Clinical trial NCT04252625: Trial of Quercetin, Bromelain, Rye Flower Pollen & Papain on Reducing Severity of Radiation-Induced Prostatitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Adenocarcinoma
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Farr Labs, LLC
First posted: 2020-02-05
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An asymmetric two-sided group sequential design will be used with an interim analysis for efficacy and futility.
Primary purpose: TREATMENT

Brief summary: This study will assess the difference in prostatitis symptoms in men with localized prostate cancer following brachytherapy taking Q-Urol relative to placebo.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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 ≤ 1.
* Adequate organ function as defined as:

  * Hepatic:

    * Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)
    * aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 × institutional ULN
  * Renal:

    * 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.

Exclusion Criteria:

* Baseline AUA symptom scores \> 15.
* 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
  * Diabetes
  * 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.

Primary outcomes:
measure: National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI)
timeFrame: up to 6 weeks after the start of study treatment
Secondary outcomes:
measure: The Expanded Prostate Cancer Index Composite (EPIC) Assessment
timeFrame: up to 6 weeks after the start of study treatment
measure: The International Prostate Symptom Score (I-PSS) Assessment
timeFrame: up to 6 weeks after the start of study treatment
measure: The Rectal Function Assessment Score (R-FAS) Assessment
timeFrame: At the End of Treatment Visit, up to 8 weeks after initiation of study treatment.
measure: Sexual Health Inventory for Men (SHIM) Assessment
timeFrame: At the End of Treatment Visit, up to 8 weeks after initiation of study treatment.
measure: Impact on Serum Biomarkers of Inflammation - Erythrocyte Sedimentation Rate (ESR)
timeFrame: At the End of Treatment Visit, up to 8 weeks after initiation of study treatment.
measure: Impact on Serum Biomarkers of Inflammation - C-reactive Protein
timeFrame: At the End of Treatment Visit, up to 8 weeks after initiation of study treatment.
measure: Impact on Serum Biomarkers of Inflammation - Prostate-specific Antigen (PSA)
timeFrame: At the End of Treatment Visit, up to 8 weeks after initiation of study treatment.
measure: Adverse Events by Grade
timeFrame: up to 10.5 weeks after initiation of study treatment
measure: Days of Pain Medication
timeFrame: up to 28 days after initiation of study treatment
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute at University of Utah
state: Utah
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
Study officials:
affiliation: Huntsman Cancer Institute/ University of Utah
name: Jonathan Tward, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: