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Impact of Phase III Trials on Hormone Therapy for Prostate Cancer

Recent Phase III trials, such as ARAMIS and ARASENS, have significantly influenced treatment protocols for prostate cancer. These trials provide critical insights into the efficacy of hormone therapies in managing both non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC). 

ARAMIS Trial Key finding: Patients with nmCRPC who received early treatment with an androgen receptor inhibitor (AR inhibitor) experienced a significant improvement in progression-free survival compared to those who received delayed treatment.

ARASENS Trial Key finding: Patients with mHSPC who received a combination of hormone therapy and docetaxel demonstrated improved overall survival and progression-free survival compared to those who received hormone therapy alone.

The outcomes from these studies are shifting clinical practices, leading to more tailored and effective treatment regimens. As these trials guide therapeutic decisions, it is crucial to consider how these findings align with current clinical guidelines and patient-specific factors.

How have the findings from these trials influenced your prescribing practices for hormone therapies? What changes have you made or are you considering in your treatment approach based on this evidence?

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    Nubeqa has been proven effective in the key end point of progression free survival advantage in the metastatic, castrate sensitive, and the non-metastatic castrate resistant settings.
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    I have adopted both trials in clinical practice and am pleased with the tolerable side effects of ARI with or without chemotherapy. It has definitely improved outcomes and QOL in prostate cancer patients
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    I use the ARI with chemotherapy in mHSPC and also nmCRPC, the chemotherapy is time limited with 6 cycles makes it very tolerable.
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    With regard to ARASENS, the triplet combination was superior to the doublet.
    While chemo is likely underutilized in prostate cancer patients - there is a subset of patients age >85, those with neuropathy, or poor ECOG PS that I would be hesitant to use this in.
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    obviously these are important trials unfortunately they missing data for specific populations such as BRCA or HRD positive populations; furthermore different official label makes it difficult to secure reimbursement for patients or to use your favored ARI across different settings
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    ARI's continue to gain approval in additional setting. Triplet therapy in mHSPC is appropriate and well tolerated in pts who have good performance status. Adding nubeqa in nmHRPC has also become SOC for me.
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    With regard to ARASENS, chemo is likely underutilized in this patient population. We give taxotere all the time for women with breast cancer (TC) but feel it’s too toxic for men with prostate cancer (?)

    Androgen inhibitors are becoming standard of care now
  • 1yr
    I have adopted the findings of these trials in my practical care of patients with advanced prostate carcinoma. Since most of the nmCRPC patients are being cared for my Urologists, ARAMIS data is somewhat less relevant for me. However I do think addition of ARI makes a Hugh difference in metastasis free survival. For patients with mHSPC, I use the ARASENS data to guide my treatment. I use the combination of ARI + ADT + Chemotherapy. These are significant advancements and makes a meaningful improvement in lives of our patient
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    Generally agree with colleagues comments in that the triple therapy upfront seems to be the trend
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    This triple drug approach seems to be optional first line therapy for CSPC
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    Long gone are the days of waiting on a CRPC patient to "become" metastatic when we can finally see a lesion on imaging. Having to scan them over and over again. We have seen an exciting change in the paradigm and being able to offer men these new agents earlier in their disease progress. I feel it is prudent to encourage newly diagnosed men to move on to receive chemo upfront because they are younger, healthier and more likely to tolerate it totally fine. For the OS and PFS benefit of these anti-androgen agents, along with the generally good tolerability compared to many cancer treatments, we need to be offering this treatment to our patients. Sadly, national data shows there are many who still are left on ADT alone. We need to do better as a community.
  • 1yr
    These are exciting times. Luckily, we have seen a shift in earlier treatment with new anti-androgen medications. Long gone are the days of just waiting for the HRPC patient to become metastatic to be able to offer them additional therapy. Treating these men earlier (when they are younger and healthier) with upfront chemo is a good option for most. We don't have to just keep scanning and scanning them hoping to "find" a metastatic lesion. Proven benefit in OS, PFS. Good tolerability compared to many chemotherapeutic agents. Unfortunately, the national data shows many men are still not receiving these agents and being left on ADT alone. I encourage the community to give our patients the best chance we can.
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    Definitely the shift has been towards more aggressive triplet therapy upfront, although side effect toxicity still is a significant issue and so patient population is important who to choose. The comorbidities of each patient has to be considered carefully in balance with effectiveness of therapies.
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    I have been using novel hormonal agent in nmCRPC for years, so this does not change my approach. Likewise, I have been using the combination of hormonal therapy and docetaxel in HSPC for high tumor burden patients as well. The biggest barrier is tolerability
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    I use above data in practice already.
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    I have already incorporated these 2 options into my practice.
    For nmCRPC i use AR ( since introduction of Apalutamide) to reduce metastatic CRPC.
    ARASENS is what i would use in patients with visceral/ extensive metastatic disease, relatively young ( 45-70 year old) patients selectively - unclear if chemo is absolutely beneficial as my colleagues mentioned.
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    I have already incorporated these 2 options into my practice.
    For nmCRPC i use AR ( since introduction of Apalutamide) to reduce metastatic CRPC.
    ARASENS is what i would use in patients with visceral/ extensive metastatic disease, relatively young ( 45-70 year old) patients selectively - unclear if chemo is absolutely beneficial as my colleagues mentioned.
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    If the patient has extensive metastatic disease, I definitely like the triplet therapy so as to have durability of response with a higher PFS and OS. Wewill know the result of the ARANOTE trial which will be presented at ESMO next week whether Chemotherapy is absolutely needed in the combination. we will be able to compare ARANOTE with ARASENS study.
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    using AR inhibitor in nmCRPC has been my practice, glad to see clinical trial validation, but in pts who are minimally symptomatic or asymptomatic, it may not be extremely beneficial to offer such therapy.

