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Intermittent Hormone Therapy Prostate Cancer

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What Is Advanced Prostate Cancer

Intermittent Hormone Therapy for Prostate Cancer 101 | Ask a Prostate Expert, Mark Scholz, MD

When prostate cancer spreads beyond the prostate or returns after treatment, it is often called advanced prostate cancer.

Prostate cancer is often grouped into four stages, with stages III and IV being more advanced prostate cancer.

  • Early Stage | Stages I & II: The tumor has not spread beyond the prostate.
  • Locally Advanced | Stage III: Cancer has spread outside the prostate but only to nearby tissues.
  • Advanced | Stage IV: Cancer has spread outside the prostate to other parts such as the lymph nodes, bones, liver or lungs.

When an early stage prostate cancer is found, it may be treated or placed on surveillance . Advanced prostate cancer is not curable, but there are many ways to treat it. Treatment can help slow advanced prostate cancer progression.

There are several types of advanced prostate cancer, including:

Biochemical Recurrence

With biochemical recurrence, the prostate-specific antigen level has risen after treatment using surgery or radiation, with no other sign of cancer.

Castration-Resistant Prostate Cancer

Non-Metastatic Castration-Resistant Prostate Cancer

Prostate cancer that no longer responds to hormone treatment and is only found in the prostate. This is found by a rise in the PSA level, while the testosterone level stays low. Imaging tests do not show signs the cancer has spread.

Metastatic Prostate Cancer

  • Other organs, such as liver or lungs

Metastatic Hormone-Sensitive Prostate Cancer

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Checking Your Hormone Therapy Is Working

Youll have regular blood tests to check the level of a protein called prostate specific antigen . PSA is a protein made by both normal and cancerous prostate cells. It is in the blood in small amounts in all men, unless they have had their prostate gland completely removed.

While the hormone therapy is working, the level of PSA should stay stable or may go down. But if prostate cancer cells are starting to grow and develop, the level of PSA may go up. Then your doctor may need to change your treatment. They will discuss this with you.

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Hormonal Therapy With Radiotherapy

Hormonal therapy is often used to treat early and locally advanced prostate cancer. If you have low-risk early prostate cancer you do not usually need hormonal therapy.

Doctors often advise having hormonal therapy with radiotherapy , to make your treatment more effective. You may have hormonal therapy before, during and after radiotherapy. It can be given:

  • a few months before radiotherapy, to shrink the cancer
  • after radiotherapy, to reduce the chance of the cancer coming back .

Your doctor will talk to you about how long you take hormonal therapy for. They will also explain the possible side effects.

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Intermittent Hormonal Therapy Proves To Be Viable In Prostate Cancer

With no significant difference between intermittent and continuous androgen-deprivation therapy, patients with prostate cancer may experience an improvement in their quality of life with the former.

Androgen-deprivation therapy may be an effective treatment in prostate cancer, though its side effects may result in a loss of quality of life for patients. Allowing low-risk patients to take breaks between treatmentsa practice known as intermittent hormonal therapy, or a hormone holidaymay combat these challenges without impacting survival.

“Intermittent hormonal therapy has been growing in popularity over the years. Patients who receive hormone therapy often have side effects, and giving them so-called ‘hormone holidays’ may improve quality of life. Over the years, there has really been a lot of trials and experimental work that laid the groundwork for this going back 20 years,” said Leonard G. Gomella, MD, in an interview with Targeted Oncology.

“Very recently, several big clinical trials have basically shown that, in general, patients who receive intermittent hormonal therapy have the same cancer-specific and overall survival as patients who receive continuous hormonal therapy. Patients can take a ‘hormone holiday’ and perhaps improve their quality of life and, along the way, also save some money.”

“That is now going to become the standard of care for patients with metastatic disease. We may need to investigate that.”

Are There Side Effects With Hormone Therapy

CME

Yes, there are side effects or unwanted changes in your body caused by hormone therapy. Side effects are different from person to person, and may be different from one treatment to the next. Some people have no or very mild side effects. The good news is that there are ways to deal with most of the side effects. The side effects that you have depend on:

The side effects you have from hormone therapy may be acute or chronic. Acute side effects are sometimes called “early side effects.” These types of side effects happen soon after the treatment begins and usually go away after you finish your hormone therapy. Other side effects are called chronic side effects or “late side effects.” These side effects may happen several months after you start hormone therapy.

In order to reduce your chance of having side effects, your doctor may give you intermittent hormone therapy. If you are on intermittent hormone therapy, your doctor and health care team will carefully watch your PSA level. As it begins to go up, you are given hormone therapy medicine to lower your PSA. Another way for you to get intermittent hormone therapy is to take a medicine for a set period of time and then stop for a set period of time. For example, you may take a medicine for six months, stop for six months, and then start again for six months.

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Analysis Of Iadt Mathematical Models

Here we consider only IAD models due to current clinical interest. Each model is presented and justified in a biological and mathematical sense in the original paper where the model was first presented, and we refer the reader to that papers for detailed model derivations. Similarly, the sensitivity analysis of the model parameters is presented in each paper individually, and we elaborate on it here only where necessary. We will refer to the relapsing patient set as \-set and not relapsing to as relapse \-set.

