Prostate Adenocarcinoma
Conditions
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.
Interventions
DRUGQ-Urol
Q-Urol is an over-the-counter herbal supplement manufactured by Farr Laboratories. It is a combination product composed of quercetin, pollen extract, bromelain, and papain.
DRUGPlacebo
placebo capsule
Sponsors
University of Utah
Farr Labs, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
double-blinded, placebo-controlled
Intervention model description
An asymmetric two-sided group sequential design will be used with an interim analysis for efficacy and futility.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Expanded Prostate Cancer Index Composite (EPIC) Assessment | up to 6 weeks after the start of study treatment | Health Related Quality of Life (HRQOL) will be assessed with EPIC questionnaires. Items are standardized to a 0-100 scale and are averaged to calculate four subscale scores (Urinary Summary, Bowel Summary, Sexual Summary, Hormonal Summary). A higher score (max 100) represents better HRQOL, and a lower score (min 0) represents worse HRQOL. |
| The International Prostate Symptom Score (I-PSS) Assessment | up to 6 weeks after the start of study treatment | Health Related Quality of Life (HRQOL) will be assessed with International Prostate Symptom Score (I-PSS). This is a questionnaire with 7 questions concerning urinary symptoms (from 0 to 5). A high score (max 35) indicates worse HRQOL and a low score (min 0) represents a better HRQOL. These score are reported as Mild (0-7), moderate (8-19) or Severe (20-35). total score ranges from 0 to 35 (asymptomatic to very symptomatic). |
| The Rectal Function Assessment Score (R-FAS) Assessment | At the End of Treatment Visit, up to 8 weeks after initiation of study treatment. | Health Related Quality of Life (HRQOL) will be assessed with the R-FAS 10-item questionnaires. Question 10 does not count toward the total score. 9 questions are scored from 0-3. A higher score represents poorer bowel function (max 27) and a lower score represents better bowel function (min 0). |
| Sexual Health Inventory for Men (SHIM) Assessment | At the End of Treatment Visit, up to 8 weeks after initiation of study treatment. | The SHIM is a 5 point questionnaire with ratings from 0-5 to assess Health Related Quality of Life (HRQOL). The sum of the SHIM score is categorized to Severe Erectile Dysfunction ED (0-7), Moderate ED (8-11), Mild to Moderate ED (12-16), Mild ED (17-21), No signs of ED (22-25). This outcome will report the count of participants in each category. |
| 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. | The inflammation marker, erythrocyte sedimentation rate (ESR), was collected at the End of Treatment visit for comparison between treatment and placebo groups. This outcome will report the mean ESR of each arm. |
| Impact on Serum Biomarkers of Inflammation - C-reactive Protein | At the End of Treatment Visit, up to 8 weeks after initiation of study treatment. | The inflammation marker, C-reactive protein, was collected at the End of Treatment visit for comparison between treatment and placebo groups. This outcome will report the mean C-reactive protein of each arm. |
| 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. | The inflammation marker, Prostate-specific antigen (PSA), was collected at the End of Treatment visit for comparison between treatment and placebo arm. This outcome will report the mean PSA of each arm. |
| Adverse Events by Grade | up to 10.5 weeks after initiation of study treatment | To assess safety of Q-Urol compared to placebo. The severity of adverse events was assessed using CTCAE v5.0 criteria, a 1-5 scale with higher numbers indicating greater severity. Grade 1 indicates "mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated" and Grade 5 indicates "death related to AE". This outcome measure will report the following: The count of participants who had a grade 1-2 event, related to study treatment. The count of the participants who had a grade 3-4 event, related to study treatment. The count of the participants who had a grade 5 event or higher. Subjects were monitored for adverse events from the start of treatment until 30 days after the last dose of study treatment. |
| Days of Pain Medication | up to 28 days after initiation of study treatment | To assess effect on prostatitis-related pain in men with localized prostate cancer following brachytherapy taking Q-Urol relative to placebo. This outcome will report the mean number of days participants took pain medication as documented on a self reported Pain Management Diary. This was followed for 28 days; the minimum number of days is 0 and the maximum number is 28. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJonathan Tward, MD, PhD
Huntsman Cancer Institute/ University of Utah
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: Q-Urol Patients were randomized in a 1:1 ratio to receive Q-Urol, two capsules, twice daily for 6 weeks after brachytherapy placement.
