A Randomized Phase 2 Trial of White Button Mushroom Supplement in Patients With Biochemically Recurrent Prostate Cancer Following Local Therapy and in Therapy Na?ve Patients With Favorable Risk Prostate Cancer Undergoing Active Surveillance
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 133
- 试验地点
- 13
- 主要终点
- Prostate-specific antigen (PSA) (ng/mL) levels (Cohort 1)
研究概览
简要总结
This phase II trial studies how well white button mushroom supplement works in reducing prostate-specific antigen (PSA) levels in patients with prostate cancer that has come back (recurrent) or has favorable risk and has not undergone any therapy (therapy naive). PSA is a blood marker of prostate growth. White button mushroom supplement may affect PSA level, various parameters of immune system and levels of hormones that may have a role in prostate cancer growth.
详细描述
PRIMARY OBJECTIVES:
I. To assess the proportion of patients with any prostate specific antigen (PSA) reduction at 12 weeks (~3 months) in observation + white button mushroom (WBM) supplement arm and observation only arm (control arm). (Cohort 1) II. To assess relative change in PSA at 48 weeks (~12 months) from baseline with or without WBM treatment. (Cohort 2)
SECONDARY OBJECTIVES:
I. To evaluate, adverse events, PSA-response rate and time to PSA progression. (Cohort 1) II. To evaluate adverse events, time to initiation of additional therapy and progression. (Cohort 2)
EXPLORATORY OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Documented informed consent of the participant and/or legally authorized representative
- •For therapy naive favorable risk prostate cancer (cohort 2 only): agreement to undergo baseline and 48 week prostate biopsy
- •Willing to forego non-study supplements containing mushroom for the duration of the study
- •Eastern Cooperative Oncology Group (ECOG) =< 2
- •Histologically or cytologically confirmed history of adenocarcinoma of the prostate
- •BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: PSA failure defined as:
- •PSA of >= 0.2 ng/mL that has increased above nadir following prostatectomy, OR
- •PSA increase of 2.0 ng/mL above post-therapy nadir if other primary local therapy was used instead of prostatectomy
- •NOTE: PSA value must be increasing based on 2 consecutive measurements taken at least 2 weeks apart
- •BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: Testosterone levels > 50 ng/dL
- •BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: Received any number of primary local therapies, defined as:
- •Radical prostatectomy
- •External beam radiation therapy
- •Radioactive seed implantation
- •Cryotherapy
- •High-intensity focused ultrasound (HIFU)
- •BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: May have received up to 24 months of neoadjuvant/adjuvant androgen deprivation therapy in conjunction with primary local therapy. Androgen deprivation therapy must have been completed > 6 months from day (D)1 of the study
- •BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: Neoadjuvant/adjuvant cytotoxic chemotherapy must have been completed > 6 months from day (D)1 of the study
- •BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: No clinical or radiographic evidence of metastatic disease within 2 months prior to day 1 of protocol therapy. If metastatic disease is detected by positron emission tomography (PET) imaging only patients are eligible as long as no metastatic disease is noted on computed tomography (CT) scan (or magnetic resonance imaging [MRI]) and bone scan
- •THERAPY NAIVE FAVORABLE RISK PROSTATE CANCER COHORT (COHORT 2) ONLY: Adenocarcinoma of the prostate diagnosed =< 12 months of protocol screening and has elected active surveillance as preferred management plan OR already on active surveillance
- •THERAPY NAIVE FAVORABLE RISK PROSTATE CANCER COHORT (COHORT 2) ONLY: Clinical stage T1c-T2a as defined below:
- •T1c: Tumor identified by needle biopsy found in one or both sides, but not palpable
- •T2a: Tumor involves one-half of one side or less
- •THERAPY NAIVE FAVORABLE RISK PROSTATE CANCER COHORT (COHORT 2) ONLY: Gleason score =< 6 (grade group 1) or Gleason 3+4 (grade group 2)
- •THERAPY NAIVE FAVORABLE RISK PROSTATE CANCER COHORT (COHORT 2) ONLY: Adequate biopsy of at least 10 biopsy cores
- •THERAPY NAIVE FAVORABLE RISK PROSTATE CANCER COHORT (COHORT 2) ONLY: No prior therapy for prostate cancer defined as:
- •Local therapy including surgery , radiation or focal therapy (cryoablation, HIFU, light)
- •Systemic therapy (hormonal, immunotherapy, targeted, chemotherapy). Subjects who have used 5-alpha reductase inhibitor (e.g. finasteride or dutasteride) > 6 months prior to D1 of protocol therapy will be allowed
- •Platelets > 100,000 /mm^3 (within 28 days prior to day 1 of protocol therapy)
- •Hemoglobin > 8 g/dL (within 28 days prior to day 1 of protocol therapy)
