Adding 6 months of androgen deprivation therapy to postoperative radiotherapy for prostate cancer: a comparison of short-course versus no androgen deprivation therapy in the RADICALS-HD randomised controlled trial

Background Previous evidence indicates that adjuvant, short-course androgen deprivation therapy (ADT) improves metastasis-free survival when given with primary radiotherapy for intermediate-risk and high-risk localised prostate cancer. However, the value of ADT with postoperative radiotherapy after radical prostatectomy is unclear. Methods RADICALS-HD was an international randomised controlled trial to test the efficacy of ADT used in combination with postoperative radiotherapy for prostate cancer. Key eligibility criteria were indication for radiotherapy after radical prostatectomy for prostate cancer, prostate-specific antigen less than 5 ng/mL, absence of metastatic disease, and written consent. Participants were randomly assigned (1:1) to radiotherapy alone (no ADT) or radiotherapy with 6 months of ADT (short-course ADT), using monthly subcutaneous gonadotropin-releasing hormone analogue injections, daily oral bicalutamide monotherapy 150 mg, or monthly subcutaneous degarelix. Randomisation was done centrally through minimisation with a random element, stratified by Gleason score, positive margins, radiotherapy timing, planned radiotherapy schedule, and planned type of ADT, in a computerised system. The allocated treatment was not masked. The primary outcome measure was metastasis-free survival, defined as distant metastasis arising from prostate cancer or death from any cause. Standard survival analysis methods were used, accounting for randomisation stratification factors. The trial had 80% power with two-sided α of 5% to detect an absolute increase in 10-year metastasis-free survival from 80% to 86% (hazard ratio [HR] 0·67). Analyses followed the intention-to-treat principle. The trial is registered with the ISRCTN registry, ISRCTN40814031, and ClinicalTrials.gov, NCT00541047. Findings Between Nov 22, 2007, and June 29, 2015, 1480 patients (median age 66 years [IQR 61–69]) were randomly assigned to receive no ADT (n=737) or short-course ADT (n=743) in addition to postoperative radiotherapy at 121 centres in Canada, Denmark, Ireland, and the UK. With a median follow-up of 9·0 years (IQR 7·1–10·1), metastasis-free survival events were reported for 268 participants (142 in the no ADT group and 126 in the short-course ADT group; HR 0·886 [95% CI 0·688–1·140], p=0·35). 10-year metastasis-free survival was 79·2% (95% CI 75·4–82·5) in the no ADT group and 80·4% (76·6–83·6) in the short-course ADT group. Toxicity of grade 3 or higher was reported for 121 (17%) of 737 participants in the no ADT group and 100 (14%) of 743 in the short-course ADT group (p=0·15), with no treatment-related deaths. Interpretation Metastatic disease is uncommon following postoperative bed radiotherapy after radical prostatectomy. Adding 6 months of ADT to this radiotherapy did not improve metastasis-free survival compared with no ADT. These findings do not support the use of short-course ADT with postoperative radiotherapy in this patient population

Duration of androgen deprivation therapy with postoperative radiotherapy for prostate cancer: a comparison of long-course versus short-course androgen deprivation therapy in the RADICALS-HD randomised trial

Background Previous evidence supports androgen deprivation therapy (ADT) with primary radiotherapy as initial treatment for intermediate-risk and high-risk localised prostate cancer. However, the use and optimal duration of ADT with postoperative radiotherapy after radical prostatectomy remains uncertain. Methods RADICALS-HD was a randomised controlled trial of ADT duration within the RADICALS protocol. Here, we report on the comparison of short-course versus long-course ADT. Key eligibility criteria were indication for radiotherapy after previous radical prostatectomy for prostate cancer, prostate-specific antigen less than 5 ng/mL, absence of metastatic disease, and written consent. Participants were randomly assigned (1:1) to add 6 months of ADT (short-course ADT) or 24 months of ADT (long-course ADT) to radiotherapy, using subcutaneous gonadotrophin-releasing hormone analogue (monthly in the short-course ADT group and 3-monthly in the long-course ADT group), daily oral bicalutamide monotherapy 150 mg, or monthly subcutaneous degarelix. Randomisation was done centrally through minimisation with a random element, stratified by Gleason score, positive margins, radiotherapy timing, planned radiotherapy schedule, and planned type of ADT, in a computerised system. The allocated treatment was not masked. The primary outcome measure was metastasis-free survival, defined as metastasis arising from prostate cancer or death from any cause. The comparison had more than 80% power with two-sided α of 5% to detect an absolute increase in 10-year metastasis-free survival from 75% to 81% (hazard ratio [HR] 0·72). Standard time-to-event analyses were used. Analyses followed intention-to-treat principle. The trial is registered with the ISRCTN registry, ISRCTN40814031, and ClinicalTrials.gov , NCT00541047 . Findings Between Jan 30, 2008, and July 7, 2015, 1523 patients (median age 65 years, IQR 60–69) were randomly assigned to receive short-course ADT (n=761) or long-course ADT (n=762) in addition to postoperative radiotherapy at 138 centres in Canada, Denmark, Ireland, and the UK. With a median follow-up of 8·9 years (7·0–10·0), 313 metastasis-free survival events were reported overall (174 in the short-course ADT group and 139 in the long-course ADT group; HR 0·773 [95% CI 0·612–0·975]; p=0·029). 10-year metastasis-free survival was 71·9% (95% CI 67·6–75·7) in the short-course ADT group and 78·1% (74·2–81·5) in the long-course ADT group. Toxicity of grade 3 or higher was reported for 105 (14%) of 753 participants in the short-course ADT group and 142 (19%) of 757 participants in the long-course ADT group (p=0·025), with no treatment-related deaths. Interpretation Compared with adding 6 months of ADT, adding 24 months of ADT improved metastasis-free survival in people receiving postoperative radiotherapy. For individuals who can accept the additional duration of adverse effects, long-course ADT should be offered with postoperative radiotherapy. Funding Cancer Research UK, UK Research and Innovation (formerly Medical Research Council), and Canadian Cancer Society

