Tag: Prostate Cancer

SUMMARY: Prostate cancer is the most common cancer in American men with the exclusion of skin cancer, and 1 in 9 men will be diagnosed with prostate cancer during their lifetime. It is estimated that in the United States, about 164,690 new cases of Prostate cancer will be diagnosed in 2018 and 29,430 men will die of the disease. Approximately 35% of the patients with Prostate cancer will experience PSA only relapse within 10 years of their primary treatment with Radical Prostatectomy or Radiation Therapy and a third of these patients will develop documented metastatic disease within 8 years following PSA only relapse. Several studies have addressed how diet and environmental factors affect the risk of Prostate cancer.

According to the American Cancer Society, tobacco use is responsible for nearly 1 in 5 deaths in the United States and accounts for at least 30% of all cancer deaths. Tobacco smoke contains more than 70 well known carcinogens and smoking is known as a preventable risk factor for several genitourinary malignancies cancers such as upper tract urothelial carcinoma, Bladder cancer and Renal Cell Carcinoma. The effect of smoking on the incidence of Prostate cancer has however remained unclear. Nicotine in tobacco smoke has been implicated as a disease driver and there is a significant correlation between smoking and multigene hypermethylation. Further, more unfavorable pathologic features have been noted during Radical Prostatectomy among smokers. Additionally, there is an independent association of cigarette smoking with time to castration resistance, in patients with advanced Prostate cancer undergoing Androgen Deprivation Therapy.

The purpose of this study was to systematically review and analyze the association of smoking status with biochemical recurrence, metastasis, and cancer-specific mortality among patients with localized Prostate cancer undergoing primary curative treatment with radical prostatectomy or radiotherapy. The authors performed a systematic search of original articles published between January 2000 and March 2017 using PubMed, MEDLINE, Embase, and Cochrane Library databases and they identified a total of 5157 studies of which 16 articles were selected for qualitative analysis and 11 articles were selected for quantitative analysis. All included studies were observational and nonrandomized. The meta-analysis overall included 22 549 patients, of whom 4202 (18.6%) were current smokers at the time of primary curative treatment, and 18,347 (81.4%) were nonsmokers (former and never smokers combined). The overall median follow-up was 72 months. The prespecified outcomes evaluated were, biochemical recurrence, metastasis, and cancer-specific mortality.

It was noted that current smokers had a significantly higher risk of experiencing BCR (BioChemical Recurrence) compared with nonsmokers whether they had undergone RP or RT (HR=1.40; P< 0.001). The same findings were noted among former smokers (HR=1.19; P<0.001). Current smokers were also at a higher risk of metastasis (HR=2.51; P<0 .001) and cancer-specific mortality (HR=1.89; P<0.001), but this was not observed among former smokers, for metastasis (HR=1.61; P=0.31) and cancer-specific mortality (HR=1.05; P=0.70).

It was concluded that current smokers at the time of primary curative treatment for localized Prostate cancer are at higher risk of experiencing Biochemical Recurrence, metastasis, and cancer-specific mortality, suggesting that smoking is a modifiable risk factor that affects all disease phases of Prostate cancer. Health Care Providers caring for Prostate cancer patients should be encouraged to counsel patients on smoking cessation, given the risk of poorer outcomes associated with smoking. The authors also noted that this is the first systematic review and meta-analysis that investigated the association of smoking with oncologic outcomes, after primary treatment for localized Prostate cancer. Association of Smoking Status With Recurrence, Metastasis, and Mortality Among Patients With Localized Prostate Cancer Undergoing Prostatectomy or Radiotherapy A Systematic Review and Meta-analysis. Foerster B, Pozo C, Abufaraj M, et al. JAMA Oncol. 2018;4:953-961.