Questionnaires were 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.
Q-Urol: Q-Urol is an over-the-counter herbal supplement manufactured by Farr Laboratories. It is a combination product composed of quercetin, pollen extract, bromelain, and papain. | 5 |
| Arm 2: Placebo Patients were randomized in a 1:1 ratio to receive Placebo, two capsules, twice daily for 6 weeks after brachytherapy placement.
Questionnaires were 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.
Placebo: placebo capsule | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | Arm 1: Q-Urol | Arm 2: Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 3 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 2 Participants | 6 Participants |
| Age, Continuous | 62.60 years STANDARD_DEVIATION 6.88 | 64.00 years STANDARD_DEVIATION 7.81 | 63.30 years STANDARD_DEVIATION 6.98 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 5 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 4 Participants | 9 Participants |
| Region of Enrollment United States | 5 participants | 5 participants | 10 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 5 / 5 | 5 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
Primary
National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI)
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.
Time frame: up to 6 weeks after the start of study treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Q-Urol | National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) | Pain Score | 4.00 score on a scale | Standard Deviation 4.24 |
| Arm 1: Q-Urol | National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) | Urinary Symptoms Score | 6.00 score on a scale | Standard Deviation 2.55 |
| Arm 1: Q-Urol | National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) | Total Score | 14.80 score on a scale | Standard Deviation 6.38 |
| Arm 1: Q-Urol | National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) | Quality of life impact Score | 4.80 score on a scale | Standard Deviation 1.3 |
| Arm 1: Q-Urol | National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) | Pain score and urinary Score | 10 score on a scale | Standard Deviation 5.24 |
| Arm 2: Placebo | National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) | Pain Score | 5.8 score on a scale | Standard Deviation 4.27 |
| Arm 2: Placebo | National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) | Urinary Symptoms Score | 4.60 score on a scale | Standard Deviation 2.51 |
| Arm 2: Placebo | National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) | Pain score and urinary Score | 10.4 score on a scale | Standard Deviation 5.13 |
| Arm 2: Placebo | National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) | Quality of life impact Score | 5.20 score on a scale | Standard Deviation 2.59 |
| Arm 2: Placebo | National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) | Total Score | 15.60 score on a scale | Standard Deviation 7.09 |
Secondary
Adverse Events by Grade
To assess safety of Q-Urol compared to placebo. The severity of adverse events was assessed using CTCAE v5.0 criteria, a 1-5 scale with higher numbers indicating greater severity. Grade 1 indicates mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated and Grade 5 indicates death related to AE. This outcome measure will report the following: The count of participants who had a grade 1-2 event, related to study treatment. The count of the participants who had a grade 3-4 event, related to study treatment. The count of the participants who had a grade 5 event or higher. Subjects were monitored for adverse events from the start of treatment until 30 days after the last dose of study treatment.
Time frame: up to 10.5 weeks after initiation of study treatment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1: Q-Urol | Adverse Events by Grade | Grade 1-2 | 5 Participants |
| Arm 1: Q-Urol | Adverse Events by Grade | Grade 3-4 | 0 Participants |
| Arm 1: Q-Urol | Adverse Events by Grade | Grade 5 | 0 Participants |
| Arm 2: Placebo | Adverse Events by Grade | Grade 3-4 | 0 Participants |
| Arm 2: Placebo | Adverse Events by Grade | Grade 5 | 0 Participants |
| Arm 2: Placebo | Adverse Events by Grade | Grade 1-2 | 5 Participants |
Secondary
Days of Pain Medication
To assess effect on prostatitis-related pain in men with localized prostate cancer following brachytherapy taking Q-Urol relative to placebo. This outcome will report the mean number of days participants took pain medication as documented on a self reported Pain Management Diary. This was followed for 28 days; the minimum number of days is 0 and the maximum number is 28.
