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New combination could reduce the risk of Prostate cancer.

New combination could reduce the risk of Prostate cancer.

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The effectiveness of talazoparib plus enzalutamide in treating metastatic castration-resistant prostate cancer in adult males was investigated in the TALAPRO-2 international phase 3 clinical trial.

Comparing talazoparib and enzalutamide therapy to placebo and enzalutamide therapy, a 37% lower risk of cancer progression or death was observed.

In 2023, the Food and Drug Administration (FDA) is anticipated to make a decision on the use of this combination therapy to treat men with metastatic castration-resistant prostate cancer.

Prostate cancer affects one in eight men in the United States and is the second most frequent cancer in males after skin cancer, according to the American Cancer Society.

Male hormones called androgens, such testosterone, promote the growth of prostate cancer cells. Even when blood testosterone levels are controlled, prostate cancer occasionally still progresses. Castration-resistant prostate cancer is the term for this.

Metastatic castration-resistant prostate cancer is the term used to describe a type of cancer that has migrated from the prostate gland to other bodily tissues like the lymph nodes and bones.

Treatment for metastatic castration-resistant prostate cancer has greatly advanced in recent years. Despite these advancements, cancer might recur after therapy because existing medicines only have a temporary impact.

Pfizer researchers have combined the drugs talazoparib (Talzenna) and enzalutamide to create a breakthrough treatment for metastatic castration-resistant prostate cancer (Xtandi). In the phase 3 trial of TALAPRO-2, they evaluated the effectiveness and safety of this combination medication.

Dr. Neeraj Agarwal, professor of oncology and Presidential Endowed Chair of Cancer Research at Huntsman Cancer Institute, University of Utah, and principal investigator for TALAPRO-2, delivered the trial’s findings at the 2023 ASCO Genitourinary Cancers Conference.

Why this combination therapy?

Enzalutamide is a type of hormone therapy that has been approved for the treatment of prostate cancer in males. It functions by preventing testosterone from growing prostate cancer cells. Even after they have migrated to other parts of the body, without which they cannot proliferate.

The group of cancer medications known as poly-ADP ribose polymerase (PARP) inhibitors includes talazoparib. An enzyme (protein) called PARP is present in all cells and aids in the self-healing of injured cells. The repair activity of PARP in cancer cells is blocked by PARP inhibitors, which leads to the death of the cancer cells.

The FDA has authorised the PARP inhibitor talazoparib to treat germline (inherited) HER2-negative advanced breast cancer. However, has not yet licenced it to treat prostate cancer.

When combined with medications that restrict testosterone, PARP inhibitors may be beneficial for the treatment of advanced prostate cancer, according to earlier research.

This inspired Pfizer researchers to create a combination therapy that combines the testosterone-blocking drug enzalutamide with the PARP inhibitor talazoparib.

Study

Adult men from 26 different countries who had metastatic castration-resistant prostate cancer were included in the trial in December 2017.

At random, the participants were given one of the following:

  • Enzalutamide 160 mg once daily and talazoparib 0.5 mg were given to 402 individuals.
  • Or, for 403 individuals, a placebo and enzalutamide 160 mg once daily.

The TALAPRO-2 trial’s main goal was to determine whether adding talazoparib to enzalutamide extends radiographic progression-free survival (rPFS)—the period of time patients remain cancer-free—in comparison to placebo plus enzalutamide.

To see if any study participants had defective DNA repair genes, the researchers also analysed the DNA from the cancer cells of all study participants.

Drug combo lowers cancer progression risk

The median follow-up period for the combination therapy group was 24.9 months. However, the group receiving placebo + enzalutamide experienced a median follow-up period of 24.6 months.

According to the findings, talazoparib plus enzalutamide significantly decreased the risk of disease progression or mortality compared to placebo and enzalutamide by 37%. This was true whether “homologous recombination repair,” or DNA repair gene mutations, were present or not (HRR).

Dr. Andrew J. noted that TALAPRO-2, which joins the PROPEL research, is the second randomised phase 3 trial to show a benefit with combination [androgen receptor] plus PARP inhibition in delaying rPFS in the first line [metastatic castration-resistant prostate cancer] context.

According to Dr. Armstronf, “the delays in rPFS range from > 50% relative improvements in HRR+ patients to 30-40% improvements in HRR-undetected individuals.

The results of TALAPRO-2 “differ from what was seen in the MAGNITUDE study with niraparib and abiraterone. Those without HRR deficiency (biomarker negative) group were stopped early due to lack of efficacy,” added Dr. Cora N. Sternberg, a genitourinary cancer specialist at Weill Cornell Medicine who was not involved in the study.

Data on overall survival were “immature” when the trial findings were announced. This indicates that more research is required to evaluate whether combination therapy with talazoparib and enzalutamide extends patient survival when compared to placebo and enzalutamide.

Is the combination therapy safe?

The study assessed any negative effects that men may have had from combination therapy.

