Testosterone suppression: Impact of testosterone level on disease progression in advanced prostate cancer.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 46-46
Author(s):  
Shawn Dason ◽  
Justin Tong ◽  
Christopher Brian Allard ◽  
Bobby Shayegan
Keyword(s):  
Prostate Cancer ◽  
Disease Progression ◽  
Testosterone Level ◽  
Advanced Prostate Cancer ◽  
Risk Groups ◽  
Rank Test ◽  
Testosterone Levels ◽  
Baseline Characteristics ◽  
The Impact

46 Background: In patients with advanced prostate cancer, medical castration remains a mainstay of treatment. A testosterone level below 50 ng/dL has been previously accepted as an adequate level of androgen suppression and remains the benchmark level for clinical trials. However, there is mounting evidence that lower testosterone levels may be associated with improved clinical outcomes. We evaluated our cohort of patients with advanced prostate cancer to assess the impact of testosterone suppression on progression to castrate resistant prostate cancer (CRPC). Methods: Patient data was obtained from a prospective database of patients undergoing androgen deprivation therapy (ADT) at a tertiary centre from 2006-2011. A total of 39 patients were eligible for inclusion with at least 12 months follow-up. Patients were administered LHRH agonists or antagonist with testosterone and PSA assessments every 3 months. Patients were considered to have progressed to CRPC when there were at least 2 consecutive rises in PSA above nadir, clinical progression, or death from disease. Patients were stratified into two risk groups based on 6-month absolute and 1-year mean testosterone levels following initiation of ADT. Baseline characteristics between risk groups were compared using the Student’s t-test and chi-squared test. Probability of disease progression was assessed using the Kaplan-Meier method and compared using the log-rank test. Results: Median patient follow up was 2.3 years with 38% free of disease at last follow up. Patients with 6-month absolute testosterone less than 32 ng/dL had an increased time to CRPC (log rank p=0.06). Patients with 1-year mean testosterone less than 32 ng/dl had a significantly increased time to CRPC (log rank p=0.005). Patients did not differ significantly in their baseline characteristics. Conclusions: Adequate testosterone suppression during ADT may play a clinically significant role in delaying CRPC. While PSA levels are often used to assess for response to ADT, the current study suggests testosterone level in the first year following initiation of ADT may serve as an early predictor of disease progression.

Impact of concomitant prostate cancer therapy on efficacy and safety of relugolix versus leuprolide in men with advanced prostate cancer: Subgroup analysis from the phase III HERO study.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 106-106
Author(s):  
Daniel J. George ◽  
Neal D. Shore ◽  
Fred Saad ◽  
Michael Cookson ◽  
Daniel Saltzstein ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Sensitivity Analysis ◽  
Primary Endpoint ◽  
Subgroup Analysis ◽  
Advanced Prostate Cancer ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Concomitant Therapy ◽  
Testosterone Levels ◽  
The Impact

106 Background: In the phase 3 HERO study, the oral GnRH receptor antagonist, relugolix, demonstrated suppression of testosterone to castrate levels in 96.7% of patients, which was superior to leuprolide, and a 54% lower risk of major adverse cardiovascular events relative to leuprolide. To characterize the impact of concomitant prostate cancer treatments with the use of relugolix in advanced prostate cancer from the HERO study, a subgroup analysis for patients receiving various therapies was undertaken. Methods: The HERO study was designed to evaluate relugolix in men with advanced prostate cancer. Overall, 934 patients were randomized 2:1 to receive relugolix 120 mg orally once daily or leuprolide injections every 12 weeks for 48 weeks. In the setting of rising PSA, patients could receive enzalutamide (ENZ) or docetaxel (DOC) 2 months after study initiation. Assessments included sustained testosterone suppression to castrate levels (<50 ng/dL) through 48 weeks and safety parameters. Subgroups analyzed included patients with or without concomitant ENZ, DOC, and any radiation therapy (RT). A sensitivity analysis of the primary endpoint was performed excluding patients who received concomitant therapies that may affect testosterone. Results: Overall, 125 patients (13.4%) took at least one concomitant therapy that could impact testosterone levels. RT was received by 15.9% and 18.8% of patients in the relugolix and leuprolide groups, respectively. ENZ was the most frequently used therapy in the relugolix group (2.7%), with similar use in the leuprolide group (1.9%). DOC was used by 1.3% and 1.6% of patients in the relugolix and leuprolide groups, respectively. All other relevant concomitant therapy were used in <1% of population. The sensitivity analysis results indicated that use of these concomitant therapy that could affect testosterone levels did not impact the primary endpoint. Castration rates were similar with and without concomitant use of ENZ and DOC, or RT (table). No clinically relevant differences in adverse events were observed between patients with or without concomitant use of ENZ, DOC, or RT in either treatment group. Conclusions: While the numbers are small, treatment with relugolix was associated with a similar efficacy and safety profiles in patients who received concomitant administration of ENZ, DOC, or RT to that observed in patients not receiving those concomitant treatments. Clinical trial information: NCT03085095. [Table: see text]