SUMMARY: Prostate cancer is the most common cancer in American men with the exclusion of skin cancer, and 1 in 9 men will be diagnosed with prostate cancer during their lifetime. It is estimated that in the United States, about 164,690 new cases of prostate cancer will be diagnosed in 2018 and 29,430 men will die of the disease. Prostate cancer is driven by Androgen Receptor (AR) and its signaling pathways. Initial treatment strategies for patients with metastatic prostate cancer include lowering the levels of circulating androgens with medical or surgical castration or blocking the binding of androgens to the androgen receptor. Upon progression, {described as Castrate Resistant Prostate Cancer (CRPC), as these tumors are not androgen independent and continue to rely on Androgen Receptor signaling}, Androgen Receptor Signaling (ARS) inhibitors, such as ZYTIGA ® (Abiraterone acetate) and XTANDI® (Enzalutamide), and Taxanes such as TAXOTERE® (Docetaxel) and JEVTANA® (Cabazitaxel) are the most widely used drug classes in the United States. ZYTIGA® inhibits CYP17A1 enzyme and depletes adrenal and intratumoral androgens, thereby impairing AR signaling. XTANDI® competes with Testosterone and Dihydrotestosterone and avidly binds to the Androgen Receptor, thereby inhibiting AR signaling, and in addition inhibits translocation of the AR into the nucleus and thus inhibits the transcriptional activities of the AR. About 20-40% of the patients do not respond to these newer agents (ARS inhibitors), and even those who respond will invariably develop resistance to these drugs.

ARS inhibitors are often the preferred choice for the first-line treatment of metastatic CRPC (mCRPC). In clinical practice, the majority of patients with mCRPC who progress on first-line ARS inhibitor receive a second ARS inhibitor, as there are no formal guidelines on how best to sequence these agents after progression on first-line ARS inhibition. Resistance to ARS inhibitors has been attributed to persistent AR signaling by variant forms of Androgen Receptor, generated through somatic mutation or aberrant RNA splicing. Androgen Receptor splice Variant 7 (AR-V7) is the most widely studied and can be detected in the CTCs (Circulating Tumor Cells). AR-V7 does not have the domain to bind androgens and may be associated with resistance to XTANDI®. Further AR-V7 is constitutively active and can independently activate transcription factors and therefore is not effected by androgen depleting agents including ZYTIGA®.

A critical unmet need is a test that can provide guidance on selecting appropriate therapy in the second and later lines, for this patient group. Accurately detecting a splice variant of the Androgen Receptor protein (AR-V7) in the nucleus of Circulating Tumor Cells (CTCs) using peripheral blood (liquid biopsy), would enable treating physicians to confidently decide whether patients treated with an ARS inhibitor, upon progression, would benefit from a second ARS inhibitor or should be switched to chemotherapy. This study focused on the patients receiving second-line treatment, to determine if an assay for the nuclear-localized AR-V7 protein in CTCs can be used to determine treatment for mCRPC.

The authors conducted this independent, multicenter cohort study to determine whether a validated assay for the nuclear-localized Androgen Receptor splice Variant 7 (AR-V7) protein in Circulating Tumor Cells (CTCs) can be used as a treatment-selection marker for metastatic CRPC, and whether it can determine Overall Survival difference among patients with mCRPC treated with Taxanes versus ARS inhibitors. This blinded correlative study included 142 patients with histologically confirmed mCRPC. Blood samples were obtained prior to administration of ARS inhibitors (N=70) or Taxanes (N=72), as a second-line therapy or later, for progressing mCRPC . Mean age was 69.5 years. Seventy (N=70) patients were designated as high risk by conventional prognostic factors. The Primary outcome measure was Overall Survival after treatment with an ARS inhibitor or Taxane, in relation to pretreatment AR-V7 status.

It was noted that the presence of AR-V7 protein in CTCs was associated with a greater benefit from Taxane treatment whereas outcomes in AR-V7 negative patients were better with ARS inhibitor treatment. The median survival of patients with AR-V7 negative CTCs was 19.8 months for those treated with an ARS inhibitor and 12.8 months for those treated with a Taxane (P=0.05). In contrast, among patients with AR-V7 positive CTCs, those receiving Taxanes had longer observed median survival times compared to those treated with ARS inhibitors (14.3 vs 7.3 months; HR=0.62; P=0.25). The observed difference was not statistically significant and may have been attributable to the small sample size.