The most frequent negative consequences were:

  • (65.8%) Anemia
  • reduction in neutrophil count (35.7%)
  • exhaustion (33.7%)
  • reduction in platelet count (24.6%)
  • Leukocyte count dropped (22.1%).
  • a backache (22.1%)
  • loss of appetite (21.6%
  • sickness (20.6%).

According to Dr. Zorko, the severe anaemia and neutropenia in the combination therapy group are not surprising given what is known about the side effects of PARP inhibitors.

Also, he advised that “before beginning combination therapy, consideration should be given to the necessity for transfusions and dose cessation. Particularly since 49% of patients had anaemia previous to therapy.”

The time toxicity required to obtain transfusions and supportive care in the clinic may further lessen patients’ enthusiasm for this oral combo therapy, the doctor added.

According to Dr. Armstrong, “there is higher toxicity and cost to patients getting combination [treatment], but these are tolerable for most patients and do not seem to impede quality of life in the long run in most patients with [dose] changes and side effect control.”

Study limitations and next steps

The primary limitations of this trial, according to Dr. Scott T. Tagawa, professor of medicine and urology at Weill Cornell Medicine who was not involved in it, include “early data for overall survival as well as [unknown] long-term adverse events.”

Dr. Zorko added: “In the trial, only 5.2% of patients had received abiraterone treatment in the past. We will see more patients in this area as they become castration-resistant as [triple therapy with] androgen-deprivation therapy, docetaxel, abiraterone/prednisone is used more frequently in the metastatic hormone-sensitive prostate cancer setting, but whether this specific subgroup benefits will be interesting to see.

The final stage of medication development was the phase 3 clinical trial. The FDA must now analyse the results of the clinical trials and make a determination regarding the applicability of this therapy to patients with metastatic castration-resistant prostate cancer. In 2023, the FDA is anticipated to make a decision regarding the clinical application.

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How can prostate cancer affects Sexual health?

How can prostate cancer affects Sexual health?

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Prostate cancer patients who are undergoing or have had treatment can experience sex-related issues. These include troubles with fertility, losing interest in sex, and getting an erection.

A lump or tumour is created when cells in the prostate tissue develop uncontrolled, a condition known as prostate cancer or cancer of the prostate gland. The urethra, the tube that takes urine from the bladder to leave the body, can become blocked if the tumour becomes large enough.

Prostate cancer often has little effect on sexual function, although in rare instances, it may cause erection problems. On the other hand, the entire cancer experience, including its effects on the reproductive system and its treatments, which may involve radiation therapy, surgery, or hormone therapy, might lead to issues.

The most prevalent non-skin cancer in men in the US is prostate cancer. According to the Centers for Disease Control and Prevention, about 13 out of every 100 American men are affected (CDC).

Psychological factors

It is common to experience anxiety and depression after receiving a cancer diagnosis and while undergoing treatment. Relationship tension can also be caused by anxiety.

Multiple physical changes brought on by prostate cancer might have an impact on a person’s sexual confidence. These may consist of:

  • Constipation issues and urine leaking
  • having trouble getting an erection
  • decreased generation of sperm
  • lower fertility
  • These problems may have an impact on sexual performance and desire.

An active course of treatment may not be necessary if the cancer is in its early stages and slow-growing. This strategy is referred to as cautious waiting. Although worry may persist and the individual may still have less interest in sex as a result, monitoring does not have adverse effects that lead to sex issues. Counseling could assist them in overcoming this.

Some people may be concerned that they have a sexually transmitted infection (STI), but prostate cancer is not a STI and cannot be transferred by sexual activity or any other method.

Prostate cancer affecting sex life

Even prior to starting treatment, having prostate cancer might have an impact on your sexual life. However, it could take some time for you to notice how it affects you.

Typically, prostate cancer doesn’t immediately affect how you sex (unless your prostate gets very large). However, receiving a cancer diagnosis, regardless of the type, can have psychological or emotional effects. And you’re less likely to be interested in having sex if your diagnosis makes you feel scared, apprehensive, or depressed. The term “poor libido” is sometimes used to describe this.

If you often engage in sexual activity with someone, they may experience stress or sadness as a result of your diagnosis, which could affect their libido as well.

And as you might expect, sex is less likely to occur frequently if neither you nor your spouse are particularly interested in having it. This suggests that those who receive a prostate cancer diagnosis may be less likely to engage in sexual activity. Additionally, initiating treatment for prostate cancer frequently results in new sexual difficulties.

Prostate cancer treatments affect your sex life?

Hormone therapy, surgery, and radiation therapy are the top prostate cancer treatments. Your sexual life may be impacted by any of these treatments. Because of this, it’s critical to comprehend the possibility of sexual side effects during prostate cancer therapy so that you and your healthcare team can make the best decisions possible.