scholarly journals Testosterone monitoring for men with advanced prostate cancer: Review of current practices and a survey of Canadian physicians

2017 ◽  
Vol 11 (6) ◽  
pp. 204 ◽  
Author(s):  
Bobby Shayegan ◽  
Frédéric Pouliot ◽  
Alan So ◽  
John Fernandes ◽  
Joseph Macri
Keyword(s):  
Prostate Cancer ◽  
Androgen Deprivation Therapy ◽  
Testosterone Level ◽  
Advanced Prostate Cancer ◽  
Standard Of Care ◽  
Androgen Deprivation ◽  
Testosterone Levels ◽  
Radiation Oncologists ◽  
Cancer Review ◽  
Hormone Sensitive

Androgen-deprivation therapy (ADT) is a standard of care in the treatment of advanced prostate cancer; however, testosterone monitoring practices for men undergoing ADT vary across Canada. Although a testosterone level of 1.7 nmol/L or lower has historically been defined as the accepted castrate level, newer assays with improved sensitivity have shown that both medical and surgical castration can suppress testosterone levels to below 0.7 nmol/L. This review explores the evidence supporting a redefinition of the castrate testosterone level as 0.7 nmol/L or lower, and presents results of a survey of testosterone monitoring practices among 153 Canadian urologists, uro-oncologists, and radiation oncologists who manage the treatment of men with hormone-sensitive prostate cancer.

scholarly journals Maximal testosterone suppression in the management of recurrent and metastatic prostate cancer

2017 ◽  
Vol 11 (1-2) ◽  
pp. 16 ◽  
Author(s):  
Laurence Klotz ◽  
Rodney H. Breau ◽  
Loretta L. Collins ◽  
Martin E. Gleave ◽  
Tom Pickles ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Testosterone Level ◽  
Metastatic Prostate Cancer ◽  
Specific Antigen ◽  
Androgen Deprivation ◽  
Castration Resistant Prostate Cancer ◽  
Laboratory Equipment ◽  
Testosterone Levels ◽  
Improved Outcomes ◽  
The Impact

Introduction: Testosterone suppression, or androgen-deprivation therapy (ADT), is an established treatment for recurrent and metastatic prostate cancer (PCa). Based on the accuracy and sensitivityof early assays (c. 1960–1970), the castrate testosterone level was set at ≤1.7 nmol/l. Improved sensitivity of testosterone assays shows that both surgical and medical castration can achieve levels <0.7 nmol/l. However, the clinical implications and importance of maximum testosterone suppression remains a subject of controversy. This evidence-based review assesses prospective and retrospectiveclinical data, linking maximum suppression of testosterone with improved outcomes from ADT.Methods: PubMed and conference proceedings were searched for studies assessing the impact of low testosterone on clinical outcomes from ADT. The key search terms included combinations of prostate cancer and testosterone, predictive/prognostic, and androgen deprivation. Results were limited to studies investigating the relationship between testosterone levels and clinical outcomes.Results: Both prospective and retrospective data support a relationship between testosterone levels below the historical standard of 1.7 nmol/l and improved outcomes. Eight studies showed significantimprovements in survival-related outcomes, with the majority of data supporting a testosterone level cutoff of ≤0.7 nmol/l.Conclusions: Tracking both testosterone and prostate-specific antigen (PSA) levels has significant clinical benefits, and the serum testosterone threshold of ≤0.7 nmol/l is a practical goal. The relativelevels of testosterone and PSA may indicate continued hormone responsiveness or progression toward castration-resistant prostate cancer (CRPC) and should, therefore, inform treatment strategy. Standardization of assay methods and clinical coordination to facilitate widespread access to state-of the art laboratory equipment is necessary to ensure accurate decision-making.