The authors concluded that this study suggests that nuclear-localized AR-V7 protein in Circulating Tumor Cells (liquid biopsy test) can identify patients who may live longer with Taxane chemotherapy versus ARS inhibitor treatment. This tailored treatment approach addresses a critical unmet need by predicting and enabling selection of therapy that can improve median survival. Assessment of the Validity of Nuclear-Localized Androgen Receptor Splice Variant 7 in Circulating Tumor Cells as a Predictive Biomarker for Castration-Resistant Prostate Cancer. Scher HI, Graf RP, Schreiber NA, et al. JAMA Oncol. Published online June 28, 2018. doi:10.1001/jamaoncol.2018.1621

SUMMARY: Prostate cancer is the most common cancer in American men with the exclusion of skin cancer, and 1 in 9 men will be diagnosed with prostate cancer during their lifetime. It is estimated that in the United States, about 164,690 new cases of prostate cancer will be diagnosed in 2018 and 29,430 men will die of the disease. Prostate cancer patients with newly diagnosed radiographic evidence of metastatic disease, either as part of a de novo diagnosis of prostate cancer, or as a manifestation of disease progression from an earlier clinical disease state, are considered to have “clinical metastatic: non-castrate” disease, by Prostate Cancer Working Group, provided that they have testosterone levels in the non-castrate level (more than 50 ng/dL). These patients may or may not have received limited courses of Androgen Deprivation Therapy (ADT) for their earlier clinical states.

The standard therapy for newly diagnosed metastatic non-castrate prostate cancer has been ADT alone. Upon progression, these patients are described as having metastatic Castration Resistant Prostate Cancer (mCRPC). These patients are continued on ADT and are offered additional treatments.

The ASCO multidisciplinary Expert Panel developed this guideline, following a systematic review of all phase III randomized controlled trials and meta-analyses, published from 2015 through October 2017. These studies included men with metastatic non-castrate prostate cancer (testosterone levels more than 50 ng/dL), being considered for treatment with Docetaxel (TAXOTERE®) or Abiraterone (ZYTIGA®), in addition to ADT. The Clinical Practice Guidelines are provided by the American Society of Clinical Oncology, (ASCO) to assist providers in clinical decision making.

This clinical practice guideline addresses the addition of Abiraterone or Docetaxel to Androgen-Deprivation Therapy (ADT) for metastatic prostate cancer, that has not been treated (or has been minimally treated) with testosterone-lowering agents.

Guideline Question: Is there an Overall Survival (OS) advantage associated with the addition of Docetaxel or Abiraterone to Androgen-Deprivation Therapy (ADT) in men with metastatic non-castrate prostate cancer? Other outcomes of interest include Progression-Free Survival (PFS), Failure-Free Survival (FFS), PSA response, Overall Response Rate, and Quality of Life (QOL).

Target Population: Men with metastatic non-castrate prostate cancer being considered for treatment with ADT.

Key Recommendations and Qualifying Statements:

ADT Plus Docetaxel

1) Docetaxel in addition to to ADT should be offered for men with metastatic non-castrate prostate cancer with High-Volume Disease (HVD), who are candidates for treatment with chemotherapy, as the strongest evidence of benefit for Docetaxel is for those men who were diagnosed with de novo metastatic disease or HVD, per CHAARTED study.

2) CHAARTED trial is a randomized phase III trial in which patients with newly diagnosed metastatic prostate cancer, were randomly assigned to receive either Androgen Deprivation Therapy alone or ADT plus Docetaxel. The addition of Docetaxel to ADT significantly prolonged Overall Survival in men with High-Volume Disease.

3) In the CHAARTED study, High-Volume Disease was defined as four or more bone metastases, one or more of which is outside of the spine or pelvis, and/or the presence of any visceral disease. The criteria were agnostic to the presence or absence of nodal disease.

4) For patients with Low-Volume Disease (LVD) and who are candidates for chemotherapy, Docetaxel plus ADT may be offered per CHAARTED study. However, the strength of the evidence to support an OS benefit is less compelling for men who do not have de novo metastatic disease and/or who do not meet the HVD criteria. A subset analysis of CHAARTED did not demonstrate a survival benefit for Low-Volume Disease, and the GETUG-15 trial was negative.

5) The appropriate regimen of Docetaxel is 75 mg/m2 every 3 weeks for 6 cycles either alone or with prednisolone.

ADT Plus Abiraterone

1) For men with high-risk, de novo metastatic non-castrate prostate cancer, Abiraterone in addition to ADT should be offered per LATITUDE study.

2) LATITUDE is a randomized, double-blind, placebo-controlled, phase III trial, which evaluated the clinical benefit of adding Abiraterone along with Prednisone to Androgen Deprivation Therapy (ADT), as compared with ADT and placebo, in patients with newly diagnosed, metastatic non-castrate prostate cancer. The addition of Abiraterone to ADT significantly increased Overall Survival and radiographic Progression Free Survival, in this patient group.