We parametrize the individual IAD data with a patient-specific control function \ defined as follows: \ = \sum\nolimits_^ }_ }} } \left\), \Footnote 1 with \ and \ minimum and maximum patient-specific treatment under consideration and \ generally after the first treatment drop \ is the number of intervals \ considered. \ is referred to as the ith treatment cycle, and \ is the indicator functionFootnote 2 for the interval \ for \, 0 otherwise). For modeling purposes, the weights/errors, \ for each data \, have been assigned either uniformly \ or with a linear decreasing relevance from the last PSA concentration \ peak, say \ of Fig. 1) with \, i.e. at \, and \ for \. Finally, we performed sensitivity analysis on all the models included here. Comments on the technique adopted are technical and left to Supplement A.

Assessment Of Selected Studies And Data Collection Process

Title and abstract from all the retrieved studies were evaluated. For every study that fulfilled the inclusion criteria, the complete article were retrieved, assessed and included or excluded according to the pre-mentioned criteria. Data were either collected directly from the text or calculated from the published information. A total of 121 references were identified and assessed. From them, 44 were selected and full-article was retrieved for evaluation. Seven randomized multicenter phase III trials were identified and included in the review. These seven studies enrolled and randomized 4675 patients to continuous versus intermittent androgen deprivation therapy, publishing extensive data and results. Hence, another 3 randomized trials . Eur Urol Suppl 2003 2: 24.-1717 . Verhagen PC, Wissenburg LD, Wildhagen MF: Quality of life effects of intermittent and continuous hormonal therapy by cyproterone acetate for metastatic prostate cancer. Eur Urol Suppl. 2008 7: 206.) were retrieved from the reference list of the retrieved articles but they lack of sufficient published data.

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How Can I Lower My Testosterone With Surgery

The majority of the testosterone in your body is made by your testicles. You can lower your testosterone with an operation called an orchiectomy. An orchiectomy is a simple and effective way to lower the amount of testosterone in your body. However, it is a permanent form of hormone therapy.

Your surgery

Some men are concerned about how their body will look after their testicles are removed. There are testicular prostheses , or artificial testicles, that can be placed in your scrotum to replace the testicles removed during your surgery. The prostheses make your scrotum look like it did before surgery. If youare concerned about how your body will look, speak with your doctor or health care team about artificial testicles.

After surgery

Your scrotum may feel a little bit sore and may be swollen. You will be given medicines to relieve the soreness. You may use ice packs for the first day or two after your orchiectomy to help with the swelling. Remember, do not put the ice pack directly on your scrotum. Put a towel or piece of clothing over your scrotum, then place the ice pack on top of it. You will need to keep your incision clean and dry. Your doctor and health care team will tell you how to clean your incision. You will need to avoid heavy lifting or hard activity for one to two weeks following your surgery.

Follow-up tests

Possible side effects

More hormone treatment

What Is The Basis For The Theory That Intermittent Hormonal Therapy Could Delay The Development Of Castration

Intermittent Hormone Therapy: PSA and Hormone Replacement | Ask a Prostate Expert, Mark Scholz, MD

In addition, there has also always been a theoretical idea that intermittent hormonal therapy could potentially delay the development of castration-resistant prostate cancer.It encourages the prostate cancer to have more dependence on hormonal manipulation. When the testosterone levels are high, it encourages the development and growth of cells, which are androgen-dependent. When the hormone levels are low, it encourages the growth of cells that are androgen-independent.

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What Is Hormonal Therapy For Prostate Cancer

Hormonal therapy for prostate cancer is a treatment to lower the levels of the hormone testosterone in the body. Prostate cancer needs testosterone to grow. Testosterone is mainly made by the testicles. Hormonal therapies reduce the amount of testosterone in the body, or stop it reaching the prostate cancer cells.

Testosterone is important for:

  • muscle development and bone strength.

Hormonal therapies are drugs that can be given as injections or as tablets.

Male Hormones And Prostate Cancer

Androgens are male sex hormones. Testosterone is one main type of androgen. Most testosterone is made by the testicles. The adrenal glands also produce a small amount.

Androgens cause prostate cancer cells to grow. Hormone therapy for prostate cancer lowers the effect level of androgens in the body. It can do this by:

  • Stopping the testicles from making androgens using surgery or medicines
  • Blocking the action of androgens in the body
  • Stopping the body from making androgens

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Hormone Therapy With Radiotherapy

You have this if:

  • your cancer hasnt spread to other parts of the body but is at a high risk of coming back, eg the cancer has grown through the covering of your prostate
  • you have a very high prostatic specific antigen level
  • you have a high Gleason score

You might have hormone therapy before, during and after radiotherapy. Doctors usually recommend that you have the treatment for between 3 months and 3 years. How long depends on the risk of your cancer coming back and how many side effects you get.

Intermittent Hormonal Therapy For Locally Advanced Prostate Cancer

A 10

Intermittent hormonal therapy is where you stop taking the drugs and after a while start taking them again. This may be an option for locally-advanced prostate cancer. It gives you a break from the side effects of hormonal therapy.