An Exploration Of Rural And Urban Kenyan Women\u27S Knowledge And Attitudes Regarding Breast Cancer And Breast Cancer Early Detection Measures

Many women in Kenya with breast cancer symptoms do not seek medical attention until their cancer is very advanced, leading to high mortality rates and a heavy cancer burden on the nation. In this study we employed eight focus groups with low- and middle-income rural and urban Kenyan women to explore their knowledge, attitudes, and behaviors concerning breast cancer and its early detection measures. Topics for discussion were derived from the components of the Health Belief Model (HBM). Findings revealed a huge divide between urban middle-income women and all other groups with respect to knowledge of breast cancer and early detection measures. In addition, women viewed breast cancer as a highly severe disease. Perceived benefits of early detection measures centered around preparing themselves for what was assumed to be inevitable death. © Taylor & Francis Group, LLC

A Semester-Long Joint Simulation Of The Development Of A Health Communication Campaign

This paper demonstrates that the effects of unanticipated monetary policy changes (shocks) on real estate investment trust (REIT) returns are asymmetric between the high- and low-variance regimes. A Markov regime-switching model with error correction terms is used to quantify the impact of monetary shocks on seven specialized REIT indices in a sample of daily returns from 1997 to 2008. The relationship between monetary shocks and REIT returns is negative, but this relationship is significant primarily during periods of high variance. Furthermore, monetary shocks have about twice as much effect on REITs as they do on the S&P 500 Index during high-variance regimes. This asymmetric response can be attributed to the Federal Reserve\u27s recession avoidance tactics, downward price rigidity, and the external financing premium. REITs are an important and independent test case for research into the impact of monetary shocks

The Effects Of Gender And Power Distance On Nonverbal Immediacy In Symmetrical And Asymmetrical Power Conditions: A Cross-Cultural Study Of Classrooms And Friendships

This study assessed the association of nonverbal immediacy, gender, and relational power in Brazil, Kenya, and the United States. Five hundred and eight students completed questionnaires on nonverbal immediacy of either their best friend (symmetrical power condition) or an instructor (asymmetrical power condition). Results revealed that women perceived more nonverbal immediacy than men in all cultures. Under symmetrical power conditions women were perceived to use more nonverbal immediacy than men, but under asymmetrical power conditions no gender difference emerged. Specific aspects of this association varied across cultures. Results partially supported cultural power as a moderating variable with regard to the use of non nonverbal immediacy. © 2011 National Communication Association

A Content Analysis Of Research On Religion And Spirituality In General Communication And Health Communication Journals

Little research has been conducted within the field of communication regarding the intersection of religious faith and health communication. One step toward addressing the existing gap in health communication literature is to establish an accurate picture of the present state of affairs. The purpose of this study was to describe publication patterns in communication journals over the past 10 years with respect to the intersection and faith and health communication. We conducted a content analysis on four broad-based communication journals that have been identified as central in the communication field, and two health communication journals. We present results regarding specific health conditions, nationalities, faith communities, channels of communication, domains of religion, and purposes of communication studied; methods used; trends in publication across time and communication journals; and comparison to other disciplines. © 2011 Copyright Taylor and Francis Group, LLC

Communication modes, Kenyan

This entry provides an introduction to Kenyan modes of communication. Collectivism is the key value that determines how Kenyans choose to communicate. Within the broader collectivist approach, relative status of the individuals involved and the purpose of communication in a given situation also affect the appropriate mode of communication. Indirectness, third party communication, judiciously withholding information, and use of metaphors, proverbs, and stories are characteristic of Kenyan interaction with persons of different status in society, or when conveying sensitive news. Directness is typical of close, horizontal personal relationships

The Effects Of Instructor Fear Appeals And Moral Appeals On Cheating-Related Attitudes And Behavior Of University Students

The ideal method for sperm selection during Intracytoplasmic sperm injection (ICSI) is still ill-defined. Identification of a viable spermatozoon amongst immotile spermatozoa for ICSI often becomes difficult. Ninety-six ICSI cycles were selected and divided into Group A (azoospermic, n=58) and Group B (complete asthenozoospermic, n=38). Oocytes having birefringent meiotic spindle and zona pellucida thickness \u3c20μm were selected for ICSI. Groups A and B were further divided into A1, A2 and B1, B2, respectively, based on the type of ICSI performed. In Group A1, a motile spermatozoon with normal morphology was injected into a metaphase-II (M-II) oocyte. In Group B1, spermatozoon showing coiling of tail following modified hypo-osmotic swelling test was injected into M-II oocytes. In Groups A2 and B2, ICSI was performed by injecting a spermatozoan with birefringent head. Pronuclear morphology, fertilisation rate, embryo grading and pregnancy rate were assessed. ICSI outcome measures were better in Group A2 than in Group A1 but were statistically insignificant. However, significantly higher percentage of Z1 and Z2 zygotes, Grade I and Grade II embryos and pregnancy rate were observed in Group B2 as compared to Group B1. Selection of birefringent spermatozoa shows promising results in asthenozoospermic men and men undergoing testicular sperm aspiration or extraction before ICSI. © 2012 Blackwell Verlag GmbH