3) LATITUDE trial defined high-risk factors associated with a poor prognosis and included at least two of the following three high-risk factors: a Gleason score 8 or greater, 3 or more bone lesions, and presence of measurable visceral disease.

4) For men with lower-risk de novo metastatic non-castrate prostate cancer, Abiraterone may be offered per STAMPEDE study. STAMPEDE trial did not include a high risk definition.

5) LATITUDE and STAMPEDE are mutually supportive for treating high-risk disease with ADT and Abiraterone, with only STAMPEDE furnishing evidence that includes men with lower-risk disease.

6) The appropriate regimen is Abiraterone 1000 mg with either prednisolone or prednisone 5 mg orally once daily, until treatment(s) for mCRPC are initiated.

Docetaxel and Abiraterone

Docetaxel and Abiraterone should be considered as two separate standard treatments for metastatic non-castrate prostate cancer. These two standards have not been compared head to head, and their benefits seem to be quite similar. It is not known which patient subgroups might do better with one standard as opposed to the other and therefore practical factors should be taken into consideration. The use of both standards in combination or in series has not been assessed and therefore cannot be recommended.

In summary, the addition of either Docetaxel or Abiraterone to ADT in men with newly diagnosed metastatic prostate cancer offers a survival benefit, as compared with the use of ADT alone. In the absence of randomized data comparing the addition of Docetaxel versus Abiraterone to ADT in men with metastatic non-castrate disease, additional variables including patient comorbidities, toxicity, QOL considerations, drug availability, and cost will ultimately need to be taken into consideration.

Optimizing Anticancer Therapy in Metastatic Non-Castrate Prostate Cancer: American Society of Clinical Oncology Clinical Practice Guideline. Morris MJ, Rumble RB, Basch E, et al. J Clin Oncol 2018;36:1521-1539.

TransRectal UltraSound (TRUS) guided biopsy has been the standard of care for diagnosing prostate cancer in men with a clinical suspicion of prostate cancer. TRUS guided biopsy is a blind biopsy of the lateral and posterior peripheral zone of the prostate using a template, and 10 to 12 cores of prostate tissue is obtained. Even though this may result in a higher rate of prostate cancer detection, many detected are low grade tumors that do not benefit from treatment. The major limitation of this biopsy procedure is the risk of under-sampling a more significant tumor that is located in a region of the prostate not usually targeted with a template.
Multiparametric MRI (mp-MRI) combines anatomic imaging in the form of T2-weighted imaging, with functional imaging, and is being used to detect or rule out cancer in men who have persistent concern for prostate cancer. It can be used as a triage test to avoid a biopsy if the results were negative, and if positive could be used for targeting abnormal areas in the prostate during biopsy. In the PRECISION study, mp-MRI was superior to standard TRUS guided biopsy, and was able to identify a high proportion of men who would benefit from treatment, and minimizes the identification of men with clinically insignificant cancer, thereby preventing overtreatment. Utilizing mp-MRI, more than 25% of the participants in this study were able to avoid a biopsy.

SUMMARY: Prostate cancer is the most common cancer in American men with the exclusion of skin cancer, and 1 in 9 men will be diagnosed with prostate cancer during their lifetime. It is estimated that in the United States, about 164,690 new cases of prostate cancer will be diagnosed in 2018 and 29,430 men will die of the disease. TransRectal UltraSound (TRUS) guided biopsy has been the standard of care for diagnosing prostate cancer in men with a clinical suspicion of prostate cancer, based on an abnormal Digital Rectal Examination and/or an elevated Prostate Specific Antigen (PSA) level. TransRectal UltraSound (TRUS) guided biopsy is a blind biopsy of the lateral and posterior peripheral zone of the prostate using a template, and 10 to 12 cores of prostate tissue is obtained. Even though this may result in a higher rate of prostate cancer detection, many detected are low grade tumors that do not benefit from treatment, and these patients are on active surveillance for their low risk disease. The major limitation of this biopsy procedure is the risk of under-sampling a more significant tumor that is located in a region of the prostate not usually targeted with a template. Further, in patients with a rising PSA with a prior negative biopsy, patients are often subjected to a repeat blind biopsy with the same limitations as the original biopsy. Since biopsy access is through the rectum and only specific zones of the prostate are sampled, large areas of the prostate, especially the anterior and central prostate, are not routinely sampled and clinically significant higher-grade cancers are sometimes missed.