Intermittent hormonal therapy is not suitable for everyone and should only be done on your doctors advice. Your doctor can explain more about this. They usually measure your PSA level using the PSA test every 3 months. If it goes up to a certain level or you get symptoms, your doctor will advise you to start hormonal therapy again.

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How Might I Feel During Hormone Therapy

Nearly all men being treated for prostate cancer say that they feel emotionally upset at different times during their hormone therapy. It’s not unusual to feel anxious, depressed, afraid, angry, frustrated, alone, or helpless. Hormone therapy may affect your emotions because it lowers the amount of testosterone in your body.

Some men find it helps to learn about their disease and treatment because it makes them less afraid of their treatment. Find out as much as you want to know. Do not be afraid to ask questions. Your emotional health is as important as your physical health.

Talking with an understanding friend, relative, minister or another patient may be helpful. Your doctors office may be able to give you a list of local prostate cancer support groups. There will be men in the support groups who have had hormone therapy. You may also contact the American Cancer Society at 1-800-227-2345 or the National Cancer Institutes Cancer Information Line at 1-800-422-6237 to find out about cancer resources in your local community.

Many people don’t understand prostate cancer or its treatment. They may stay away from you because they’re not sure what to say or how to help. Try to be open when you talk to other people about your illness, treatment, needs, and feelings. People will often be willing to lend their support. If you get tired easily, limit your activities and do only the things that mean the most to you.

Apalutamide Plus Intermittent Hormone Therapy Versus Intermittent Hormone Therapy Alone In Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02811809
Recruitment Status : Withdrawn First Posted : June 23, 2016Last Update Posted : February 27, 2020

Apalutamide is an investigational drug, which means it has not been approved by the Food and Drug Administration . It is an antitumor drug, taken by mouth. The purpose of this study is to determine the ability of Apalutamide to extend the time between the first two injections of leuprolide and improve quality of life. This study will also look at the safety of Apalutamide and the effects that Apalutamide has on prostate cancer.

Men will be randomized to receive:

  • Group A: Leuprolide + Apalutamide or
  • Group B: Leuprolide only , then leuprolide + Apalutamide 45 men will be in Group A and 21 men will be in Group B. Leuprolide is given as an intramuscular shot that lasts for 3 months intermittently and Apalutamide is taken by mouth daily. Each cycle is 4 weeks long.

Intermittent treatment with Apalutamide + leuprolide will continue until continuous leuprolide is needed to maintain undetectable PSA levels .

Condition or disease
Phase 2
  • Current evidence of any of the following:

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    What Is Hormone Therapy For Cancer

    Also referred to as hormonal or endocrine therapy, this cancer treatment is different from menopausal hormone replacement therapy , which refers to the prescription of supplemental hormones to help relieve the symptoms of menopause.

    Certain cancers rely on hormones to grow. In these cases, hormone therapy may slow or stop their spread by blocking the bodys ability to produce these particular hormones or changing how hormone receptors behave in the body.

    Breast and prostate cancers are the two types most commonly treated with hormone therapy. Most breast cancers have either estrogen or progesterone receptors, or both, which means they need these hormones to grow and spread. By contrast, prostate cancer needs testosterone and other male sex hormones, such as dihydrotestosterone , to grow and spread. Hormone therapy may help make these hormones less available to growing cancer cells.

    Hormone therapy is available via pills, injection or surgery that removes hormone-producing organs, namely the ovaries in women and the testicles in men. Its typically recommended along with other cancer treatments.

    If hormone therapy is part of your treatment plan, discuss potential risks or side effects with your care team so that you know what to expect and can take steps to reduce them. Let doctors know about all your other medications to avoid interactions.

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    Treatment To Lower Androgen Levels From Other Parts Of The Body

    Taking Testosterone During Intermittent Hormone Therapy | Mark Moyad, MD, MPH & Mark Scholz, MD

    LHRH agonists and antagonists can stop the testicles from making androgens, but cells in other parts of the body, such as the adrenal glands, and prostate cancer cells themselves, can still make male hormones, which can fuel cancer growth. Some drugs can block the formation of androgens made by these cells.

    Abiraterone blocks an enzyme called CYP17, which helps stop these cells from making androgens.

    Abiraterone can be used in men with advanced prostate cancer that is either:

    • Castration-resistant

    This drug is taken as pills every day. It doesnt stop the testicles from making testosterone, so men who havent had an orchiectomy need to continue treatment with an LHRH agonist or antagonist. Because abiraterone also lowers the level of some other hormones in the body, prednisone needs to be taken during treatment as well to avoid certain side effects.

    Ketoconazole , first used for treating fungal infections, also blocks production of androgens made in the adrenal glands, much like abiraterone. It’s most often used to treat men just diagnosed with advanced prostate cancer who have a lot of cancer in the body, as it offers a quick way to lower testosterone levels. It can also be tried if other forms of hormone therapy are no longer working.

    Ketoconazole also can block the production of cortisol, an important steroid hormone in the body, so men treated with this drug often need to take a corticosteroid .

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