Bicalutamide: I know some of you use... - Fight Prostate Ca...

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Bicalutamide

dhccpa profile image
15 Replies

I know some of you use bicalutamide instead of one of the ARPIs.

Does bicalutamide work in the same manner as Xtandi, just much weaker?

Does bicalutamide pair well with ADT like Lupron or Orgovyx? Is there a complimentary effect?

Does bicalutamide have common adverse side effects with other drugs, supplements, etc?

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dhccpa
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Justfor_ profile image
Justfor_

It mainly boils down to the fact that Xtandi carries a price tag 100 times that of generic Bicalutamide. Follow the money and your queries will be answered.

FlyJ profile image
FlyJ

ascopubs.org/doi/10.1200/JC...

The Strive Study compares enzalutamide to bicalutamide. This study was done with castration resistant patients. It was using 50mg of bicalutamide. I would like to see a study done in hormone sensitive patients comparing bicalutamide to $ newer ARIs

Seasid profile image
Seasid in reply toFlyJ

Q. In the enzamet clinical trial Enzalutamide plus ADT was used from the start of the disease for one group of people.

In the control group bicalutamide and ADT was used.

Do you know the overall survival for this study?

A. In the ENZAMET trial, the addition of enzalutamide to androgen deprivation therapy (ADT) significantly improved overall survival in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to standard therapy with bicalutamide (or other nonsteroidal anti-androgens) and ADT.

At a median follow-up of 68 months, the median overall survival for the enzalutamide group had not yet been reached, indicating that more than half of the patients were still alive, whereas the median overall survival for the control group was around 73.2 months. This difference translates to a 30% reduction in the risk of death for those receiving enzalutamide, with a hazard ratio of 0.70. Additionally, the 5-year survival rate was higher in the enzalutamide group (67%) compared to the control group (57%).

This study highlights enzalutamide’s role in extending life expectancy when used early in hormone-sensitive metastatic prostate cancer, supporting its benefit as part of first-line therapy.

ChatGPT said

Seasid profile image
Seasid in reply toSeasid

chatgpt.com/share/67d46356-...

FlyJ profile image
FlyJ in reply toSeasid

Thanks for linking your Chatgpt log. That was very informative.

dhccpa profile image
dhccpa in reply toSeasid

How could the median survival be 73.2 months at 68 months?

Seasid profile image
Seasid

Q. Are you saying that when also early docetaxel is used for a treatment of high volume metastatic disease than the benefits of Enzalutamide plus ADT where not as substantial in comparison to the cohort of patients with docetaxel plus Bicalutamide plus ADT?

A. Yes, that’s correct. In the ENZAMET trial, enzalutamide plus ADT provided a significant survival advantage over bicalutamide plus ADT for patients with metastatic hormone-sensitive prostate cancer (mHSPC). However, when early docetaxel was also added to the treatment regimen, the additional benefit of enzalutamide over bicalutamide was less pronounced, especially in patients with high-volume disease.

For patients who received early docetaxel, enzalutamide plus ADT did not dramatically improve overall survival compared to docetaxel plus bicalutamide and ADT. This suggests that, in high-volume mHSPC, adding docetaxel early in treatment may provide sufficient androgen receptor inhibition, making the incremental benefit of enzalutamide smaller. Consequently, while enzalutamide still showed benefits in terms of progression-free survival and disease control, the impact on overall survival was less significant when combined with docetaxel in high-volume cases.

This finding highlights the importance of tailoring treatment strategies based on patient-specific factors, such as disease volume and tolerance for combination therapies like docetaxel.

ChatGPT said

Seasid profile image
Seasid in reply toSeasid

Q. What was the inclusion criteria for the study?

A. The ENZAMET trial included men with metastatic hormone-sensitive prostate cancer who met specific criteria. Key inclusion criteria were as follows:

1. Diagnosis and Stage: Participants had a confirmed diagnosis of metastatic adenocarcinoma of the prostate.

2. Performance Status: Men with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 were eligible, though those with a score of 2 were only included if the decline was due to prostate cancer.

