specific hormone therapy, he says. But if we have enough types of drugs and can keep changing the hormone therapy, we might be able to keep the cancer cells in a state of confusion. We could change therapies before they have a chance to adapt.

Its like an endless chess game, he says. You may not ever win, but you might be able to prolong the game indefinitely. I think that hormone therapy still has a lot of promise. We just need to develop better anti-androgens, and more varieties of them.

Surgically Removing The Prostate Gland

Treating Locally Advanced Prostate Cancer

A radical prostatectomy is the surgical removal of your prostate gland. This treatment is an option for curing prostate cancer that has not spread beyond the prostate or has not spread very far.

Like any operation, this surgery carries some risks.

A recent trial showed possible long-term side effects of radical prostatectomy may include an inability to get an erection and urinary incontinence.

Before having any treatment, 67% of men said they could get erections firm enough for intercourse.

When the men who had a radical prostatectomy were asked again after 6 months, this had decreased to 12%. When asked again after 6 years, it had slightly improved to 17%.

For urinary incontinence, 1% of men said they used absorbent pads before having any treatment.

When the men who had a radical prostatectomy were asked again after 6 months, this had increased to 46%. After 6 years, this had improved to 17%.

Out of the men who were actively monitored instead, 4% were using absorbent pads at 6 months and 8% after 6 years.

In extremely rare cases, problems arising after surgery can be fatal.

Its possible that prostate cancer can come back again after treatment. Your doctor should be able to explain the risk of your cancer coming back after treatment, based on things like your PSA level and the stage of your cancer.

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Treating Advanced Prostate Cancer

If the cancer has reached an advanced stage, its no longer possible to cure it. But it may be possible to slow its progression, prolong your life and relieve symptoms.

Treatment options include:

  • hormone treatment

If the cancer has spread to your bones, medicines called bisphosphonates may be used. Bisphosphonates help reduce bone pain and bone loss.

Table : Boosting The Effectiveness Of Radiation Therapy

A randomized controlled study involving 206 men with early-stage prostate cancer evaluated whether adding six months of hormone therapy to external-beam radiation treatment would boost both overall survival and disease-free survival . The results are given below. The same research group found, in an earlier study, that the addition of hormone therapy was of most benefit to men who were considered at moderate or high risk, based on their clinical profile.

Five-year follow-up 82% Source: Journal of the American Medical Association, 2004 292:8217. PMID: 15315996.

Combined with radiation therapy. A number of studies have shown that men with early-stage prostate cancer are more likely to be cured when hormone therapy is given in conjunction with radiation therapy . Even when the disease is regionally advanced, meaning that it has progressed to tissues immediately surrounding the prostate gland, neoadjuvant hormone therapy reduces risk of progression and relapse .

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Lhrh Agonist Injections Or Gnrh Antagonists

These drugs stop the release of a hormone that sends signals to the testicles to produce testosterone. It is a roundabout way of switching off testosterone and so helps to stop prostate cancer from growing.

The first injection is usually given at the hospital, but further injections can be given by your GP. The injections are repeated every month or every three months, depending on the type of hormone therapy and according to the recommendations of your doctor.

What are the risks and side effects of hormone-manipulation drug therapy?

How The Study Was Performed

Living with hormone therapy: Bruce’s story

During the study, scientists randomized 1,071 men with intermediate- or high-risk localized prostate cancer into four groups. One group received radiation and six months of an anti-testosterone drug called leuporelin, and the second group received radiation plus 18 months of leuporelin therapy. Two other groups were treated with the same regimens of either radiation plus six or 18 months of leuporelin therapy, along with another drug called zoledronic acid, which helps to limit skeletal pain and related complications should cancer spread to the bones. Study enrollment occurred between 2003 and 2007 at 23 treatment centers across New Zealand and Australia.

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Drugs That Stop The Body From Making Androgens

Androgens can be produced in other areas of the body, such as the adrenal glands. Some prostate cancer cells can also make androgens. Three drugs help to stop the body from making androgens from tissue other than the testicles.