Treatment for prostate cancer may have an impact on:

  • Libido (sex drive)
  • Erections
  • Ejaculation
  • sexual enjoyment
  • Testicle and penis size

Possible sexual side effects of prostate cancer and/or its treatment

Sexual adverse effects are conceivable with prostate cancer as well as the available therapies (surgery, radiation, and/or hormone therapy). The following list includes some of the most frequently mentioned side effects of prostate cancer on a person’s sexual function:

  • Erectile dysfunction: A man may occasionally struggle to achieve or sustain an erection following a prostatectomy (surgical to remove the prostate).
  • Loss of interest in sex: Managing a cancer diagnosis and receiving treatment can be stressful and draining, thus it is common for someone to momentarily lose interest in sex during this time. The desire for sexual activity can also be decreased by some medications, such as hormone therapy.
  • Ejaculatory issues: Men who have undergone therapy for prostate cancer may notice that their ejaculations are diminished or nonexistent. Compared to prior treatment, orgasm may also feel different.
  • Lack of self-assurance or low sexual self-esteem: Having trouble getting an erection, having urine leakage, and/or having less or no semen volume may all lead to feelings of sexual self-consciousness or performance anxiety.

Things a person can do for a healthy sex life after prostate cancer

One can overcome these challenges and regain a healthy sex life after cancer by being informed about the potential sexual health effects of prostate cancer and its treatment. Following prostate cancer therapy, a person can improve their sexual life in the following ways:

  • Penile rehabilitation: Improvements in erections within the first year following surgery may enhance general contentment and quality of life, while the effects of penile rehabilitation are still under question.
  • Erection aids: There are a number of erectile dysfunction treatments available, including prescription drugs, vacuum devices, and penile implants, which are mechanical devices inserted surgically into the penis to enable a man to get an erection whenever he wants.
  • Counseling or sex therapy: When it comes to sexual function, a person’s mental health is just as vital as their physical health. A person might think about consulting a psychologist or sex therapist for help through a significant life event, including receiving a cancer diagnosis and undergoing treatment.
  • Open communication: Honest, open communication with a sexual partner is essential for a patient who is in a relationship. This can reduce sexual performance anxiety for both partners, enable them to manage their expectations for their sexual connection, and build a foundation of trust for future intimacy.

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What’s the link between Cancer treatment and ED?

What’s the link between Cancer treatment and ED?

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Your sex life may change as a result of physical and psychological side effects of cancer treatment. These alterations are referred to as “sexual side effects” by doctors. They consist of modifications to your sex interest and your capacity for sexual action.

Physical, mental, or emotional adverse effects from sexual activity are possible. Your attitude, sense of wellbeing, energy level, and body image can all be impacted by cancer therapy. All of these factors can influence your sexual life.

Whether your cancer diagnosis and/or treatment may alter your sexual life is something you should discuss with your medical team. If at all possible, do this before beginning treatment. The optimal form of treatment for you can be impacted by it. Getting a second opinion might be wise if you are extremely concerned.

Sexual problem during cancer

Your sexual health may change as a result of having cancer or the therapy for it, either during or after treatment. These modifications could go or stay put. Everyone is unique.

Treatments that directly affect your genital organs are more likely to have physical side effects. Prostate, bladder, and testicular cancer treatments, for instance, are more likely than some other cancer treatments to have an impact on your capacity to physically engage in sexual activity. However, leukaemia treatment, for example, might also make you feel exhausted or ill, which can reduce your interest in sex. This is why discussing your unique diagnosis and what to expect with your medical team can be beneficial.

The following are examples of possible sexual side effects:

  • less sex-related interest
  • having trouble attaining or maintaining an erection long enough to engage in penetration. Other terms for this issue include “erectile dysfunction” and “ED.”
  • Orgasming before you’re ready is known as premature ejaculation.
  • urinating (peeing) while having an orgasm.
  • having a “dry” orgasm in which no sperm emerges. This can occur if semen exits the penis instead of flowing backward into the bladder.
  • suffering when having sex.

Inform your medical staff if you experience any of these issues before starting therapy. They might be able to assist or stop the difficulties from growing worse if they are aware of the issue. Additionally, during or after treatment, let your medical team know if you have any new issues or changes in your sexual health.

Treatments that can cause sexual problems

Surgery – The nerves that regulate erections can be harmed during procedures on the prostate, testicles, bladder, colon, and/or rectum. Consult your surgeon on “nerve-sparing” procedures. Additionally, surgery can result in “dry” ejaculation. You might find this upsetting or you might not.

Radiation treatment – ED may result after radiation therapy administered to the pelvis, which is the region around the hips. This may occur between six months and two years following the treatment. In two to three years, it might disappear or become better. What to do when you have ED should be discussed with your doctor.

Chemotherapy – Chemotherapy side effects can have an impact on your mood, sense of self, and sexual attraction. Weight gain or loss, nausea, vomiting, and diarrhoea are possible side effects. Additionally, you can stop having erections, but this normally returns with time. Any medication, including targeted therapy or immunotherapy, that is a part of your treatment plan should be discussed with your doctor for any potential sexual side effects.

Hormone treatment – Some prostate cancer treatments aim to reduce the amount of testosterone your body produces. Although it is done to treat the cancer, this may result in ED, reduced sex drive, and difficulties achieving an orgasm.

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