3. Treatment History: Testosterone suppression therapy must have been started no more than 12 weeks before randomization. Prior testosterone suppression (up to 24 months) was allowed if completed more than 12 months prior.

4. Physical Health and Function: Participants had to meet minimum liver, renal, and bone marrow function requirements and be capable of completing trial requirements and assessments.

5. Consent and Compliance: Written informed consent was required, and participants had to be willing and able to follow all study protocols, including treatment and scheduled assessments.

Exclusion criteria included having a life expectancy of less than 12 months, previous seizures or significant cardiovascular issues, and prostate cancer with specific cellular characteristics such as neuroendocrine small-cell or sarcomatoid features.

ChatGPT said

Seasid profile image
Seasid in reply toSeasid

Q. If I good understand the set-up of the trial almost all of the participants had a de novo metastatic diagnosis because the inclusion criteria asked for that the testosterone suppression didn't start more than 12 weeks before the randomisation.

A. Yes, you’re correct in noting that the ENZAMET trial primarily included participants with a de novo (newly diagnosed) metastatic prostate cancer, which means the cancer had spread to other parts of the body by the time of initial diagnosis. This is implied by the inclusion criteria, specifically the requirement that androgen deprivation therapy (ADT) must have begun no more than 12 weeks before randomization. This short timeframe means the trial focused on men who had not been undergoing long-term treatment for prostate cancer but were instead starting treatment soon after a metastatic diagnosis.

Some patients with previous ADT for localized prostate cancer could be included if it had ended more than a year prior, which allowed for a few cases where metastasis occurred after initial treatment. However, most of the participants were likely to have had a recent de novo metastatic diagnosis due to the 12-week ADT initiation limit.

ChatGPT said

Seasid profile image
Seasid in reply toSeasid

Q. Is it true that Enzalutamide was only superior when the number of metastasis were few?

A. In the ENZAMET trial, Enzalutamide showed a survival advantage over traditional non-steroidal antiandrogens like bicalutamide, even across different subgroups of metastatic hormone-sensitive prostate cancer (mHSPC) patients, such as those with both high and low metastatic volumes. However, the degree of benefit varied: Enzalutamide provided notable survival benefits especially in patients with lower-volume disease compared to those with high-volume disease. High-volume patients also benefited but to a slightly lesser extent.

Additionally, the trial noted that combining Enzalutamide with docetaxel chemotherapy did not yield significant survival improvements compared to Enzalutamide alone, although progression-free outcomes were generally enhanced. These findings underscore that while Enzalutamide is broadly effective, its most substantial impact was observed in patients with fewer metastases or lower tumor burdens, possibly due to better disease control in these groups over the long term.

For more details, you can refer to updates and data from ENZAMET's ASCO presentations and other reports on the trial findings.

ChatGPT said

Seasid profile image
Seasid in reply toSeasid

Q. Could you please compare the overall survival on Enzalutamide in comparison to bicalutamide (or similar drugs) for the cohort of patients with high volume disease?

A. In the ENZAMET trial, enzalutamide combined with androgen deprivation therapy (ADT) showed an overall survival (OS) benefit compared to standard non-steroidal anti-androgen therapy, which included drugs like bicalutamide, for patients with metastatic hormone-sensitive prostate cancer (mHSPC). For patients with high-volume disease, the results were nuanced: enzalutamide improved overall outcomes, but the survival benefit was somewhat reduced in this subgroup when compared to patients with low-volume disease. Specifically, the survival improvement for high-volume patients was evident, but not as substantial as in the low-volume cohort.

While the trial did not provide separate, median OS values solely for high-volume patients treated with enzalutamide vs. bicalutamide, it showed that enzalutamide significantly prolonged survival across all subgroups. Enzalutamide with ADT continued to outperform the control treatment with an approximately 10% increase in five-year OS rates for the total trial population, though this effect varied slightly by disease volume and concurrent docetaxel use.

Thus, while enzalutamide generally outperformed bicalutamide in terms of survival for high-volume disease patients, the relative benefit was more modest compared to low-volume disease groups due to differences in disease progression and metastasis patterns in high-volume cases. These findings highlight enzalutamide's advantage as a treatment option, albeit with variable effects across patient subgroups based on disease volume and treatment combinations.