Time frame: up to 28 days after initiation of study treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Q-Urol | Days of Pain Medication | 6.00 Pain Medication days | Standard Deviation 6.75 |
| Arm 2: Placebo | Days of Pain Medication | 5.20 Pain Medication days | Standard Deviation 6.3 |
Secondary
Impact on Serum Biomarkers of Inflammation - C-reactive Protein
The inflammation marker, C-reactive protein, was collected at the End of Treatment visit for comparison between treatment and placebo groups. This outcome will report the mean C-reactive protein of each arm.
Time frame: At the End of Treatment Visit, up to 8 weeks after initiation of study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Q-Urol | Impact on Serum Biomarkers of Inflammation - C-reactive Protein | 0.14 mg/dL | Standard Deviation 0.11 |
| Arm 2: Placebo | Impact on Serum Biomarkers of Inflammation - C-reactive Protein | 0.48 mg/dL | Standard Deviation 0.62 |
Secondary
Impact on Serum Biomarkers of Inflammation - Erythrocyte Sedimentation Rate (ESR)
The inflammation marker, erythrocyte sedimentation rate (ESR), was collected at the End of Treatment visit for comparison between treatment and placebo groups. This outcome will report the mean ESR of each arm.
Time frame: At the End of Treatment Visit, up to 8 weeks after initiation of study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Q-Urol | Impact on Serum Biomarkers of Inflammation - Erythrocyte Sedimentation Rate (ESR) | 4.50 mm/hour | Standard Deviation 1.73 |
| Arm 2: Placebo | Impact on Serum Biomarkers of Inflammation - Erythrocyte Sedimentation Rate (ESR) | 2.50 mm/hour | Standard Deviation 1.73 |
Secondary
Impact on Serum Biomarkers of Inflammation - Prostate-specific Antigen (PSA)
The inflammation marker, Prostate-specific antigen (PSA), was collected at the End of Treatment visit for comparison between treatment and placebo arm. This outcome will report the mean PSA of each arm.
Time frame: At the End of Treatment Visit, up to 8 weeks after initiation of study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Q-Urol | Impact on Serum Biomarkers of Inflammation - Prostate-specific Antigen (PSA) | 1.11 ng/ml | Standard Deviation 0.9 |
| Arm 2: Placebo | Impact on Serum Biomarkers of Inflammation - Prostate-specific Antigen (PSA) | 1.87 ng/ml | Standard Deviation 0.92 |
Secondary
Sexual Health Inventory for Men (SHIM) Assessment
The SHIM is a 5 point questionnaire with ratings from 0-5 to assess Health Related Quality of Life (HRQOL). The sum of the SHIM score is categorized to Severe Erectile Dysfunction ED (0-7), Moderate ED (8-11), Mild to Moderate ED (12-16), Mild ED (17-21), No signs of ED (22-25). This outcome will report the count of participants in each category.
Time frame: At the End of Treatment Visit, up to 8 weeks after initiation of study treatment.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1: Q-Urol | Sexual Health Inventory for Men (SHIM) Assessment | Severe Erectile Dysfunction ED (0-7) | 3 Participants |
| Arm 1: Q-Urol | Sexual Health Inventory for Men (SHIM) Assessment | Moderate ED (8-11) | 0 Participants |
| Arm 1: Q-Urol | Sexual Health Inventory for Men (SHIM) Assessment | Mild to Moderate ED (12-16) | 0 Participants |
| Arm 1: Q-Urol | Sexual Health Inventory for Men (SHIM) Assessment | Mild ED (17-21) | 0 Participants |
| Arm 1: Q-Urol | Sexual Health Inventory for Men (SHIM) Assessment | No signs of ED (22-25) | 1 Participants |
| Arm 1: Q-Urol | Sexual Health Inventory for Men (SHIM) Assessment | Not assessed | 1 Participants |
| Arm 2: Placebo | Sexual Health Inventory for Men (SHIM) Assessment | Severe Erectile Dysfunction ED (0-7) | 3 Participants |
| Arm 2: Placebo | Sexual Health Inventory for Men (SHIM) Assessment | No signs of ED (22-25) | 0 Participants |
| Arm 2: Placebo | Sexual Health Inventory for Men (SHIM) Assessment | Moderate ED (8-11) | 1 Participants |
| Arm 2: Placebo | Sexual Health Inventory for Men (SHIM) Assessment | Mild ED (17-21) | 1 Participants |
| Arm 2: Placebo | Sexual Health Inventory for Men (SHIM) Assessment | Mild to Moderate ED (12-16) | 0 Participants |
| Arm 2: Placebo | Sexual Health Inventory for Men (SHIM) Assessment | Not assessed | 0 Participants |
Secondary
The Expanded Prostate Cancer Index Composite (EPIC) Assessment
Health Related Quality of Life (HRQOL) will be assessed with EPIC questionnaires. Items are standardized to a 0-100 scale and are averaged to calculate four subscale scores (Urinary Summary, Bowel Summary, Sexual Summary, Hormonal Summary). A higher score (max 100) represents better HRQOL, and a lower score (min 0) represents worse HRQOL.
