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Thread: (L) Hormone Therapy

  1. #61
    Androgen deprivation therapy and Gleason grade: unravelling implications on survival
    [2019, Editorial]


    The efficacy of concurrent androgen deprivation therapy (ADT) with radiation therapy among patients with highrisk prostate cancer is well documented. A meta-analysis
    by Kishan et al. (1) compared the effect of ADT duration on survival in patients with Gleason grade group (GGG) 4 and GGG 5 prostate cancer receiving radiation therapy by performing an individual patient-level network metaanalysis with data from six randomized controlled trials. Due to the significant adverse effects of ADT, efforts have been made to assess the efficacy of shorter ADT durations. The present study investigated if the effect of ADT duration on survival differed between patients with GGG 4
    and GGG 5 disease.
    Paper discussed:

    Association of Gleason Grade With Androgen Deprivation Therapy Duration and Survival Outcomes A Systematic Review and Patient-Level Meta-analysis [2019]


    Key Points

    Question Do Gleason grade group (GG) 4 (formerly Gleason score 8 ) and GG 5 (formerly Gleason score 9-10) prostate cancers respond differently to increasing durations of androgen deprivation therapy (ADT) with radiotherapy?

    Findings In this systematic review and meta-analysis of 992 patients with GG 4 to 5 disease, short-term ADT and long-term ADT only improved overall survival among patients with GG 4 disease, and lifelong ADT only improved overall survival in patients with GG 5 disease.

    Meaning Longer durations of ADT improved outcomes in GG 4 and GG 5 disease, with different optimal durations; strategies to maintain the efficacy of ADT while minimizing its duration (potentially with enhanced potency agents) should be investigated.

    Importance Androgen deprivation therapy (ADT) improves survival outcomes in patients with high-risk prostate cancer (PCa) treated with radiotherapy (RT). Whether this benefit differs between patients with Gleason grade group (GG) 4 (formerly Gleason score 8 ) and GG 5 (formerly Gleason score 9-10) disease remains unknown.

    Objective To determine whether the effectiveness of ADT duration varies between patients with GG 4 vs GG 5 PCa.

    Design, Setting, and Participants Traditional and network individual patient data meta-analyses of 992 patients (593 GG 4 and 399 GG 5) who were enrolled in 6 randomized clinical trials were carried out.

    Main Outcomes and Measures Multivariable Cox proportional hazard models were used to obtain hazard ratio (HR) estimates of ADT duration effects on overall survival (OS) and distant metastasis-free survival (DMFS). Cause-specific competing risk models were used to estimate HRs for cancer-specific survival (CSS). The interaction of ADT with GS was incorporated into the multivariable models. Traditional and network meta-analysis frameworks were used to compare outcomes of patients treated with RT alone, short-term ADT (STADT), long-term ADT (LTADT), and lifelong ADT.

    Results Five hundred ninety-three male patients (mean age, 70 years; range, 43-88 years) with GG 4 and 399 with GG 5 were identified. Median follow-up was 6.4 years. Among GG 4 patients, LTADT and STADT improved OS over RT alone (HR, 0.43; 95% CI, 0.26-0.70 and HR, 0.59; 95% CI, 0.38-0.93, respectively; P = .03 for both), whereas lifelong ADT did not (HR, 0.84; 95% CI, 0.54-1.30; P = .44). Among GG 5 patients, lifelong ADT improved OS (HR, 0.48; 95% CI, 0.31-0.76; P = .04), whereas neither LTADT nor STADT did (HR, 0.80; 95% CI, 0.45-1.44 and HR, 1.13; 95% CI, 0.69-1.87; P = .45 and P = .64, respectively). Among all patients, and among those receiving STADT, GG 5 patients had inferior OS compared with GG 4 patients (HR, 1.25; 95% CI, 1.07-1.47 and HR, 1.40; 95% CI, 1.05-1.88, respectively; P = .02). There was no significant OS difference between GG 5 and GG 4 patients receiving LTADT or lifelong ADT (HR, 1.21; 95% CI, 0.89-1.65 and HR, 0.85; 95% CI, 0.53-1.37; P = .23 and P = .52, respectively).

    Conclusions and Relevance These data suggest that prolonged durations of ADT improve survival outcomes in both GG 4 disease and GG 5 disease, albeit with different optimal durations. Strategies to maintain the efficacy of ADT while minimizing its duration (potentially with enhanced potency agents) should be investigated.

