A Randomized Phase II Trial of Flibanserin in Men Receiving Androgen Suppression for Prostate Cancer

氟班色林在接受雄激素抑制治疗前列腺癌的男性中的随机 II 期试验

• 批准号: 10195766
• 负责人: Andrew M McDonald
• 金额: $ 20.83万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-19 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10195766
• 关键词: Adverse effects; Adverse event; Aggressive behavior; Agonist; Alabama; Androgen Suppression; Androgens; Behavior; Behavioral; Biochemical; Brain; Brain region; Cancer Intervention; Cancer Survivorship; Castration; Client satisfaction; Clinical; Clinical Trials; Coitus; Comprehensive Cancer Center; Diagnosis; Disadvantaged; Distress; Dopamine; Dopamine Agonists; Dopamine D2 Receptor; Double-Blind Method; Drug Interactions; Equilibrium; Erectile dysfunction; Ergot Fungus; Estrogens; Evidence based treatment; Exercise; Female; Frequencies; Goals; Gynecomastia; Human; Hyperprolactinemia; Hypoactive Sexual Desire Disorder; Intervention; Life; Life Style; Localized Disease; Malignant neoplasm of prostate; Morbidity - disease rate; Neurotransmitters; Participant; Patients; Pharmaceutical Preparations; Phase I Clinical Trials; Phase II Clinical Trials; Phase II/III Trial; Phase III Clinical Trials; Placebos; Premenopause; Prostate Cancer therapy; Psychoses; Quality of life; Radiation; Randomized; Rattus; Reporting; Research; Research Personnel; Risk; Safety; Serotonin; Serotonin Agonists; Sex Behavior; Sex Functioning; Sexual Dysfunction; Sexual Health; Site; Specific qualifier value; Spouses; Structure; Synapses; Testosterone; Thromboembolism; Time; Toxic effect; United States; Universities; Well in self; Woman; androgen deprivation therapy; arm; cabergoline; cardiovascular effects; design; experience; flibanserin; high risk; improved; inhibitor/antagonist; interest; male; men; multidisciplinary; negative affect; neurochemistry; phase II trial; phosphodiesterase V; placebo group; preclinical study; preservation; prostate cancer survivors; psychologic; receptor; recruit; sex; success; treatment strategy; Adverse effects; Adverse event; Aggressive behavior; Agonist; Alabama; Androgen Suppression; Androgens; Behavior; Behavioral; Biochemical; Brain; Brain region; Cancer Intervention; Cancer Survivorship; Castration; Client satisfaction; Clinical; Clinical Trials; Coitus; Comprehensive Cancer Center; Diagnosis; Disadvantaged; Distress; Dopamine; Dopamine Agonists; Dopamine D2 Receptor; Double-Blind Method; Drug Interactions; Equilibrium; Erectile dysfunction; Ergot Fungus; Estrogens; Evidence based treatment; Exercise; Female; Frequencies; Goals; Gynecomastia; Human; Hyperprolactinemia; Hypoactive Sexual Desire Disorder; Intervention; Life; Life Style; Localized Disease; Malignant neoplasm of prostate; Morbidity - disease rate; Neurotransmitters; Participant; Patients; Pharmaceutical Preparations; Phase I Clinical Trials; Phase II Clinical Trials; Phase II/III Trial; Phase III Clinical Trials; Placebos; Premenopause; Prostate Cancer therapy; Psychoses; Quality of life; Radiation; Randomized; Rattus; Reporting; Research; Research Personnel; Risk; Safety; Serotonin; Serotonin Agonists; Sex Behavior; Sex Functioning; Sexual Dysfunction; Sexual Health; Site; Specific qualifier value; Spouses; Structure; Synapses; Testosterone; Thromboembolism; Time; Toxic effect; United States; Universities; Well in self; Woman; androgen deprivation therapy; arm; cabergoline; cardiovascular effects; design; experience; flibanserin; high risk; improved; inhibitor/antagonist; interest; male; men; multidisciplinary; negative affect; neurochemistry; phase II trial; phosphodiesterase V; placebo group; preclinical study; preservation; prostate cancer survivors; psychologic; receptor; recruit; sex; success; treatment strategy