Two medicines, ketoconazole and aminoglutethimide , treat other diseases but are sometimes used to treat prostate cancer. The third, abiraterone treats advanced prostate cancer that has spread to other places in the body.

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Biochemical Recurrence And Hormone Therapy

Hormone therapy is the standard of care for patients with metastatic prostate cancer, but for patients whose only sign of cancer recurrence is a rising PSA level , the benefits are less clear.

Some doctors think that hormone therapy works better if its started as soon as possible, even if a man is not having any symptoms. Other doctors feel that, because of the side effects of hormone therapy and the chance that the cancer could become resistant to the therapy, treatment shouldnt be started until symptoms develop. This issue is being actively studied.

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What Is Intermittent Adt

Researchers have investigated whether a technique called intermittent androgen deprivation can delay the development of hormone resistance. With intermittent androgen deprivation, hormone therapy is given in cycles with breaks between drug administrations, rather than continuously. An additional potential benefit of this approach is that the temporary break from the side effects of hormone therapy may improve a mans quality of life.

Randomized clinical trials have shown similar overall survival with continuous ADT or intermittent ADT among men with metastatic or recurrent prostate cancer, with a reduction in some side effects for intermittent ADT .

Risk Of Heart Problems

FDA Approves Relugolix for Advanced Prostate Cancer

Hormone therapy for prostate cancer might increase the risk of heart problems if you have certain medical conditions.

This may be because some of the side effects of hormone therapy, such as weight gain, can make heart disease worse.

  • Gynecomastia in Patients with Prostate Cancer: A Systematic Review

    A Fagerlund and others

  • Treatment Of Osteoporosis in Men

    UpToDate, Accessed August 2019

  • Cardiovascular effects of hormone therapy for prostate cancer

    J Lester and D Mason,

    Drug, Healthcare and Patient Safety, 2015. Volume 7

  • Cognitive Effects of Androgen Deprivation Therapy in Men With Advanced Prostate Cancer

    B Gunlusoy and others

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Pain From Tumour Flare

Pain caused by a secondary prostate cancer can temporarily worsen when you start hormone treatment. This is called tumour flare.

Your doctor should always prescribe another hormone therapy when you start leuprorelin or goserelin injections. This other hormone therapy helps to prevent tumour flare from causing bone pain. If the pain carries on, your doctor can prescribe drugs called bisphosphonates to treat it.

Role Of Combined Androgen Blockage: Still A Dilemma

The continued release of androgens may occur at low levels from adrenals despite castration therapy.67 Androgens generated from an adrenal source can be neutralized by combining one of the antiandrogens to castration and this forms the rationale for combined androgen blockage therapy. Various trials have already been conducted in the past to evaluate the efficacy of CAB and these confirmed an important survival advantage of CAB therapy.68-70

A total 8275 men, among whom 88% had metastatic disease and 12% had locally advanced prostate cancer, were included in a meta-analysis study of 27 randomized trials performed by The Prostate Cancer Trialists Collaborative Group.71 The 5-year survival rate was 25.4% with CAB and 23.6% with androgen suppression alone but the difference was not statistically significant. The results for cyproterone acetate appeared slightly unfavorable to CAB, whereas those for nilutamide and flutamide appeared slightly favorable. The analysis concluded that, in advanced prostate cancer, there was an approximately 2-3% improvement in the 5-year survival rate with the addition of the antiandrogen to androgen suppression.

A meta-analysis by Schmitt et al.72 concluded that there was an improvement in progression-free survival at one year and at 5 years, and a 5% improvement in overall survival with CAB.

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Advantages And Disadvantages Of Hormone Therapy

Advantages

  • It can control your cancer even if it has spread to other parts of your body.
  • It can be used with other treatments such as radiotherapy and make it more effective.
  • In advanced prostate cancer it can reduce bone pain and urinary symptoms.

Disadvantages

  • It can affect your quality of life due to side-effects
  • It can keep prostate cancer under control for some time but unfortunately it cant cure it.

Who Is A Candidate

Hormone Therapy for Prostate Cancer

Most men with advanced prostate cancer are candidates for hormone therapy. Its usually considered when prostate cancer has spread beyond the prostate, and surgery to remove the tumor is no longer possible.