  2. #62
    Cancer-related symptoms, mental well-being, and psychological distress in men diagnosed with prostate cancer treated with androgen deprivation therapy
    [2019, Full Text]



    There are known associations between treatment of prostate cancer (PCa) involving Androgen Deprivation Therapy (ADT) and psychological and physical side effects. We investigate the associations between cancer-related symptoms, health-related quality of life (HRQL), and poor psychological outcomes in men whose treatment for PCa involved ADT.

    A cross-sectional postal questionnaire was administered to UK men 18–42 months post diagnosis of PCa. Men completed items on functional outcomes using the Expanded Prostate Cancer Index Composite (EPIC-26), EuroQol-5D (EQ-5D), and the European Organisation for Research and Treatment of Cancer (EORTC) Fatigue subscale. Psychological outcomes (mental well-being and psychological distress) were assessed using the Short Warwick–Edinburgh Mental Well-being Scale (SWEMWBS) and the Kessler 6-item scale (K6), respectively. Associations between explanatory variables and psychological outcomes were assessed using stepped logistic regression.

    13,097 men treated with ADT completed a questionnaire. A minority of men reported poor mental well-being (15.5%) or severe psychological distress (6.6%). After controlling for sociodemographic and clinical variables, reporting clinically significant fatigue was strongly associated with severe psychological distress (OR 9.92; 95% CI 7.63 to 12.89) and poor well-being (OR 3.86; 95% CI 3.38 to 4.42). All cancer-related symptoms and HRQL variables were associated with both psychological outcomes.

    While the majority of men treated with ADT did not report poor psychological outcomes, a small proportion reported severe problems. Clinically significant fatigue was demonstrated as a possible indicator of poor outcomes. Healthcare systems need to have clear protocols in place which specifically and routinely target psychological distress and fatigue.

  3. #63
    Body Image Issues and Attitudes Toward Exercise amongst Men Undergoing Androgen Deprivation Therapy (ADT) Following Diagnosis of Prostate Cancer



    Androgen Deprivation Therapy (ADT) is an established treatment for prostate cancer (PCa), but its side-effects can affect body appearance and functioning. However, research into the impact of ADT on body image is limited. Exercise can help patients to counterbalance some side-effects, potentially improving body image too. However, adherence to exercise recommendations is low. Therefore, we explored body image after ADT and attitudes towards exercise.

    Twenty two semi-structured interviews were conducted with PCa patients receiving ADT (Mage = 67.9 yo, SD = 9.99).

    Participants expressed appearance dissatisfaction focusing on body feminization. Participants exercised to counterbalance ADT side-effects and improve mood. Exercise also helped them to re-establish a sense of control over their body and experience a sense of achievement. However, some men described being worried that their appearance and physical performance would be judged by others, so they often exercised alone or gave up exercise. Time management and fatigue were also identified as exercise barriers.

    These findings highlight the need to further investigate body image concerns and exercise barriers in PCa patients undergoing ADT. These results could also inform support groups and health care professionals on the topic. However, further research should explore the most effective and acceptable ways to provide support to PCa patients on body image issues.

  4. #64
    Early versus deferred standard androgen suppression therapy for advanced hormone-sensitive prostate cancer



    Standard androgen suppression therapy (AST) using surgical or medical castration is considered a mainstay of advanced hormone‐sensitive prostate cancer treatment. AST can be initiated early when disease is asymptomatic or deferred when patients suffer symptoms of disseminated prostate cancer.

    To assess the effects of early versus deferred standard AST for advanced hormone‐sensitive prostate cancer.

    Search methods
    For this Cochrane Review update, we performed a comprehensive search of multiple databases (CENTRAL, MEDLINE, Embase, Web of Science; last searched November 2018 ) and two clinical trial registers, with no restrictions on the language of publication or publication status. We also searched bibliographies of included studies and conference proceedings (last searched January 2019).

    Selection criteria
    We included all randomised controlled trials (RCTs) with a direct comparison of early versus deferred standard AST. We excluded all other study designs. Participants included had advanced hormone‐sensitive prostate cancer receiving surgical or medical castration.

    Data collection and analysis
    Two review authors independently classified studies and abstracted data. The primary outcomes were time to death of any cause and serious adverse events. Secondary outcomes were time to disease progression, time to death from prostate cancer, adverse events and quality of life. We performed statistical analyses using a random‐effects model and assessed the certainty of evidence according to GRADE. We performed subgroup analyses for advanced but non‐metastatic disease (T2‐4/N+ M0), metastatic disease (M1), and prostate‐specific antigen (PSA) relapse.