PROJECT SUMMARY Androgen deprivation therapy (ADT) is used to improve survival for men with metastatic and high risk localized prostate cancer. Unfortunately, ADT is also associated with a number of adverse effects, and sexual dysfunction occurs in nearly all men who receive this treatment. Sexual dysfunction is the most common complaint among men with prostate cancer and contributes to worse quality of life (QoL). The loss of sexual interest, in particular, is highly distressing for men with prostate cancer and their partners, which contributes additional psychological morbidity in these patients. Despite the importance of sexual health in men with prostate cancer, previous interventions to improve sexual interest in men receiving ADT have had little success, and new strategies are needed. We hypothesize that flibanserin can be used to increase sexual desire among men receiving ADT for prostate cancer. Flibanserin is a multifunctional serotonin receptor agonist/antagonist that acts as an agonist of post-synaptic 5-HT(1A) receptors and an antagonist of 5-HT(2A) receptors, that has previously been approved to treat hypoactive sexual desire disorder in women. In this proposal, we will conduct a double blind, placebo controlled, randomized phase II clinical trial to assess the efficacy and safety of flibanserin 100mg daily among men receiving ADT for prostate cancer. We will recruit 50 men with prostate cancer who are receiving ADT and also endorse reduced sexual interest to participate. Men will be randomized to receive either daily flibanserin 100mg or placebo for a 12-week period. Patient-reported frequency of attempted sexual intercourse, sexual QoL, global QoL, and toxicity will be assessed at baseline and at pre-specified time points. Specific Aim 1 will assess the efficacy of flibanserin. The frequency of attempted sexual intercourse among men receiving flibanserin will be compared to men receiving placebo. The change in patient reported sexual QoL will also be compared between the study groups. Specific Aim 2 will assess the safety and tolerance of flibanserin. The frequency of grade 3+ adverse events and study drug discontinuation among men receiving flibanserin will be reported. The frequency of grade 2+ and grade 3+ patient reported adverse events will be compared between the flibanserin and placebo groups. Accomplishing these specific aims will provide us with a preliminary understanding about use of flibanserin in men receiving ADT for prostate cancer. This study will be conducted by a qualified multidisciplinary team of investigators with experience in both clinical trials and cancer survivorship research at the University of Alabama at Birmingham O’Neal Comprehensive Cancer Center. The results of this clinical trial will be used to inform the design of a phase III clinical trial. Our long-term goal is to develop an evidence based treatment strategy that will significantly improve sexual health and QoL for prostate cancer survivors.

项目摘要 雄激素剥夺疗法（ADT）用于改善转移和高风险男性的生存率 局部前列腺癌。不幸的是，ADT也与许多不利影响和性有关 功能障碍发生在几乎所有接受这种治疗的男性中。性功能障碍是最常见的 前列腺癌男性的抱怨并导致生活质量较差（QOL）。失去性 尤其是对前列腺癌及其伴侣的男性的兴趣非常令人痛苦，这有助于 这些患者的额外心理发病率。尽管有性健康在前列腺男性中很重要 癌症，以前提高接受ADT男性性兴趣的干预措施几乎没有成功，而新的 需要策略。我们假设flibanserin可用于增加男性的性欲 接受前列腺癌的ADT。 Flibanserin是一种多功能的5-羟色胺接收器激动剂/拮抗剂，可起作用 作为后突触后5-HT（1A）受体和5-HT（2A）受体的拮抗剂的激动剂，以前具有 他被批准治疗女性的性欲障碍。在此提案中，我们将进行双重 盲，安慰剂对照，随机II期临床试验，以评估氟班塞林100mg的有效性和安全性 每天在接受ADT治疗前列腺癌的男性中。我们将招募50名患有前列腺癌的男性 接受ADT并认可减少性利益参加。男人将被随机接收 每日氟班塞林100mg或安慰剂长达12周。试图性的患者报告的频率 在基线和预先指定的时间点，将评估性交，性QOL，全球QOL和毒性。 具体目标1将评估氟班塞林的效率。尝试性交的频率 接受Flibanserin的男性将与接受安慰剂的男人进行比较。患者的变化报告了性QOL 还将在研究组之间进行比较。特定目标2将评估 flibanserin。 3级以上的不良事件的频率和研究中停用的药物的频率 Flibanserin将被报告。 2+级和3级以上患者报告的不良事件的频率将是 比较flibanserin和安慰剂组。完成这些具体目标将为我们提供 关于在接受ADT治疗前列腺癌的男性中使用flibanserin的初步了解。这项研究将是 由合格的多学科研究人员进行的，具有临床试验和癌症经验的经验 伯明翰O'Neal综合癌症中心的阿拉巴马大学生存研究。这 该临床试验的结果将用于告知III期临床试验的设计。我们的长期目标是 制定基于证据的治疗策略，该策略将显着改善前列腺的性健康和质量 癌症幸存者。