scholarly journals Oncological results of neoadjuvant chemohormonal therapy in patients with high and very high-risk prostate cancer

2020 ◽  
Vol 16 (1) ◽  
pp. 54-63
Author(s):  
M. V. Berkut ◽  
A. S. Artemjeva ◽  
S. A. Reva ◽  
S. S. Tolmachev ◽  
S. B. Petrov ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Specific Antigen ◽  
Risk Groups ◽  
Rank Test ◽  
Chemohormonal Therapy ◽  
Log Rank Test ◽  
Oncological Results ◽  
Very High

Tolsotogo St., Saint Petersburg 197022, RussiaBackground. Prostate cancer (PCa) of a high and very high risk is a potentially fatal disease that requires an active multimodal approach, including the use of neoadjuvant drug treatment. As option for this treatment is neoadjuvant chemohormonal therapy (NCHT) followed by radical prostatectomy (RPE). However, data on the oncological results of treatment of such patients are still limited and the role of neoadjuvant therapy in the treatment of high and very high-risk PCa remains not fully understood.Objective: to assess the oncological results of treatment patients with localized and locally advanced PCa of high and very high risk after NCHT. Materials and methods. This was a prospective randomized study: patients with PCa of high and very high-risk groups (prostate specific antigen levels (PSA) >20 ng/ml and/or Gleason score ³8 and/or clinical stage >T2c) were treated with RPE only (group RPE; n = 35) or NCHT followed by RPE (NCHT/RPE group; n = 36). The neoadjuvant course included the intravenous administration of docetaxel once every 21 days (75 mg/m2 up to 6 cycles) and the antagonist of the gonadotropin releasing hormone degarelix according to the standard scheme (6 subcutaneous injections every 28 days). After a follow-up examination evaluating the result of the neoadjuvant regimen, patients underwent RPE with extanded lymphadenectomy.Results. A mean follow-up was 37.08 ± 20.46 months. A statistically significant reduction of prostate specific antigen >50 % post-chemohormonal therapy was observed in all 36 cases. Lower postoperative stage was noticed in 38.5 % in NCHT/RPE group compared with 2.7 % in RPE group. Similarly, positive surgical margin rate was higher in group without neoadjuvant therapy – 40 and 25 % (RPE group). Cancerspecific survival was 97.2 % in NCHT/RPE group and 87.56 % in the RP group (p = 0.037), cancer specific survival rate – 91.4 % and 97.2 % respectively (log-rank test p = 0.22). At the same time, no statistically significant differences were obtained in 3-year recurrence free survival between groups: 38.8 % in NCHT/RPE group versus 43.6 % in the RPE group (log-rank test p = 0.36).Conclusion. Conducting NCHT before RPE is a safe and effective strategy in patients with PCa of high and very high risk groups and could improve oncological results.

scholarly journals Understanding and responding to COVID-19 in Wales: protocol for a privacy-protecting data platform for enhanced epidemiology and evaluation of interventions

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e043010
Author(s):  
Jane Lyons ◽  
Ashley Akbari ◽  
Fatemeh Torabi ◽  
Gareth I Davies ◽  
Laura North ◽  
...  
Keyword(s):  
Policy Development ◽  
Healthcare Utilisation ◽  
Population Data ◽  
Population Level ◽  
Risk Groups ◽  
Service Utilisation ◽  
Natural Experiments ◽  
Spread Of Infection ◽  
The Impact

