Proof-of-concept Study to Evaluate the Safety and Efficacy of Tryptophan in Patients With BPH.

Study Overview
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Brief Summary
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Benign prostatic hyperplasia (BPH) is one of the most prevalent human diseases and a major cause of lower urinary tract symptoms (LUTS). Some men respond to current medical treatment (mainly α-1 adrenoreceptor antagonists and 5 α-reductase inhibitors), but a large proportion of patients continues to need a surgical procedure to treat resistant LUTS or even more serious complications of BPH, creating the emerging necessity for novel pharmacological therapies. Oxitriptan may have a possible positive effect on BPH associated symptoms with probably no impact in sexual function (which is a common side effect of the current drugs for BPH associated symptoms). Also, improvement in symptoms could be higher than that of current drugs used for this condition. This is a single-center parallel group, randomized clinical trial. The study will take place in Hospital de Braga (Urology department). Eligible patients will be randomized to receive tamsulosin 0.4mg (once a day, q.d.) or 5-HTP (5-hidroxitriptophan) 100mg (three times a day, t.i.d.), for 6 months.

Official Title
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TryptoBPH - Proof-of-concept Study to Evaluate the Safety and Efficacy of Tryptophan in Patients With BPH.

Conditions
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BPH

Intervention / Treatment
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* Drug: Tamsulosin
* Drug: 5-hidroxitriptophan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent; Male patients with BPH for which tamsulosin is the therapeutic option per SoC; Aged ≥50 and less than 75 years old; With prostate volume ≥30 cm3 by TRUS; Diagnosed with LUTS defined by a stable IPSS total score ≥13 points. Exclusion Criteria: patients with post-void bladder residual volume ≥250 ml; TryptoBPH Version 1.4 (December 6th, 2021) Page 8 of 45 patients with intravesical obstruction from any cause other than BPH; history of any procedure considered an intervention for BPH; patients with active urinary tract infection; history of recurrent urinary tract infections; current prostatitis or diagnosis of chronic prostatitis; history of prostate or invasive bladder cancer; use of 5 α-reductase inhibitors within 6 months; phytotherapy within 2 weeks before entry; use of serotonin reuptake inhibitors or monoamine oxidase inhibitors; patients with acute or chronic kidney failure; patients with diagnosed or suspicion of intolerance to lactose; patients submitted to general anesthesia in the past 4 weeks; known intellectual disability that may hampers giving informed consent and would make the patient inappropriate for entry into this study, in the judgment of the investigator.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control arm<br>tamsulosin 0.4mg (once a day) for 6 months. | Drug: Tamsulosin<br>* Oral medication, once a day for 6 months.<br>|
| Experimental: Experimental arm<br>5-hidroxitriptophan 100 mg (3 times a day) for 6 months. | Drug: 5-hidroxitriptophan<br>* Oral medication, 3 times a day for 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Prostate Symptom Score (IPSS) | Evaluate the effect of tryptophan supplementation on lower urinary tract symptoms (LUTS) | Change from baseline to day 1, 1-month, 3- month and EOT (6-month) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qmax | Urine maximum flow rate | Change from baseline to EOT (6-month) | 
| IIEF-5 | Erectile function, assessed by International Index of Erectile Function-5 (IIEF-5) | Change from baseline to EOT (6-month) | 
| Prostate volume | Prostate volume (in cc), assessed by trans-rectal ultra-sound | Change from baseline to EOT (6-month) | 
| question 8 of the IPSS | quality of life due to urinary symptoms (question 8 of the IPSS). | Change from baseline to EOT (6-month) |