For more detail, you may refer to sources from UroToday and ASCO.

ChatGPT said

Seasid profile image
Seasid in reply toSeasid

Q. Could you give me some statistics and numbers for a high volume patient group?

A. In the ENZAMET trial, the outcomes for patients with high-volume metastatic hormone-sensitive prostate cancer (mHSPC) receiving enzalutamide varied based on additional treatments like early docetaxel.

For high-volume patients, those on enzalutamide combined with androgen deprivation therapy (ADT) had improved survival rates over the control group on ADT with standard anti-androgens such as bicalutamide. In the subgroup with high-volume disease, about 71% of enzalutamide patients were still alive at 3 years, compared to 64% in the control group. When early docetaxel was not included, enzalutamide reduced mortality more significantly (with a hazard ratio around 0.67 overall) and extended survival relative to other non-steroidal antiandrogens (such as bicalutamide), which was particularly clear in high-volume cases.

These findings support enzalutamide as an effective addition to ADT for high-volume mHSPC, especially when docetaxel is not feasible or is reserved for later treatment stages. However, for patients fit for chemotherapy, combinations including docetaxel may provide complementary benefits in survival and disease control.

ChatGPT said

Seasid profile image
Seasid

Q. Could you please explain me in detail so I can understand the meaning of this statement?:

"Pluvicto was also associated with better overall survival: 15.3 months versus 11.3 months."

A. This statement compares the overall survival time of two groups of patients, with one group receiving the treatment called Pluvicto and the other group not receiving it. Here’s a breakdown of what it means:

Overall Survival: This refers to the average time that patients remain alive after starting a particular treatment. It’s a measure of the treatment's effectiveness in prolonging life.

15.3 months versus 11.3 months: Patients who received Pluvicto lived an average of 15.3 months, while those who did not receive it lived an average of 11.3 months. This suggests that Pluvicto may extend patients' lives by an average of 4 months compared to the alternative treatment or control group.

So, the statement implies that Pluvicto was associated with a longer overall survival, showing a potential benefit for patients taking it. This survival benefit is usually considered important when assessing a new treatment's effectiveness.

ChatGPT said

Seasid profile image
Seasid in reply toSeasid

Q. What does exactly mean overall survival?

A. Overall survival (OS) is a term used in clinical studies to measure the length of time from either the start of treatment or diagnosis until death from any cause. It’s a way of gauging how effective a treatment is in extending a patient’s life.

For example, if a study says a treatment leads to an overall survival of 15 months, this means that, on average, patients lived 15 months after starting the treatment. It doesn’t mean every patient lived exactly 15 months—some may have lived longer, others shorter. OS is a commonly used endpoint in studies because it’s a clear, definitive measure of a treatment’s potential to improve life expectancy.

ChatGPT said

Seasid profile image
Seasid in reply toSeasid

Q. What does it mean survival rate and when this expression is used (if at all?)?

A. The survival rate is a term used in healthcare and medical research to indicate the percentage of people who are still alive after a specific period following a diagnosis or treatment. Survival rates help researchers and doctors understand the effectiveness of treatments and give patients an idea of their prognosis.

Here’s a breakdown:

1. Types of Survival Rates:

1-year, 5-year, or 10-year survival rate: These indicate the percentage of people alive one, five, or ten years after diagnosis or treatment. For instance, a “5-year survival rate” of 70% means that 70% of people are still alive five years after diagnosis.

Disease-free survival rate: This is the percentage of people who survive without signs of the disease returning.

Progression-free survival rate: This measures the percentage of people whose disease has not worsened over a specified period.

2. When It’s Used:

Survival rates are commonly used in cancer studies and other long-term illness research to understand how likely it is for patients to survive a set period after diagnosis.

It’s also used in public health to monitor improvements in treatment over time.

Survival rates are different from overall survival, which is an average time, while survival rate gives a percentage of patients surviving after a certain time. Both are important metrics in assessing treatment outcomes.

ChatGPT said

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