- •Aspartate aminotransferase, alanine aminotransferase, < 3 x upper limit of normal (ULN) (within 28 days prior to day 1 of protocol therapy)
- •Total bilirubin < 2 x ULN (within 28 days prior to day 1 of protocol therapy)
- •Creatinine < 2 x ULN (within 28 days prior to day 1 of protocol therapy)
排除标准
- •Other concomitant investigational anti-cancer therapy/ vaccines/biologics, corticosteroids with > 10 mg of prednisone equivalent dose
- •Therapy with mushroom supplements within last 3 months of randomization
- •BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: Neoadjuvant/adjuvant androgen derivation therapy lasting > 24 months or within 6 months prior to day 1 of protocol therapy
- •BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: Neoadjuvant/adjuvant chemotherapy within 6 months prior to day 1 of protocol therapy
- •BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: Prior therapy for recurrent prostate cancer (unless given as a component of attempted curative salvage treatment including salvage radiation therapy, and completed > 6 months before day 1 of protocol therapy):
- •Chemotherapy
- •Androgen deprivation therapy
- •Immunotherapy
- •Targeted therapy
- •Known history of allergic reaction to mushrooms
- •Clinically significant uncontrolled illness
- •Active infection requiring treatment
- •Uncontrolled congestive heart failure, cardiac arrhythmia
- •History of other primary non-skin malignancy within previous 2 years unless treated with curative intent and in remission
- •Any other condition that would, in the Investigator?s judgment, contraindicate the patient?s participation in the clinical study due to safety concerns with clinical study procedures
- •Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
研究组 & 干预措施
Arm IB (clinical observation)
Patients undergo clinical observation for 12 weeks. If PSA continues to increase, patients have the option to receive the white button mushroom extract as in arm IA.
干预措施: Clinical Observation (Other)
Arm IB (clinical observation)
Patients undergo clinical observation for 12 weeks. If PSA continues to increase, patients have the option to receive the white button mushroom extract as in arm IA.
干预措施: Questionnaire Administration (Other)
Arm IIB (active surveillance)
Patients undergo active surveillance for 48 weeks.
干预措施: Questionnaire Administration (Other)
Arm IA (white mushroom extract)
Patients receive white button mushroom extract PO BID on day 1. Treatment repeats every 4 weeks for cycles 1-3 then every 12 weeks for cycles 4-6 (36 weeks) in the absence of disease progression or unacceptable toxicity.
干预措施: White Button Mushroom Extract (Drug)
Arm IIA (white mushroom extract)
Patients receive white mushroom extract PO BID on day 1. Treatment repeats every 12 weeks for 4 cycles (48 weeks) in the absence of disease progression or unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
Arm IIA (white mushroom extract)
Patients receive white mushroom extract PO BID on day 1. Treatment repeats every 12 weeks for 4 cycles (48 weeks) in the absence of disease progression or unacceptable toxicity.
干预措施: White Button Mushroom Extract (Drug)
Arm IIB (active surveillance)
Patients undergo active surveillance for 48 weeks.
干预措施: Patient Observation (Other)
Arm IA (white mushroom extract)
Patients receive white button mushroom extract PO BID on day 1. Treatment repeats every 4 weeks for cycles 1-3 then every 12 weeks for cycles 4-6 (36 weeks) in the absence of disease progression or unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Prostate-specific antigen (PSA) (ng/mL) levels (Cohort 1)
时间窗: At 12 weeks
For continuous variables, descriptive statistics (number \[n\], mean, standard deviation, standard error, median range) will be provided. For categorical variables, patient counts and percentages will be provided.
Relative change in PSA (Cohort 2)
时间窗: Baseline up to 48 weeks
The relative difference in PSA will be measured as log (48 week PSA/baseline PSA). Undetectable PSA at 48 weeks will be coded as the low end of the lab measurement range for PSA. This measure of relative difference will be compared between the white button supplement (WBM) + active surveillance and active surveillance only patients. For continuous variables, descriptive statistics (n, mean, standard deviation, standard error, median range) will be provided. For categorical variables, patient counts and percentages will be provided.
次要结局
- Incidence of adverse events(Up to 48 weeks)
- Proportion of patients with PSA response (Cohort 1)(Up to 48 weeks)
- Time to PSA progression (Cohort 1)(Time from randomization to PSA progression, assessed up to 48 weeks)
- Time to initiation of additional therapy (Cohort 2)(Baseline up to 48 weeks)
- Time to progression (Cohort 2)(From randomization to progression, assessed up to 48 weeks)