A Phase II Randomized Controlled Trial of a Supplement Containing Quercetin, Bromelain, Rye Flower Pollen, and Papain on Reducing the Severity of Radiation-Induced Prostatitis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI)
研究概览
简要总结
This study will assess the difference in prostatitis symptoms in men with localized prostate cancer following brachytherapy taking Q-Urol relative to placebo.
详细描述
This is a Phase 2, double-blinded, placebo-controlled trial assessing the safety of Q-Urol use after brachytherapy placement in patients with localized prostate cancer. Patients will be randomized in a 1:1 ratio to receive Q-Urol/Placebo twice daily for 6 weeks after brachytherapy placement. Questionnaires will be administered pre- and post-treatment to assess the change in prostatitis symptoms and quality of life measures. The mean values between groups will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double-blinded, placebo-controlled
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subjects aged ≥ 18 years.
- •Men with histologically proven localized prostate adenocarcinoma, stage I - III (as defined by American Joint Committee on Cancer (AJCC) 8th edition), who have selected treatment with brachytherapy with or without external beam radiation, with or without androgen deprivation therapy.
- •Fluent in speaking and reading English.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status ≤
- •Adequate organ function as defined as:
- •Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)
- •aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 × institutional ULN
- •Estimated creatinine clearance ≥ 30 mL/min by Cockcroft-Gault formula:
- •Males: ((140-age)×weight[kg])/(serum creatinine [mg/dL]×72)
- •Highly effective contraception for both male and their female partners of childbearing potential throughout the study and for at least 5 days after last study treatment administration if the risk of conception exists.
- •Median life expectancy ≥ 5 years as calculated by the Lee and Schonberg Index (https://eprognosis.ucsf.edu/leeschonberg.php)
- •Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
排除标准
- •Baseline AUA symptom scores >
- •Prior diagnosis of chronic prostatitis type II through IV.
- •Subject has received systemic therapy intended for the treatment of prostatitis (including herbal supplements) ≤ 14 days of starting study treatment.
- •Subject has received a fluoroquinolone antibiotic (e.g. ciprofloxacin, norfloxacin, ofloxacin levofloxacin, etc.) ≤ 3 days of starting study treatment.
- •Subject is actively on anti-inflammatory medications for other medical conditions, unless approved by PI.
- •Subject has undergone transurethral resection of the prostate (TURP).
- •Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
- •History of irritable bowel syndrome, chronic fatigue syndrome, fibromyalgia, and interstitial cystitis-bladder pain syndrome (IC/BPS).
- •History of symptomatic hypotension, falls, or syncope
- •History of hypoglycemia.
- •Actively abusing alcohol or drugs
- •Subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
- •Congestive heart failure
- •Pulmonary artery hypertension
- •Any clinically significant condition that requires therapy with diuretic medications for any indication other than the management of hypertension.
- •Other clinically significant disorders that would, in the opinion of the treating investigator, preclude safe study participation.
- •Known prior severe hypersensitivity to investigational product or any component in its formulations (NCI CTCAE v5.0 Grade ≥ 3).
- •Known allergy to pineapple or pineapple containing products.
- •Subjects taking prohibited medications as described in Section 7.3 A washout period of prohibited medications for a period of at least 5 half-lives or as clinically indicated should occur prior to the start of treatment.
研究组 & 干预措施
Arm 1: Q-Urol
Patients will be randomized in a 1:1 ratio to receive Q-Urol, two capsules, twice daily for 6 weeks after brachytherapy placement.
Questionnaires will be administered pre- and post-treatment to assess the change in prostatitis symptoms and quality of life measures. The mean values between groups will be compared.
干预措施: Q-Urol (Drug)
Arm 2: Placebo
Patients will be randomized in a 1:1 ratio to receive Placebo, two capsules, twice daily for 6 weeks after brachytherapy placement.
Questionnaires will be administered pre- and post-treatment to assess the change in prostatitis symptoms and quality of life measures. The mean values between groups will be compared.
干预措施: Placebo (Drug)
结局指标
主要结局
National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI)
时间窗: up to 6 weeks after the start of study treatment
This outcome will report the mean score of the NIH-CPSI, a 13-item questionnaire. This questionnaire will report 4 sub-scores, Pain, Urinary Symptoms, Quality of Life (QOL) Impact, and Pain + Urinary score, and the total score. Pain: The sum of 6 items (0 No-1 Yes), one scale (0 Never-5 Always), and one scale (0 No Pain-10 Pain as bad as you can imagine); Range: 0-21, higher values indicating worse outcomes. Urinary Symptoms: The sum of 2 urine items (0 Not at all-5 Almost always); Range: 0-10, higher values indicating worse outcomes. QOL Impact: The sum of 2 items (0 None-3 A lot) and 1 scale (0 Delighted-6 Terrible); Range: 0-12, higher values indicating worse outcomes. Pain and Urinary sub-score: The sum of the Pan and Urinary Symptoms scores; Range: 0-31, higher values indicating worse outcomes. Total Score: The sum of all questions; Range: 0-43, higher values indicating worse outcomes. This outcome measure is assessed at 6 weeks after the start of study treatment.
次要结局
- The Expanded Prostate Cancer Index Composite (EPIC) Assessment(up to 6 weeks after the start of study treatment)
- The International Prostate Symptom Score (I-PSS) Assessment(up to 6 weeks after the start of study treatment)
- The Rectal Function Assessment Score (R-FAS) Assessment(At the End of Treatment Visit, up to 8 weeks after initiation of study treatment.)
- Sexual Health Inventory for Men (SHIM) Assessment(At the End of Treatment Visit, up to 8 weeks after initiation of study treatment.)
- Impact on Serum Biomarkers of Inflammation - Erythrocyte Sedimentation Rate (ESR)(At the End of Treatment Visit, up to 8 weeks after initiation of study treatment.)
- Impact on Serum Biomarkers of Inflammation - C-reactive Protein(At the End of Treatment Visit, up to 8 weeks after initiation of study treatment.)
- Impact on Serum Biomarkers of Inflammation - Prostate-specific Antigen (PSA)(At the End of Treatment Visit, up to 8 weeks after initiation of study treatment.)
- Adverse Events by Grade(up to 10.5 weeks after initiation of study treatment)
- Days of Pain Medication(up to 28 days after initiation of study treatment)