Time frame: up to 6 weeks after the start of study treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Q-Urol | The Expanded Prostate Cancer Index Composite (EPIC) Assessment | Urinary Summary | 68.62 score on a scale | Standard Deviation 10.89 |
| Arm 1: Q-Urol | The Expanded Prostate Cancer Index Composite (EPIC) Assessment | Sexual Summary | 26.44 score on a scale | Standard Deviation 40.81 |
| Arm 1: Q-Urol | The Expanded Prostate Cancer Index Composite (EPIC) Assessment | Bowel Summary | 85.36 score on a scale | Standard Deviation 12.01 |
| Arm 1: Q-Urol | The Expanded Prostate Cancer Index Composite (EPIC) Assessment | Hormonal Summary | 72.02 score on a scale | Standard Deviation 17.81 |
| Arm 2: Placebo | The Expanded Prostate Cancer Index Composite (EPIC) Assessment | Hormonal Summary | 75.03 score on a scale | Standard Deviation 12.42 |
| Arm 2: Placebo | The Expanded Prostate Cancer Index Composite (EPIC) Assessment | Urinary Summary | 64.44 score on a scale | Standard Deviation 15.87 |
| Arm 2: Placebo | The Expanded Prostate Cancer Index Composite (EPIC) Assessment | Bowel Summary | 84.37 score on a scale | Standard Deviation 11.42 |
| Arm 2: Placebo | The Expanded Prostate Cancer Index Composite (EPIC) Assessment | Sexual Summary | 23.71 score on a scale | Standard Deviation 17.22 |
Secondary
The International Prostate Symptom Score (I-PSS) Assessment
Health Related Quality of Life (HRQOL) will be assessed with International Prostate Symptom Score (I-PSS). This is a questionnaire with 7 questions concerning urinary symptoms (from 0 to 5). A high score (max 35) indicates worse HRQOL and a low score (min 0) represents a better HRQOL. These score are reported as Mild (0-7), moderate (8-19) or Severe (20-35). total score ranges from 0 to 35 (asymptomatic to very symptomatic).
Time frame: up to 6 weeks after the start of study treatment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1: Q-Urol | The International Prostate Symptom Score (I-PSS) Assessment | Mild | 0 Participants |
| Arm 1: Q-Urol | The International Prostate Symptom Score (I-PSS) Assessment | Moderate | 2 Participants |
| Arm 1: Q-Urol | The International Prostate Symptom Score (I-PSS) Assessment | Severe | 3 Participants |
| Arm 2: Placebo | The International Prostate Symptom Score (I-PSS) Assessment | Mild | 0 Participants |
| Arm 2: Placebo | The International Prostate Symptom Score (I-PSS) Assessment | Moderate | 4 Participants |
| Arm 2: Placebo | The International Prostate Symptom Score (I-PSS) Assessment | Severe | 1 Participants |
Secondary
The Rectal Function Assessment Score (R-FAS) Assessment
Health Related Quality of Life (HRQOL) will be assessed with the R-FAS 10-item questionnaires. Question 10 does not count toward the total score. 9 questions are scored from 0-3. A higher score represents poorer bowel function (max 27) and a lower score represents better bowel function (min 0).
Time frame: At the End of Treatment Visit, up to 8 weeks after initiation of study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Q-Urol | The Rectal Function Assessment Score (R-FAS) Assessment | 5.20 Score on a scale | Standard Deviation 2.95 |
| Arm 2: Placebo | The Rectal Function Assessment Score (R-FAS) Assessment | 3.60 Score on a scale | Standard Deviation 3.36 |