Proof-of-concept Study to Evaluate the Safety and Efficacy of Tryptophan in Patients with BPH. (TryptoBPH)

Clinical Academic Center (2CA-Braga)

Status and phase: Enrolling; Phase 2

Conditions: BPH; LUTS(Lower Urinary Tract Symptoms)

Treatments: Drug: 5-hidroxitriptophan; Drug: Tamsulosin

Study type: Interventional

Funder types: Other

Identifiers

NCT05401032

2024-519076-75-00 (EU Trial (CTIS) Number)

TryptoBPH

2021-000946-16 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: Male

Ages: 50 to 74 years old

Volunteers: No Healthy Volunteers

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;
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Control arm

Active Comparator group

Description:

tamsulosin 0.4mg (once a day) for 6 months.

Treatment:

Drug: Tamsulosin

Experimental arm

Experimental group

Description:

5-hidroxitriptophan 100 mg (3 times a day) for 6 months.

Treatment:

Drug: 5-hidroxitriptophan