Prior to starting treatment, youll need to have a liver function test along with a blood test to make sure your liver can break down the medications properly.

Currently, enzalutamide is only approved for use in men with prostate cancer that has already spread to other parts of the body, and who no longer respond to medical or surgical treatments to lower testosterone levels.

In some cases, prostate cancer cells can resist hormone treatments and multiply even in the absence of male hormones. This is called hormone-resistant prostate cancer. Men with hormone-resistant prostate cancer arent candidates for further hormone therapy.

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When Is Hormone Therapy Used

Hormone therapy may be used:

  • If the cancer has spread too far to be cured by surgery or radiation, or if you cant have these treatments for some other reason
  • If the cancer remains or comes back after treatment with surgery or radiation therapy
  • Along with radiation therapy as the initial treatment, if you are at higher risk of the cancer coming back after treatment
  • Before radiation to try to shrink the cancer to make treatment more effective

Hormonal Therapy On Its Own For Early And Locally Advanced Prostate Cancer

If your doctors are using the watchful waiting approach and the cancer starts to grow, you may have hormonal therapy on its own.

Some people with early prostate cancer decide to have hormonal therapy on its own instead of with surgery or radiotherapy. Some people with locally advanced cancer decide to have hormonal therapy on its own instead of radiotherapy. Unlike these treatments, hormonal therapy on its own will not get rid of all the cancer cells. Doctors do not usually advise this. But it may be suitable if you:

  • are not well enough to have surgery or radiotherapy
  • do not want these treatments.

Hormonal therapy can slow down or stop the cancer cells growing for many years. Not having surgery or radiotherapy means you avoid the side effects of these treatments. Hormonal therapy can also cause side effects . It is important to talk to your doctor or nurse about it before you decide.

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Definitions That May Help

Your doctor may use specific terms to let you know how your cancer is responding to hormone therapy or other treatments. They include:

  • Castrate level: When the testicles are removed and testosterone levels plummet, this is referred to as the castrate level. Androgen levels that remain this low are most beneficial for reducing the impact of prostate cancer. Hormone therapy is designed to keep testosterone at castrate level.
  • Castrate-sensitive prostate cancer : CSPC refers to prostate cancer that is being controlled successfully with testosterone at castrate level.
  • Castrate-resistant prostate cancer : CRPC prostate cancer refers to cancer that is not successfully controlled, even though testosterone levels are at or below castrate level. CRPC may require additional medications, such as a CYP-17 inhibitor or one of the newer antiandrogens.
  • Hormone-refractory prostate cancer : HRPC is prostate cancer that is no longer responsive to any type of hormone therapy, including newer medications.

Systemic Therapy For Metastatic Disease

Hormone Therapy for Prostate Cancer

The most common use of hormone therapy today is to treat men whose prostate cancer has metastasized to other parts of the body. If prostate cancer cells escape the prostate, they migrate first to surrounding structures, such as the seminal vesicles and lymph nodes, and later to the bones or, rarely, to other soft tissues.

Hormone therapy is recommended as a palliative treatment, to relieve symptoms such as bone pain. And while hormone therapy is not a cure, in that it cant eliminate prostate cancer completely, it often extends life for many years. By reducing testosterone levels, hormone therapy can shrink a prostate tumor and its metastases and slow further progression of the cancer for so long that sometimes a man with this disease dies of something other than prostate cancer.

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Life Expectancy And Localized Prostate Cancer

So how do these treatments affect life expectancy? In one study, researchers in Switzerland examined the treatment and outcomes of 844 men diagnosed with localized prostate cancer. They compared men who had been treated with prostatectomy, radiotherapy and watchful waiting and found that at five years from diagnosis, the type of treatment made little difference to survival. When the researchers went to 10 years from diagnosis, they did find a difference in survival based on treatment, but it was fairly small.

After 10 years, 83 percent of the men who had gotten a prostatectomy were still living, compared to 75 percent who had undergone radiotherapy and 72 percent who took a watchful waiting approach.

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