Multiparametric MRI (mp-MRI) combines anatomic imaging in the form of T2-weighted imaging, with functional imaging and is being used to detect or rule out cancer in men who have persistent concern for prostate cancer. Previously published studies have shown that MRI-targeted biopsies alone have shown similar or higher rates of detection of clinically significant cancer in the prostate gland and lower rates of detection of clinically insignificant cancer, when compared to standard TRUS guided biopsy. This interesting advantage allows the use of mp-MRI as a triage test to avoid a biopsy if the results were negative, and if positive could be used for targeting abnormal areas in the prostate during biopsy.

The PRECISION (Prostate Evaluation for Clinically Important Disease: Sampling Using Image Guidance or Not?) trial is a multicenter, randomized, noninferiority study, which prospectively evaluated whether mp-MRI with targeted biopsy in the presence of an abnormal lesion, was noninferior to standard TRUS guided biopsy, in the detection of clinically significant prostate cancer in men, with a clinical suspicion of prostate cancer, who had not undergone biopsy previously. A total of 500 men were randomly assigned in a 1:1 of whom 252 participants were assigned to the MRI-targeted biopsy group (N=252) and 248 to the standard 10-12 core TRUS guided biopsy group (N=248). The baseline characteristics of the participants were similar in the two groups. Eligible participants were required to have a PSA level of 20ng/ml or less, no evidence of extracapsular disease on Digital Rectal Examination and be suitable candidates for an MRI and biopsy of the prostate. Clinically significant prostate cancer was defined as the presence of disease of Gleason sum 7 or higher. Men who had a positive mp-MRI test underwent MRI-targeted biopsy of only these qualifying lesions (up to three areas). The Primary outcome was the proportion of men who received a diagnosis of clinically significant cancer. Secondary outcomes included the proportion of men who received a diagnosis of clinically insignificant cancer.

It was noted that multiparametric MRI was superior to standard TRUS guided biopsy, with a significantly higher percentage of men receiving a diagnosis of clinically significant prostate cancer in the MRI-targeted biopsy group, as compared with the standard TRUS guided biopsy group (38% versus 26%, P=0.005). Further, fewer men in the MRI-targeted biopsy group than in the standard biopsy group received a diagnosis of clinically insignificant cancer (9% versus. 22%, P<0.001). In the MRI-targeted biopsy group, 28% of the men had mp-MRI results that were not suggestive of prostate cancer, and therefore did not undergo biopsy.

It was concluded that in men with a clinical suspicion of prostate cancer and had not undergone biopsy previously, the use of risk assessment with MRI before biopsy and MRI-targeted biopsy, was superior to standard TRUS guided biopsy. MRI-targeted biopsy is able to identify a high proportion of men who would benefit from treatment, and minimizes the identification of men with clinically insignificant cancer, thereby preventing overtreatment. Utilizing mp-MRI, more than 25% of the participants in this study were able to avoid a biopsy. MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis. Kasivisvanathan V, Rannikko AS, Borghi M, et al. N Engl J Med 2018; 378:1767-1777

SUMMARY: The FDA on February 7, 2018, approved ZYTIGA® (Abiraterone acetate) in combination with Prednisone for metastatic high-risk Castration Sensitive Prostate Cancer (CSPC). The FDA initially approved ZYTIGA® with prednisone in 2011 for patients with metastatic Castration Resistant Prostate Cancer (CRPC), who had received prior chemotherapy, and the FDA expanded the indication in 2012, for patients with chemo naïve metastatic CRPC. Prostate cancer is the most common cancer in American men with the exclusion of skin cancer and 1 in 9 men will be diagnosed with prostate cancer during their lifetime. It is estimated that in the United States, about 164,690 new cases of Prostate cancer will be diagnosed in 2018 and 29,430 men will die of the disease. The development and progression of prostate cancer is driven by androgens. Androgen Deprivation Therapy (ADT) has therefore been the cornerstone of treatment of advanced prostate cancer and is the first treatment intervention for Castration Sensitive Prostate Cancer (CSPC). Androgen Deprivation Therapies have included bilateral orchiectomy or Gonadotropin Releasing Hormone (GnRH) analogues, with or without first generation androgen receptor inhibitors such as CASODEX®: (Bicalutamide), NILANDRON® (Nilutamide) and EULEXIN® (Flutamide). The median duration of response is approximately 1 year and majority of these patients progress to Castration Resistant Prostate Cancer (CRPC). The mechanism of resistance to Androgen Deprivation Therapy (ADT) include reactivation of Androgen Receptor signaling through persistent adrenal androgen production, modification of the biologic characteristics of Androgen Receptors, intratumoral testosterone production and parallel steroidogenic pathways.

