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

Shayegan, Bobby; Pouliot, Frédéric; So, Alan; Fernandes, John; Macri, Joseph

doi:10.5489/cuaj.4539

Cited by 9 publications

(13 citation statements)

References 41 publications

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“…Our data thus show that intrapatient intermeasurement variability is about 25%, which is much less than the overestimation of testosterone levels by IA when testosterone is >0.7 nM. These results suggest that with a testosterone level measurement by IA >0.7 nM, confirmation by either MS or an IA method validated at low testosterone levels is more important than repeating the sampling later as suggested previously (15).…”

Section: Discussionsupporting

confidence: 79%

“…Therefore castrate testosterone levels were defined as <1.7 nM; despite this, surgical castration achieves levels of testosterone around 0.7 nM (11). Recent studies have suggested that testosterone levels <0.7 nM under ADT are associated rather with a longer time to castration-resistant prostate cancer (CRPC) or death compared to higher testosterone levels (4, 12, 13, 14, 15, 16, 17). Contemporary electrochemiluminescent immunoassay methods have a lower LLOQ (around 0.4 nM), thus lower castration testosterone levels are now targeted (<0.7 nM) (10).…”

Section: Introductionmentioning

confidence: 99%

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Discordance between testosterone measurement methods in castrated prostate cancer patients

Rouleau

Lemire

Déry

et al. 2019

Endocrine Connections

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Failure to suppress testosterone below 0.7 nM in castrated prostate cancer patients is associated with poor clinical outcomes. Testosterone levels in castrated patients are therefore routinely measured. Although mass spectrometry is the gold standard used to measure testosterone, most hospitals use an immunoassay method. In this study, we sought to evaluate the accuracy of an immunoassay method to measure castrate testosterone levels, with mass spectrometry as the reference standard. We retrospectively evaluated a cohort of 435 serum samples retrieved from castrated prostate cancer patients from April to September 2017. No follow-up of clinical outcomes was performed. Serum testosterone levels were measured in the same sample using liquid chromatography coupled with tandem mass spectrometry and electrochemiluminescent immunoassay methods. The mean testosterone levels were significantly higher with immunoassay than with mass spectrometry (0.672 ± 0.359 vs 0.461 ± 0.541 nM; P < 0.0001). Half of the samples with testosterone ≥0.7 nM assessed by immunoassay were measured <0.7 nM using mass spectrometry. However, we observed that only 2.95% of the samples with testosterone <0.7 nM measured by immunoassay were quantified ≥0.7 nM using mass spectrometry. The percentage of serum samples experiencing testosterone breakthrough at >0.7 nM was significantly higher with immunoassay (22.1%) than with mass spectrometry (13.1%; P < 0.0001). Quantitative measurement of serum testosterone levels >0.7 nM by immunoassay can result in an inaccurately identified castration status. Suboptimal testosterone levels in castrated patients should be confirmed by either mass spectrometry or an immunoassay method validated at low testosterone levels and interpreted with caution before any changes are made to treatment management.

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Section: Discussionsupporting

confidence: 79%

Section: Introductionmentioning

confidence: 99%

Discordance between testosterone measurement methods in castrated prostate cancer patients

Rouleau

Lemire

Déry

et al. 2019

Endocrine Connections

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“…The goal of ADT is suppression of testosterone, an androgenic hormone associated with growth and progression of prostate cancer [7]. There is mounting evidence that suppression of patients' testosterone levels below the historical castrate standard of 1.7 nmol/l (e.g., ≤0.7-1.1 nmol/l), is associated with improved treatment outcomes versus patients with higher levels [8][9][10][11][12][13]. Although data support a relationship between lower testosterone levels and clinical benefit, many questions remain on how to translate this knowledge to practice [13].…”

Section: Introductionmentioning

confidence: 99%

“…There is mounting evidence that suppression of patients' testosterone levels below the historical castrate standard of 1.7 nmol/l (e.g., ≤0.7-1.1 nmol/l), is associated with improved treatment outcomes versus patients with higher levels [8][9][10][11][12][13]. Although data support a relationship between lower testosterone levels and clinical benefit, many questions remain on how to translate this knowledge to practice [13]. This Canadian Consensus summarizes evidence and provides guidance developed by a multi-disciplinary panel of experts to assist practicing clinicians in implementing a lower castrate testosterone threshold during ADT for prostate cancer.…”

Section: Introductionmentioning

confidence: 99%

Testosterone suppression in the treatment of recurrent or metastatic prostate cancer — A Canadian consensus statement