    Triple therapy is only beneficial in pts with high tumor burden, which I recommend to pts
  • 1yr
    I offer the triplet combination in patients with higher tumor board, younger, good performance status and motivated. this offers in an overall survival advantage, which is the gold standard in oncology so it’s hard not to offer this regimen to the appropriate patient. For non-metastatic disease, it makes sense that our more active oral agents, androgen, receptor inhibitors, would lead to better outcomes so I offer it as well. Both of these trials have led to practice changes.
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    yes, gives us recommendations of either using some combination, either anti-androgen or chemotherapy. Discussion also is in which group to add chemo usually is high risk or tumor burden.
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    I use darolutamide as preferred NAT and feel it’s use could be optimized by allowing use without chemotherapy like apalutimide
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    It is very influential. I offer docetaxel combo therapy options to majority of my patients
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    The androgen inhibitors should be used early and often. Darolutamide typically preferred as it has the best side effect profile. The niches for FDA approval can be limiting however. It is nice to be able to give alone or with chemotherapy.
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    Agree with the colleagues here that my prescribing habits have changed especially based on ARASENS. I use the combination selectively in younger patients with high disease burden and visceral mets and 1st line in those patients. They usually have good performance status like ECOG 0 or 1. ARAMIS is interesting as well although I have not had an appropriate patient yet to implement this but would consider it in the appropriate situation
  • 1yr
    I offer combination therapy with triplets for high burden symptomatic patient with mhspc.
    I have been using hormonal therapy for quite sometime nmcrpc but has run into issues with insurance coverage for psa doubling time >10 months
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    yes for high risk pts use triplets or doublets based on trial data
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    I agree and have been using more chemo with Androgen inhibitor therapy especially for higher risk patients (high Gleason score, etc).
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    I am referring more patients to Oncology with nigh risk mcspc for Nubeqa,Taxotere and ADT therapy based on Arasens trial data.
    I am also using combination ADT and Xtandi as SOC for mspc and nmcrpc.
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    Arasens I use in my pts with mainly high volume ds and visceral Mets mainly add taxotere to ADT also using Androgen receptor inhibitor in Non metastatic CRPC pt s to improve PFS
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    Androgen receptor inhibitors have improved progression-free survival, overall survival, and delayed skeletal-related events compared to those who received delayed treatment -and is currently the standard of care, regarding ARASENS clinical trial - I am currently using it a subset of patients benefit from the combination of the hormone therapy and docetaxel -patients with good performance status with limited comorbidities, and young patient's and patient's with higher disease burden.
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    There is no question about using the androgen receptor inhibitors early on provide significant benefit in PFS and or OS; however, there is a concerned about use of chemotherapy in combination in the first line setting due to its associated toxicity. There are appropriate scenarios and specific patients subset who may benefit from this combination (AI+ chemo) though.

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