    Main results
    We identified seven new RCTs since publication of the original review in 2002. In total, we included 10 RCTs.

    Primary outcomes
    Early AST probably reduces the risk of death from any cause over time (hazard ratio (HR) 0.82, 95% confidence interval (CI) 0.75 to 0.90; moderate‐certainty evidence; 4767 participants). This corresponds to 57 fewer deaths (95% CI 80 fewer to 31 fewer) per 1000 participants at 5 years for the moderate risk group and 23 fewer deaths (95% CI 32 fewer to 13 fewer) per 1000 participants at 5 years in the low risk group. We downgraded for study limitations. Early versus deferred AST may have little or no effect on serious adverse events (risk ratio (RR) 1.05, 95% CI 0.95 to 1.16; low‐certainty evidence; 10,575 participants) which corresponds to 6 more serious adverse events (6 fewer to 18 more) per 1000 participants. We downgraded the certainty of evidence for study limitations and selective reporting.

    Secondary outcomes
    Early AST probably reduces the risk of death from prostate cancer over time (HR 0.69, 95% CI 0.57 to 0.84; moderate‐certainty evidence). This corresponds to 62 fewer prostate cancer deaths per 1000 (95% CI 87 fewer to 31 fewer) at 5 years for the moderate risk group and 24 fewer death from prostate cancer (95% CI 34 fewer to 12 fewer) per 1000 men at 5 years in the low risk group. We downgraded the certainty of evidence for study limitations.

    Early AST may decrease the rate of skeletal events (RR 0.37, 95% CI 0.17 to 0.80; low‐certainty evidence) corresponding to 23 fewer skeletal events per 1000 (95% CI 31 fewer to 7 fewer). We downgraded for study limitations and imprecision. It may also increase fatigue (RR 1.41, 95% CI 1.23 to 1.62; low‐certainty evidence), corresponding to 31 more men with this complaint per 1000 (95% CI 18 more to 48 more). We downgraded for study limitations and imprecision. It may increase the risk of heart failure (RR 1.90, 95% CI 1.09 to 3.33; low‐certainty evidence) corresponding to 27 more events per 1000 (95% CI 3 more to 69 more). We downgraded the certainty of evidence for study limitations and imprecision.

    Global quality of life is probably similar after two years as assessed with the EORTC QLQ‐C30 (version 3.0) questionnaire (mean difference −1.56, 95% CI −4.50 to 1.38; moderate‐certainty evidence) with higher scores reflecting better quality of life. We downgraded the certainty of evidence for study limitations.

    Authors' conclusions
    Early AST probably extends time to death of any cause and time to death from prostate cancer. It may slightly decrease the rate of skeletal events. Rates of serious adverse events and quality of life may be similar. It may increase fatigue and may increase the risk of heart failure. Better quality trials would be particularly important to better understand the outcomes related to possible treatment‐related harm, for which we only found low‐certainty evidence.

  5. #65
    The ABCs of Androgen Deprivation Therapy - 2019 Prostate Cancer Patient Conference
    [2019, Video Presentation]


    Dr. Eric Small, Professor of Medicine; Urology; and Chief, Department of Medicine/Division of Hematology/Oncology, UCSF. Recorded on 06/08/2019.

    Good primer on the basics and the three ADT treatment algorithms.

    Flagged by Forum Brother garyi.
    Last edited by DjinTonic; 06-24-2019 at 04:59 PM.

  6. #66
    Association Between Androgen Deprivation Therapy Use and Diagnosis of Dementia in Men With Prostate Cancer [2019, Full Text]


    Flagged by Forum Brother Skipper Chuck:

    Key Points

    Question Is androgen deprivation therapy exposure associated with dementia among elderly patients with prostate cancer?

    Findings In this cohort study of 154 089 elderly men with prostate cancer, androgen deprivation therapy exposure was associated with subsequent diagnosis of Alzheimer disease or dementia over a follow-up period of at least 10 years.

    Meaning Clinicians must carefully weigh the long-term risks and benefits of exposure to androgen deprivation therapy in patients with a prolonged life expectancy and stratify patients by dementia risk prior to androgen deprivation therapy initiation.

    Importance The association between androgen deprivation therapy (ADT) exposure and dementia is uncertain.

    Objective To analyze the association between ADT exposure and diagnosis of Alzheimer disease or dementia among elderly men with prostate cancer.

    Design, Setting, and Participants This retrospective cohort study used data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results–Medicare linked database. Participants were 154 089 elderly men newly diagnosed with prostate cancer between 1996 and 2003. The analyses were conducted between November 1, 2018, and December 31, 2018.