Klotz

Shayegan

Guillemette

et al. 2017

CUAJ

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Testosterone suppression, achieved through orchiectomy or medically induced androgen-deprivation therapy (ADT), is a standard treatment for men with recurrent and metastatic prostate cancer. Current assay methods demonstrate the capacity for testosterone suppression to <0.7 nmol/l, and clinical data support improved outcomes from ADT when lower levels are achieved. Practical clinical guidelines are warranted to facilitate adoption of 0.7 nmol/l as the new standard castrate testosterone level.A pan-Canadian group of experts, representing diverse clinical specialties, identified key clinical issues, searched and reviewed relevant literature, and developed consensus statements on testosterone suppression for the treatment of prostate cancer. The expert panel found that current evidence supports the clinical benefit of achieving low testosterone levels during ADT, and encourage adoption of ≤0.7 nmol/l as a new castrate level threshold. The panel recommends regular monitoring of testosterone (e.g., every 3-6 months) and prostate-specific antigen (PSA) levels as clinically appropriate (e.g., every 3-6 months) during ADT, with reassessment of therapeutic strategy if testosterone is not suppressed or if PSA rises regardless of adequate testosterone suppression. The panel also emphasizes the need for greater awareness and education regarding testosterone assay specifications, and strongly promotes the use of mass spectrometry-based assays to ensure accurate measurement of testosterone at castrate levels.

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“…6e9 The European Association of Urology updated its guidelines to recommend a testosterone target below 20 ng/dl during ADT in 2014, 10,11 and the U.S. Food and Drug Administration issued draft guidance in 2019 adding testosterone below 20 ng/dl as a secondary efficacy end point in trials of new gonadotropinreleasing hormone analogues and advised these data be included in labels. 12 Adherence to dosing schedules to maintain T suppression and regular monitoring of prostate specific antigen/T are important to avoid treatment failure, 13 which may lead to decreased survival and increased costs due to greater health care utilization. 14 However, a recent analysis of US clinical data found a high nonadherence rate of 84% for LHRH agonist injections.…”

mentioning

confidence: 99%

Impact of Late Dosing on Testosterone Suppression with 2 Different Leuprolide Acetate Formulations: In Situ Gel and Microsphere. An Analysis of United States Clinical Data

et al. 2021

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Nonadherence to dosing schedules for androgen deprivation therapy increases the risk of testosterone escape for patients with prostate cancer. Two approved formulations of leuprolide acetate, the most commonly prescribed androgen deprivation therapy in the United States, use different extended release delivery technologies: an in situ gel and microspheres. We evaluated the prevalence and impact of late dosing on testosterone suppression for gel and microsphere formulations of leuprolide acetate. Materials and Methods: We retrospectively analyzed records of patients with prostate cancer treated with gel or microsphere delivery of leuprolide acetate. Analyses used 2 definitions of "month," "28-day" (late dosing after day 28, 84, 112 or 168) and "extended" (late dosing after day 32, 97, 128 and 194). Frequencies of late dosing and associated testosterone values were calculated. Results: A total of 2,038 patients received gel and 8,360 received microsphere formulations of leuprolide acetate. More than 80% and 27% of injections were late for 28-day and extended month, respectively. For 28-day month late injections 10% (gel delivery) and 14% (microsphere delivery) of testosterone values were above 50 ng/dl, and 25% (gel) vs 33% (microsphere) were above 20 ng/dl. For extended month 18% (gel) vs 25% (microsphere) were above 50 ng/dl, and 34% (gel) vs 44% (microsphere) were above 20 ng/dl. Microsphere leuprolide acetate was 1.5 times more likely to have testosterone above 50/20 ng/dl vs gel. Least square mean testosterone was 34 ng/dl (gel) vs 46 ng/dl (microsphere) for 28-day month, and 48 ng/dl (gel) vs 76 ng/dl (microsphere) for extended month. Conclusions: Leuprolide acetate therapies were frequently administered late. Gel formulation demonstrated higher rates of testosterone 50 ng/dl or less and 20 ng/dl or less than microsphere formulation. Optimal testosterone suppression can impact prostate cancer progression and patient survival, and differences in extended release technology for androgen deprivation therapy appear relevant.

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

Cited by 9 publications

References 41 publications

Discordance between testosterone measurement methods in castrated prostate cancer patients

Discordance between testosterone measurement methods in castrated prostate cancer patients

Testosterone suppression in the treatment of recurrent or metastatic prostate cancer — A Canadian consensus statement

Impact of Late Dosing on Testosterone Suppression with 2 Different Leuprolide Acetate Formulations: In Situ Gel and Microsphere. An Analysis of United States Clinical Data

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