IntroductionThe emergence of the novel respiratory SARS-CoV-2 and subsequent COVID-19 pandemic have required rapid assimilation of population-level data to understand and control the spread of infection in the general and vulnerable populations. Rapid analyses are needed to inform policy development and target interventions to at-risk groups to prevent serious health outcomes. We aim to provide an accessible research platform to determine demographic, socioeconomic and clinical risk factors for infection, morbidity and mortality of COVID-19, to measure the impact of COVID-19 on healthcare utilisation and long-term health, and to enable the evaluation of natural experiments of policy interventions.Methods and analysisTwo privacy-protecting population-level cohorts have been created and derived from multisourced demographic and healthcare data. The C20 cohort consists of 3.2 million people in Wales on the 1 January 2020 with follow-up until 31 May 2020. The complete cohort dataset will be updated monthly with some individual datasets available daily. The C16 cohort consists of 3 million people in Wales on the 1 January 2016 with follow-up to 31 December 2019. C16 is designed as a counterfactual cohort to provide contextual comparative population data on disease, health service utilisation and mortality. Study outcomes will: (a) characterise the epidemiology of COVID-19, (b) assess socioeconomic and demographic influences on infection and outcomes, (c) measure the impact of COVID-19 on short -term and longer-term population outcomes and (d) undertake studies on the transmission and spatial spread of infection.Ethics and disseminationThe Secure Anonymised Information Linkage-independent Information Governance Review Panel has approved this study. The study findings will be presented to policy groups, public meetings, national and international conferences, and published in peer-reviewed journals.

scholarly journals Cognitive decline in patients with prostate cancer: study protocol of a prospective cohort, NEON-PC

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e043844
Author(s):  
Natalia Araujo ◽  
Samantha Morais ◽  
Ana Rute Costa ◽  
Raquel Braga ◽  
Ana Filipa Carneiro ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Cognitive Decline ◽  
Cognitive Performance ◽  
Androgen Deprivation Therapy ◽  
Survival Rates ◽  
Cardiovascular Complications ◽  
Androgen Deprivation ◽  
High Survival ◽  
The Impact

IntroductionProstate cancer is the most prevalent oncological disease among men in industrialised countries. Despite the high survival rates, treatments are often associated with adverse effects, including metabolic and cardiovascular complications, sexual dysfunction and, to a lesser extent, cognitive decline. This study was primarily designed to evaluate the trajectories of cognitive performance in patients with prostate cancer, and to quantify the impact of the disease and its treatments on the occurrence of cognitive decline.MethodsParticipants will be recruited from two main hospitals providing care to approximately half of the patients with prostate cancer in Northern Portugal (Portuguese Institute of Oncology of Porto and São João Hospital Centre), and will comprise a cohort of recently diagnosed patients with prostate cancer proposed for different treatment plans, including: (1) radical prostatectomy; (2) brachytherapy and/or radiotherapy; (3) radiotherapy in combination with androgen deprivation therapy and (4) androgen deprivation therapy (with or without chemotherapy). Recruitment began in February 2018 and is expected to continue until the first semester of 2021. Follow-up evaluations will be conducted at 1, 3, 5, 7 and 10 years. Sociodemographic, behavioural and clinical characteristics, anxiety and depression, health literacy, health status, quality of life, and sleep quality will be assessed. Blood pressure and anthropometrics will be measured, and a fasting blood sample will be collected. Participants’ cognitive performance will be evaluated before treatments and throughout follow-up (Montreal Cognitive Assessment and Cube Test as well as Brain on Track for remote monitoring). All participants suspected of cognitive impairment will undergo neuropsychological tests and clinical observation by a neurologist.Ethics and disseminationThe study was approved by the Ethics Committee of the hospitals involved. All participants will provide written informed consent, and study procedures will be developed to ensure data protection and confidentiality. Results will be disseminated through publication in peer-reviewed journals and presentation in scientific meetings.

