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Trial of Supplement of Quercetin, Bromelain & Papain on Reducing Severity of Radiation-Induced Prostatitis (PROSTA-Q)

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ClinicalTrials.gov Identifier: NCT04252625
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
University of Utah

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

Condition or disease Intervention/treatment Phase
Prostate Adenocarcinoma Drug: Prosta-Q Drug: Placebo Phase 2

Detailed Description:

This is a Phase 2, double-blinded, placebo-controlled trial assessing the safety of Prosta-Q use after brachytherapy placement in patients with localized prostate cancer. Patients will be randomized in a 1:1 ratio to receive Prosta-Q/Placebo twice daily for 4-6 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.

An interim analysis will be conducted for futility and efficacy after 42 patients have been enrolled (21 to each arm) and reviewed by the DSMC. If the analysis is favorable, as defined in the Statistical Analysis section, the trial will open to the enrollment of 98 additional subjects, 49 per arm. However, if the analysis does not demonstrate standards defined in the statistical analysis, the trial will be closed to accrual.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: An asymmetric two-sided group sequential design will be used with an interim analysis for efficacy and futility.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: double-blinded, placebo-controlled
Primary Purpose: Treatment
Official Title: A Phase II Randomized Controlled Trial of a Supplement Containing Quercetin, Bromelain and Papain on Reducing the Severity of Radiation-Induced Prostatitis
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Quercetin

Arm Intervention/treatment
Active Comparator: Arm 1: Prosta-Q

Patients will be randomized in a 1:1 ratio to receive Prosta-Q, one capsule, twice daily for 4-6 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.

Drug: Prosta-Q
Prosta-Q is an over-the-counter herbal supplement manufactured by Farr Laboratories. It is a combination product composed of quercetin, cranberry, saw palmetto, bromelain, and papain.

Placebo Comparator: Arm 2: Placebo

Patients will be randomized in a 1:1 ratio to receive Placebo, one capsule, twice daily for 4-6 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.

Drug: Placebo
placebo capsule




Primary Outcome Measures :
  1. mean peak score of the National Institutes of Health‐Chronic Prostatitis Symptom Index (NIH‐CPSI) [ Time Frame: 4-6 weeks post brachytherapy ]
    difference in prostatitis symptoms between treatment and placebo group.


Secondary Outcome Measures :
  1. Sexual Health Inventory for Men (SHIM) assessment [ Time Frame: 4-6 weeks post brachytherapy ]

    Health Related Quality of Life (HRQOL) will be assessed with pre- and post- treatment SHIM questionnaires

    SHIM Scores 1-7 Severe ED 8-11 Moderate ED 12-16 Mild to Moderate ED 17-21 Mild ED 22-25 No signs of ED


  2. Impact on serum biomarkers of inflammation. Markers to include erythrocyte sedimentation rate, C-reactive protein, and prostate-specific antigen (PSA). [ Time Frame: 4-6 weeks post bracytherapy ]
    inflammation markers will be collected pre- and post-brachytherapy for comparison between treatment and placebo groups.

  3. adverse events will be characterized for frequency, type ,severity [ Time Frame: 4-6 weeks ]
    To assess safety of Prosta-Q compared to placebo.

  4. The Expanded Prostate Cancer Index Composite (EPIC) assessment [ Time Frame: 4-6 weeks post brachytherapy ]
    Health Related Quality of Life (HRQOL) will be assessed with pre- and post- treatment EPIC questionnaires. Items are standardized to a 0-100 scale and are averaged to calculate a summary score or subscale score.

  5. The International Prostate Symptom Score (I-PSS) assessment [ Time Frame: 4-6 weeks post brachytherapy ]

    Health Related Quality of Life (HRQOL) will be assessed with pre- and post- treatment I-PSS questionnaires.

    American Urological Association Symptom (AUA) Score Mild = 0-7 Moderate = 8-19 Severe = 20-35


  6. The Rectal Function Assessment Score (R-FAS) assessment [ Time Frame: 4-6 weeks post brachytherapy ]
    Health Related Quality of Life (HRQOL) will be assessed with pre- and post- treatment questionnaires. Responses to the questions are added up for a total between 0-27. Question 10 does not count toward the total score.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male subjects ≥ 18 years
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male subjects aged ≥ 18 years.
  • Men with histologically proven prostate adenocarcinoma who have selected treatment with brachytherapy with or without external beam radiation, with or without androgen deprivation therapy.
  • Fluent in speaking and reading English.
  • ECOG Performance Status ≤ 1.
  • Adequate organ function as defined as:

    • Hepatic:

      • Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)
      • AST(SGOT)/ALT(SGPT) ≤ 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 female subjects throughout the study and for at least 5 days after last study treatment administration if the risk of conception exists.
  • 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.
  • Subject has undergone transurethral resection of the prostate (TURP).
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions AND the median life expectancy is <=5 years as calculated by the Lee and Shonberg Index (https://eprognosis.ucsf.edu/leeschonberg.php)::

    • 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04252625


Contacts
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Contact: Brett Johnson 801-587-4429 brett.johnson@hci.utah.edu

Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Jonathan Tward, MD, PhD Huntsman Cancer Institute/ University of Utah
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Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT04252625    
Other Study ID Numbers: HCI129154
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Prostatitis
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Prostatic Diseases
Genital Diseases, Male