scholarly journals Acupuncture for the Treatment of Hot Flashes in Men with Advanced Prostate Cancer

2011 ◽  
Vol 02 (01) ◽  
pp. 51-55 ◽  
Author(s):  
Jillian L. Capodice ◽  
Philippa Cheetham ◽  
Mitchell C. Benson ◽  
James M. McKiernan ◽  
Aaron E. Katz
Keyword(s):  
Prostate Cancer ◽  
Advanced Prostate Cancer ◽  
Hot Flashes

A phase II, dose finding, placebo-controlled, study of zuclomiphene citrate to amerliorate the frequency and severity of hot flashes caused by androgen deprivation in men with advanced prostate cancer.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. TPS338-TPS338
Author(s):  
Robert H. Getzenberg ◽  
Domingo Rodriguez ◽  
Michael L Hancock ◽  
Harry Fisch ◽  
Mitchell S. Steiner
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
Advanced Prostate Cancer ◽  
Bone Fractures ◽  
Hot Flashes ◽  
The United States ◽  
Androgen Deprivation ◽  
Dose Finding ◽  
Controlled Study ◽  
Study Results

TPS338 Background: Androgen deprivation therapy (ADT) is the mainstay of treatment for advanced prostate cancer. ADT not only lowers testosterone, but also decreases estrogen levels which can cause significant side effects including hot flashes, loss of bone and bone fractures, and decreases in libido. Up to 80% of the men on ADT report hot flashes and 30-40% of men have moderate to severe hot flashes. Concern over hot flashes make patients less likely to begin ADT and can lead to early discontinuation of ADT. While the off-label use of potent steroidal estrogens has demonstrated efficacy, the appropriate dose as well as dosing route or schedule of these potent estrogens, has not been established. Furthermore, the potential for safety issues with potent steroidal estrogens remains a significant limitation to their clinical utility. Zuclomiphene citrate, is novel weak nonsteroidal estrogenic agent that should ameliorate hot flashes caused by ADT, and as one of the isomers of clomiphene, has a 50 year safety history of being well tolerated in men. Methods: The Phase 2, placebo controlled, dose finding clinical trial (V72203) evaluating zuclomiphene citrate (VERU-944) capsules, oral daily dosing, for the treatment of moderate to severe hot flashes in men with prostate cancer on ADT is in progress. Men are randomized to daily doses of placebo or zuclomiphene 10mg, 50mg or 100mg. V72203 is enrolling approximately 36 men per arm in 10 sites in the United States. The primary efficacy endpoint is the mean change in frequency of moderate and/or severe hot flashes from baseline to week 4 and maintained until week 12. Secondary endpoints include changes from baseline in bone turnover markers, free and total testosterone, SHBG, PSA, and safety. Hot flashes are being measured in real time utilizing an electronic data capture device (ePRO) provided to each subject. We anticipate completion of enrollment by the end of 2018 with study results by second quarter of 2019. Clinical trial information: NCT03646162.

Survey of ADT-induced estrogen deficiency-related side effects in a contemporary cohort of men with advanced prostate cancer.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 235-235
Author(s):  
Robert H. Getzenberg ◽  
Mark C. Scholz ◽  
Alexandra Scholz ◽  
Mitchell S. Steiner
Keyword(s):  
Prostate Cancer ◽  
Side Effects ◽  
Hormonal Therapy ◽  
Advanced Prostate Cancer ◽  
Treatment Options ◽  
Hot Flashes ◽  
Estrogen Deficiency ◽  
Medical Need ◽  
Clinically Significant ◽  
The Impact

235 Background: Androgen Deprivation Therapy (ADT) is a mainstay in the treatment of advanced prostate cancer. ADT-induced estrogen deficiency related side effects may cause men to delay, pause, or discontinue ADT, increases morbidity and mortality, and can significantly impact quality of life. ADT-induced effects include hot flashes, bone loss and fractures, fatigue, decreased libido, and metabolic and lipid changes. Currently there are no FDA approved treatments for ADT-induced hot flashes in men with advanced prostate cancer. In this study, a survey was conducted on the impact of hot flashes, one of the hallmark ADT-induced estrogen deficiency effects, in a contemporary cohort. Methods: During the period of August/September 2019, 212 men with advanced prostate cancer on ADT participated in a digital survey conducted by the Prostate Cancer Research Institute (PCRI) focused on the frequency, severity and impact of their hot flashes. The men were at least 50 years of age with 61% being 70 or older. ADT types included LUPRONÒ(64%), ELIGARDÒ(12%), ZOLADEXÒ(7%) and other forms of hormonal therapy (17%). Results: Of the 212 men surveyed, 99% reported hot flashes with 80% indicating that they experience clinically significant, moderate to severe hot flashes. 77% of men reported that the number of hot flashes stayed the same or increased during their hormonal therapy. 37% of the men experienced more than 5 hot flashes per day and 23% indicated that they felt embarrassed about their hot flashes. Only 51% had either researched how to address their hot flashes or discussed them with their physician. Importantly, 16% considered halting ADT as a result of their hot flashes. Conclusions: This contemporary survey underscores the significant unmet medical need to treat moderate to severe hot flashes which occurred in 80% of the men studied. As about half of the men have not discussed their symptoms with a physician either because of embarrassment or lack of treatment options, the number of men with moderate to severe hot flashes appears to be greatly under-reported. As men on ADT are living longer with prostate cancer, finding an effective and safe treatment for debilitating hot flashes must be a priority.