    Exposure Androgen deprivation therapy.

    Main Outcomes and Measures Patients receiving ADT within 2 years of prostate cancer diagnosis were identified. Survival analysis was used to determine the association between ADT exposure and diagnosis of Alzheimer disease or dementia in the follow-up period. Propensity score and instrumental variable approaches were used to minimize measured and unmeasured selection bias. The association by dose of ADT was also examined.

    Results Of the 295 733 men diagnosed with prostate cancer between 1996 and 2003, 154 089 met the study criteria. Of these, 62 330 (mean [SD] age, 76.0 [6.0] years) received ADT within 2 years of prostate cancer diagnosis, and 91 759 (mean [SD] age, 74.3 [6.0] years) did not receive ADT. Mean (SD) follow-up was 8.3 (4.7) years. Exposure to ADT, compared with no ADT exposure, was associated with a diagnosis of Alzheimer disease (13.1% vs 9.4%; difference, 3.7%; 95% CI, 3.3%-3.9%; P < .001; hazard ratio [HR], 1.14; 95% CI, 1.10-1.18 ) and dementia (21.6% vs 15.8%; difference, 5.8%; 95% CI, 5.4%-6.2%; P < .001; HR, 1.20; 95% CI, 1.17-1.24). For 1 to 4 doses of ADT, the HR was 1.19 (95% CI, 1.15-1.24) for Alzheimer disease and 1.19 (95% CI, 1.15-1.23) for dementia. For 5 to 8 doses of ADT, the HR was 1.28 (95% CI, 1.22-1.35) for Alzheimer disease and 1.24 (95% CI, 1.19-1.29) for dementia. For more than 8 doses of ADT, the HR was 1.24 (95% CI, 1.16-1.34) for Alzheimer disease and 1.21 (95% CI, 1.15-1.28 ) for dementia. The number needed to harm was 18 patients (95% CI, 17-19 patients) and 10 patients (95% CI, 9.5-11 patients) for Alzheimer disease and dementia, respectively.

    Conclusions and Relevance Among elderly patients with prostate cancer, ADT exposure was associated with subsequent diagnosis of Alzheimer disease or dementia over a follow-up period of at least 10 years.
    From the Full Text:


    In summary, our population-based study spanning 10 years or more following the diagnosis of prostate cancer shows that exposure to ADT was associated with increased hazard of both Alzheimer disease and dementia among elderly fee-for-service Medicare beneficiaries with prostate cancer. The list of effective ADT agents has recently grown with the addition of androgen synthesis inhibitors and second-generation antiandrogens. Furthermore, data are accumulating for the use of such agents earlier in the course of disease progression. Our results suggest that clinicians need to carefully weigh the long-term risks and benefits of exposure to ADT in patients with a prolonged life expectancy and stratify patients based on dementia risk prior to ADT initiation.

  7. #67
    Oncological safety of testosterone replacement therapy in prostate cancer survivors after definitive local therapy: A systematic literature review and meta-analysis



    To evaluate the association between testosterone replacement therapy (TRT) in prostate cancer (CaP) patients who underwent definitive local therapy with curative intent with biochemical recurrence (BCR).

    A literature search using PubMed, Scopus, Web of Science, and Cochrane Library was conducted on November 2018 to identify relevant studies according to the Preferred Reporting Items for Systematic Review and Meta Analysis guidelines. The pooled BCR rate in CaP men treated with TRT after definitive local therapy with curative intent was calculated using a random effects model.

    Twenty-one studies were eligible. The overall pooled BCR rate was 0.01 (95%CI 0.00-0.02) suggesting a lack of association between TRT and BCR; there was no heterogeneity among included studies (I2 = 24.34%, P = 0.15). In subgroup analyses, pooled BCR rates were 0.00 (95%CI 0.00-0.02) in patients treated with radical prostatectomy and 0.02 (95%CI 0.00-0.04) in patients treated with external beam radiation therapy, brachytherapy, cryotherapy, or high intensity focused ultrasound; there was no heterogeneity in the subgroup analyses (I2 = 19.88%, P = 0.18 ).

    In this systematic review and meta-analysis, we did not observe higher rate of BCR after TRT for nonmetastatic CaP patients after definitive local therapy. Based on these data, others and we have outlined a phase I/II trial assessing the safety and benefits of TRT in select men with secondary symptomatic hypogonadism who have no active disease after definitive local CaP therapy with curative intent.