The Efficacy of Etoposide-Based Therapy in Adult Secondary Hemophagocytic Lymphohistiocytosis

2021 ◽  
pp. 1-9
Author(s):  
Leonard Naymagon ◽  
Douglas Tremblay ◽  
John Mascarenhas
Keyword(s):  
Hemophagocytic Lymphohistiocytosis ◽  
Proportional Hazards ◽  
Multivariable Analysis ◽  
Cox Proportional Hazards ◽  
Rank Test ◽  
Kaplan Meier ◽  
Hazard Ratios ◽  
Significant Difference ◽  
The Impact

Data supporting the use of etoposide-based therapy in hemophagocytic lymphohistiocytosis (HLH) arise largely from pediatric studies. There is a lack of comparable data among adult patients with secondary HLH. We conducted a retrospective study to assess the impact of etoposide-based therapy on outcomes in adult secondary HLH. The primary outcome was overall survival. The log-rank test was used to compare Kaplan-Meier distributions of time-to-event outcomes. Multivariable Cox proportional hazards modeling was used to estimate adjusted hazard ratios (HRs) with 95% confidence intervals (CIs). Ninety adults with secondary HLH seen between January 1, 2009, and January 6, 2020, were included. Forty-two patients (47%) received etoposide-based therapy, while 48 (53%) received treatment only for their inciting proinflammatory condition. Thirty-three patients in the etoposide group (72%) and 32 in the no-etoposide group (67%) died during follow-up. Median survival in the etoposide and no-etoposide groups was 1.04 and 1.39 months, respectively. There was no significant difference in survival between the etoposide and no-etoposide groups (log-rank <i>p</i> = 0.4146). On multivariable analysis, there was no association between treatment with etoposide and survival (HR for death with etoposide = 1.067, 95% CI: 0.633–1.799, <i>p</i> = 0.8084). Use of etoposide-based therapy was not associated with improvement in outcomes in this large cohort of adult secondary HLH patients.

scholarly journals Effect of prior cancer on survival outcomes for patients with advanced prostate cancer

BMC Urology ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yechen Wu ◽  
Xi Chen ◽  
Duocheng Qian ◽  
Wei Wang ◽  
Yiping Zhang ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Outcomes ◽  
Cancer Diagnosis ◽  
Advanced Prostate Cancer ◽  
Lymphocytic Leukemia ◽  
Cancer History ◽  
Non Hodgkin Lymphoma ◽  
Kaplan Meier ◽  
History Of ◽  
The Impact

Abstract Background A history of prior cancer commonly results in exclusion from cancer clinical trials. However, whether a prior cancer history has an adversely impact on clinical outcomes for patients with advanced prostate cancer (APC) remains largely unknown. We therefore aimed to investigate the impact of prior cancer history on these patients. Methods We identified patients with advanced prostate cancer diagnosed from 2004 to 2010 in the Surveillance, Epidemiology, and End Results (SEER) database. Propensity score matching (PSM) was used to balance baseline characteristics. Kaplan–Meier method and the Cox proportional hazard model were utilized for survival analysis. Results A total of 19,772 eligible APC patients were included, of whom 887 (4.5 %) had a history of prior cancer. Urinary bladder (19 %), colon and cecum (16 %), melanoma of the skin (9 %) malignancies, and non-hodgkin lymphoma (9 %) were the most common types of prior cancer. Patients with a history of prior cancer had slightly inferior overall survival (OS) (AHR = 1.13; 95 % CI [1.02–1.26]; P = 0.017) as compared with that of patients without a prior cancer diagnosis. Subgroup analysis further indicated that a history of prior cancer didn’t adversely impact patients’ clinical outcomes, except in patients with a prior cancer diagnosed within 2 years, at advanced stage, or originating from specific sites, including bladder, colon and cecum, or lung and bronchus, or prior chronic lymphocytic leukemia. Conclusions A large proportion of APC patients with a prior cancer history had non-inferior survival to that of patients without a prior cancer diagnosis. These patients may be candidates for relevant cancer trials.

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