Bone mineral density changes on androgen deprivation therapy for prostate cancer and response to antiresorptive therapy

Yaturu, Subhashini; Djedjos, Stephen; Alferos, G; Deprisco, C

doi:10.1038/sj.pcan.4500846

Cited by 15 publications

(8 citation statements)

References 25 publications

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“…Previous studies have shown that use of androgen‐deprivation therapy, such as leuprorelin acetate and goserelin acetate, decreases bone density . This is expected as gonadal hormones are essential for maintaining bone health.…”

Section: Discussionmentioning

confidence: 99%

Phase I trial of TAK‐385 in hormone treatment‐naïve Japanese patients with nonmetastatic prostate cancer

et al. 2019

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This open‐label, phase I dose‐finding study evaluated the gonadotropin‐releasing hormone antagonist, TAK‐385, in Japanese patients with nonmetastatic prostate cancer. In a two‐part design, patients received daily oral TAK‐385 at doses of 320 (loading, day 1)/80 (maintenance, day 2 and thereafter), 320/120, 320/160, or 360/120 mg for 28 days in a dose‐escalation phase (part A, n = 13), and at 320/80 or 320/120 mg for up to 96 weeks in a randomized expansion phase (part B, n = 30). Primary endpoint in both parts was safety, including dose‐limiting toxicity in part A. Secondary endpoints included pharmacokinetics, pharmacodynamics, and prostate‐specific antigen concentration. Ten (77%) patients in part A and all patients in part B experienced an adverse event; hot flush (part A, n = 4; part B, n = 15), viral upper respiratory tract infection (part A, n = 1; part B, n = 10), and diarrhea (part B, n = 8) were most frequent. No dose‐limiting toxicities were observed (part A). In 12 evaluable patients (part A), TAK‐385 was rapidly absorbed after a single loading dose; on day 28 (maintenance dose), median steady‐state Tmax was ~1‐2 hours and mean t1/2z was 67‐79 hours. All doses rapidly reduced testosterone concentrations to castration levels within 1 week. Durable reductions in prostate‐specific antigen of >90% from baseline were observed through 96 weeks. TAK‐385 appeared tolerable and resulted in sustained reductions in testosterone to castration levels at all doses. The lowest loading/maintenance dose required for a clinical effect was 320/80 mg. http://ClinicalTrials.gov: NCT02141659.

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Section: Discussionmentioning

confidence: 99%

Phase I trial of TAK‐385 in hormone treatment‐naïve Japanese patients with nonmetastatic prostate cancer

et al. 2019

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“…Loss of bone mineral density is a well-known consequence of androgen deprivation therapy in men with prostate cancer [23, 24]. Review of the results of 12 clinical trials was said to have shown that, at the doses commonly recommended, 500–1,000 mg calcium and 200–500 IU vitamin D per day, men undergoing androgen deprivation lose bone mineral density [23].…”

Section: Discussionmentioning

confidence: 99%

Vitamin D Levels in Subjects with Prostate Cancer Compared to Age-Matched Controls

2012

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Prostate cancer (PCa) is the second most common cancer in men worldwide and the second leading cause of cancer deaths in men in the United States. Vitamin D is considered to have anticancer properties, currently thought to work mainly through its nuclear receptor or vitamin D receptor. In this retrospective study, we compared vitamin D levels in subjects with PCa with those of age-matched men without PCa. Study subjects included 479 in each group with a mean age of 73 and a mean creatinine of 1.05 and 1.15. Levels of 25 (OH) vitamin D were 28.4 ± 0.54 and 28.05 ± 0.62 in subjects with and without PCa. Levels of 1,25 (OH) vitamin D were 47.2 ± 6.8 and 47.1 ± 7.11 in subjects with and without PCa. In contrast to other studies, we did not find a significant difference in vitamin D levels. Among prostate cancer patients, vitamin D levels correlated positively with age (r = 0.12, P < 0.02), and were negatively associated with BMI (r = −0.13, P = 0.003), glucose (r = −0.12, P < 0.007), HbA1C (r = −0.16, P = 0.001), and PTH (r = −0.21; P < 0.0001). The data do not show the causal effect of vitamin D levels on PCa.

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“…However, there are a number of side effects of ADT that negatively impact the health-related quality of life in these men. The side effects of such treatment include osteoporosis, [4,5] increased fracture risk, [6-8] poorer quality of life with decline in physical function, [9,10] fatigue, decline in muscle mass, increased fat mass, weight gain, [11,12] reduced psychosocial and cognitive functions [13,14]. Osteoporosis and physical function decline are of particular concern as these are factors that are closely related to risks of falls and fractures in older men [15-18].…”

Section: Introductionmentioning

confidence: 99%

A pilot study of exercise in men with prostate cancer receiving androgen deprivation therapy

2012

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BackgroundAndrogen deprivation therapy (ADT) is the mainstay therapy for men with prostate cancer. However, there are musculoskeletal side effects from ADT that increase the risk for osteoporosis and fracture, and can compromise the quality of life of these individuals. The objectives of this study are to determine the efficacy of a home-based walking exercise program in promoting bone health, physical function and quality of life in men with prostate cancer receiving ADT.Methods/DesignA 12-month prospective, single-blinded, randomized controlled trial will be conducted to compare the Exercise Group with the Control Group. Sixty men with prostate cancer who will be starting ADT will be recruited and randomly assigned to one of the two groups: the Exercise Group will receive instructions in setting up an individualized 12-month home-based walking exercise program, while the Control Group will receive standard medical advice from the attending physician. A number of outcome measures will be used to assess bone health, physical function, and health-related quality of life. At baseline and 12 months, bone health will be assessed using dual-energy X-ray absorptiometry. At baseline and every 3 months up to 12 months, physical function will be evaluated using the Functional Assessment of Chronic Illness Therapy - Fatigue Scale, Activities-specific Balance Confidence Scale, Short Physical Performance Battery, and Six-Minute Walk Test; and health-related quality of life will be assessed using the Functional Assessment of Cancer Therapy Prostate Module and the Medical Outcomes Study 12-item Short Form Health Survey Version 2. A mixed multiple analysis of variance will be used to analyze the data.DiscussionMusculoskeletal health management remains a challenge in men with prostate cancer receiving ADT. This study addresses this issue by designing a simple and accessible home-based walking exercise program that will potentially have significant impact on reducing the risk of fracture, promoting physical function, and ultimately improving the health-related quality of life in men with prostate cancer receiving ADT.Trial registrationClinicalTrials.gov: NCT00834392.

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Bone mineral density changes on androgen deprivation therapy for prostate cancer and response to antiresorptive therapy

Cited by 15 publications

References 25 publications

Phase I trial of TAK‐385 in hormone treatment‐naïve Japanese patients with nonmetastatic prostate cancer

Phase I trial of TAK‐385 in hormone treatment‐naïve Japanese patients with nonmetastatic prostate cancer

Vitamin D Levels in Subjects with Prostate Cancer Compared to Age-Matched Controls

A pilot study of exercise in men with prostate cancer receiving androgen deprivation therapy

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