Two previously published trials, STAMPEDE and CHAARTED have shown that the addition of TAXOTERE® (Docetaxel) to Androgen Deprivaton Therapy as first line systemic therapy, significantly improved Overall Survival, among men with locally advanced or metastatic Castration Sensitive Prostate Cancer. This is presently the standard of care for appropriate patients with prostate cancer, who had not received prior hormone therapy. The barriers to chemo-hormonal therapy with TAXOTERE® include advanced patient age, poor Performance Status, comorbidities, patient preferences, as well as potential life threatening toxicities associated with TAXOTERE®.

ZYTIGA® is a selective, irreversible inhibitor of CYP 17A1 enzyme and decreases androgen biosynthesis in the testes, adrenal glands, and prostate-tumor tissue. Combining a CYP17A1 inhibitor such as ZYTIGA® with Androgen Deprivation Therapy is a more effective way of androgen depletion than with Orchiectomy or GnRH analogues alone. ZYTIGA® in combination with prednisone has been shown to significantly increase Overall Survival in patients with metastatic CRPC who had not received chemotherapy as well as those who had received previous chemotherapy with TAXOTERE®. Further, ZYTIGA® along with Prednisone has been shown to reduce tumor burden in men with high-risk, localized prostate cancer, receiving neoadjuvant therapy.

The current FDA approval was based on LATITUDE, a multinational, randomized, double-blind, placebo-controlled, phase III trial, in which the authors evaluated the clinical benefit of adding ZYTIGA® along with Prednisone to Androgen Deprivation Therapy (ADT), as compared with Androgen Deprivation Therapy and placebo, in patients with newly diagnosed, metastatic Castration Sensitive Prostate Cancer. In this study, 1199 newly diagnosed patients with high-risk metastatic prostate cancer were randomized to receive either ZYTIGA® along with Prednisone and ADT (N=597) or placebo and ADT (N=602). ZYTIGA® was administered at 1000 mg and Prednisone at 5 mg, both drugs given orally daily, and ADT consisted of a GnRH (Gonadotropin Releasing Hormone) analog. Eligible patients should not have received prior ADT and had at least 2 of 3 risk factors which included Gleason score 8 or greater, measurable visceral metastases or 3 or more bone lesions, all of which are associated with poor survival. The median age was 68 years and 98% of the enrolled patients had a Gleason score of 8 or more and had 3 or more sites of bone metastases. Both treatment groups were well balanced. The two Primary end points were Overall Survival and radiographic Progression Free Survival.

After a median follow-up of 30.4 months, at a planned interim analysis, the median Overall Survival was significantly longer in the ZYTIGA® group compared to the placebo group (Not Reached versus 34.7 months, HR=0.62; P<0.001). This meant a 38% reduction in the risk of death with the addition of ZYTIGA® and Prednisone to ADT compared with placebo and ADT. The median radiographic Progression Free Survival was 33 months in the ZYTIGA® group and 14.8 months in the placebo group (HR=0.47; P<0.001). This meant a 53% reduction in the risk of progression or death, with the addition of ZYTIGA® and Prednisone to ADT, compared with placebo and ADT. Further in the ZYTIGA® group, significantly better outcomes were observed in all Secondary end points and they included Time to pain progression, Time to next subsequent therapy for prostate cancer, Time to initiation of chemotherapy, and PSA progression (P<0.001 for all comparisons), along with Time to next symptomatic skeletal events (P=0.009). Based on these promising findings, the Independent Data and Safety Monitoring Committee recommended that the trial be unblinded and crossover be allowed for patients in the placebo group to receive ZYTIGA® and Prednisone along with ADT.

The authors concluded that the addition of ZYTIGA® along with Prednisone, to Androgen Deprivation Therapy, significantly increased Overall Survival and radiographic Progression Free Survival, in men with newly diagnosed, metastatic, Castration Sensitive Prostate Cancer. Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer. Fizazi K, Tran N, Fein L, et al. for the LATITUDE Investigators. N Engl J Med 2017; 377:352-360