  8. #68
    Prognostic value of testosterone during androgene deprivation therapy
    [2019, Full Text in French]



    INTRODUCTION:The concept of intermittent androgen deprivation therapy (IADT) for prostate cancer (PCa) was introduced in order to improve treatment tolerance with the same carcinological efficiency as continuous androgen deprivation therapy (CADT). Furthermore, studies have shown that PCa prognosis during CADT was correlated to the extent of testosterone collapse. The aim of this study was to assess the link between testosterone levels at the end of the first off-treatment phase and time to occurrence of castrate-resistant prostate cancer. METHODS:We retrospectively analyzed the files of 69 patients having undergone IADT. Intermittence was offered to the patients showing PSA<4ng/mL after at least six months of androgen deprivation therapy (ADT) using a LHRH analog. CRPC was defined according to the AFU oncological guidelines. Patients were sorted into three groups according to their testosterone levels at the end of the first off-treatment phase T<0.5ng/mL, 0.5<T<3.4ng/mL and T>3.4ng/mL. CRPC free-survival, metastasis-free survival and overall survival as well as adverse events frequency were compared between the groups. The impact of initial ADT duration on CRPC occurrence, mean off-treatment phase duration and IADT duration was also studied. RESULTS:Testosterone levels at the end of the first and second off-treatment phases were not linked to time to CRPC occurence (p=0.5), mestastasis occurence (p=0.4) or death (p=0.3). It was associated neither with adverse effects frequency (p=0.2) nor with cancer-related complications (p=0.6). Initial ADT duration was not linked to CRPC occurrence (p=0.6), mean off-treatment phase duration (p=0.5) or mean IADT duration (p=0.6). CONCLUSION:This study did not show any link between testosterone levels at the end of the first off-treatment phase (before reintroducing ADT) and overall survival, metastasis-free survival and CRPC-free survival. Likewise, it was not associated with the frequency of adverse events or cancer-related complications. Initial ADT duration was not linked to CRPC occurrence or IADT chronological parameters.

  9. #69
    How Are Patients With Prostate Cancer Managing Androgen Deprivation Therapy Side Effects?


    The use of androgen deprivation therapy (ADT) for the treatment of prostate cancer is efficacious for treating advanced prostate cancer, but is also associated with numerous side effects. Physical and psychological side effects are often distressing and notable causes of non-compliance among patients.1 Despite this, there appears to be a great deal of variability in the level of education patients receive on management strategies for ADT side effects. By providing patients with knowledge about various side effects and equipping them with various management strategies, compliance with therapy can be increased.

  10. #70
    Safety of testosterone therapy in men with prostate cancer
    [2019, Review]



    Introduction: The use of testosterone therapy (TTh) in men with prostate cancer (PCa) is relatively new, and controversial, due to the longstanding maxim that TTh is contraindicated in men with PCa. Scientific advances have prompted a reevaluation of the potential role for TTh in men with PCa, particularly as TTh has been shown to provide important symptomatic and general health benefits to men with testosterone deficiency (TD), including many men with PCa who may expect to live 30-50 years after diagnosis.

    Areas covered: This review outlines the historical underpinnings of the historical belief that TTh “fuels” PCa and the experimental and clinical studies that have radically altered this view, including description of the saturation model. The authors review studies of TTh in men with PCa following radical prostatectomy and radiation therapy, in men on active surveillance, and in men with advanced or metastatic PCa.

    Expert opinion: TTh provides important symptomatic and overall health benefits for men with PCa who have TD. Although more safety studies are needed, TTh is a reasonable therapeutic option for men with low-risk PCa after surgery or radiation. Data in men on active surveillance are limited, but initial reports are reassuring.
    Article highlights

    • Many men with a history of prostate cancer suffer from testosterone deficiency.
    • Testosterone therapy in these men improves symptoms and confers significant health benefits, including improved sexual function, increased energy and sense of wellbeing, loss of fat mass and gain in lean mass, resolution of anemia, and increased bone mineral density.
    • Although no large, long-term, controlled studies have yet been performed to provide definitive evidence regarding the safety of testosterone therapy in men with prostate cancer, the available data is reassuring.
    • Testosterone therapy may be reasonably offered to symptomatic men with testosterone deficiency who have low-risk disease after treatment for localized prostate cancer with surgery or radiation.
    • Testosterone therapy in men on active surveillance is less well established, however, several initial reports have shown progression rates comparable to those seen in men who did not receive testosterone therapy.
    • New clinical trial data suggests there may even be a therapeutic role for testosterone therapy in men with advanced prostate cancer.


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