Rate of hot flashes in patients with advanced prostate cancer treated with GTx-758.

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 129-129
Author(s):  
Evan Y. Yu ◽  
Marc Gittelman ◽  
Thomas E. Keane ◽  
Ronald Tutrone ◽  
Laurence Belkoff ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
Phase Ii ◽  
Advanced Prostate Cancer ◽  
Hot Flashes ◽  
Lower Percentage ◽  
Total Testosterone ◽  
Treatment Groups ◽  
Increased Risk ◽  
Venous Thromboembolic Events

129 Background: When androgen deprivation therapy (ADT) for prostate cancer was first developed, life expectancy for men with advanced disease was short and the systemic effects were of limited relevance. GTx-758 is a selective ERα agonist that effects serum total testosterone (T), free T, SHBG and PSA. Herein we compare the effects of GTx-758 and leuprolide on hot flashes, one of the common side effects in men on ADT. Methods: In a Phase II study (G200705), men with advanced prostate cancer (n=159) received 1000 mg or 2000 mg of GTx-758 daily or leuprolide. Utilizing a standardized instrument to measure the frequency and severity of hot flashes, data was compiled at baseline, day 28 and day 90. The number of men experiencing hot flashes were those reporting any in the period between the respective time point and the prior patient visit. All p values describe the comparison of both GTx-758 treatment groups to the leuprolide treated men. Results: At the baseline, there were no significant differences in the number of men reporting hot flashes in any of the treatment groups (p=0.065). The percentage of men who experienced a hot flash while receiving leuprolide increased significantly to 60.4% (p<0.0001) by Day 28 and increased further to 80.9% (p<0.0001) by Day 90. Although some subjects experienced hot flashes while receiving GTx-758, these men were a significantly lower percentage, 18.8 and 5.6% at the 1000 mg and 2000 mg doses of GTx-758 respectively at day 90. As a result of an increased risk of venous thromboembolic events (VTEs) at these higher doses of GTx-758, the trial was stopped prior to its completion and not all of the men on the study reached the 90 day treatment date (99 evaluable). Conclusions: Men with advanced prostate cancer, receiving GTx-758 experienced a greater than 4-fold reduction in their reported hot flashes at day 90. Since hot flashes are a major side effect that impacts the quality of life in men on ADT, the ability to significantly decrease their likelihood would seem to be of great benefit. A Phase II clinical trial utilizing lower doses of GTx-758 (G200712) is currently being performed that will determine if similar effects on serum free testosterone, PSA and hot flashes can be shown with a lower rate of VTEs. Clinical trial information: NCT01326312.

scholarly journals Preclinical Characterization of a Novel Diphenyl Benzamide Selective ERα Agonist for Hormone Therapy in Prostate Cancer

Endocrinology ◽  
2012 ◽  
Vol 153 (3) ◽  
pp. 1070-1081 ◽  
Author(s):  
Christopher C. Coss ◽  
Amanda Jones ◽  
Deanna N. Parke ◽  
Ramesh Narayanan ◽  
Christina M. Barrett ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Side Effects ◽  
Androgen Deprivation Therapy ◽  
Advanced Prostate Cancer ◽  
Hot Flashes ◽  
Specific Antigen ◽  
Disease Free Survival ◽  
Estrogen Deficiency ◽  
Androgen Deprivation ◽  
Term Therapy

Androgen deprivation therapy (ADT) is the mainstay of treatment for advanced prostate cancer. ADT improves overall and disease-free survival rates, but long-term therapy is associated with severe side effects of androgen and estrogen depletion including hot flashes, weight gain, depression, and osteoporosis. Effective hormone reduction can be achieved without estrogen deficiency-related side effects by using therapy with estrogenic compounds. However, cardiovascular complications induced by estrogens coupled with the availability of LHRH agonists led to discontinuation of estrogen use for primary androgen deprivation therapy in the 1980s. New treatments for prostate cancer that improve patient outcomes without the serious estrogen deficiency-related toxicities associated with ADT using LHRH analogs are needed. Herein we describe a novel nonsteroidal selective estrogen receptor-α agonist designed for first-line therapy of advanced prostate cancer that in animal models induces medical castration and minimizes many of the estrogen deficiency-related side effects of ADT. The present studies show that orally administered GTx-758 reversibly suppressed testosterone to castrate levels and subsequently reduced prostate volume and circulating prostate-specific antigen in relevant preclinical models without inducing hot flashes, bone loss, thrombophilia, hypercoagulation, or increasing fat mass.

scholarly journals A successful treatment using gabapentin against hot flashes due to LH-RH agonist in a patient with advanced prostate cancer

2009 ◽  
Vol 4 (2) ◽  
pp. 334-338
Author(s):  
Hiroto Araki ◽  
Kousuke Yamanaka ◽  
Takashi Sakai ◽  
Meiko Matsuura ◽  
Misuzu Okai ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Successful Treatment ◽  
Advanced Prostate Cancer ◽  
Hot Flashes ◽  
Lh Rh
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