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NCT Number: NCT02366975

TRT on BPH Hypoganadal MetS Patients. Florence-PROTEST

There are many evidences in the literature showing that the metabolic syndrome (MetS) is associated with BPH / LUTS. There are also numerous evidence that hypogonadism is associated with both conditions, thus being one of the most probable pathogenetic factor underlying the association between MetS & BPH / LUTS.

Preliminary evidences from observational clinical studies have shown that treatment with testosterone replacement in hypogonadal patients with MetS reduces the symptoms of lower urinary tract symptoms (LUTS) associated with BPH. Preclinical studies performed by the investigators research group show in an experimental model of metabolic syndrome the occurrence of marked inflammation and tissue remodeling of the prostate gland, which is prevented by treatment with testosterone replacement (Vignozzi et al., 2012). There is therefore a need for a clinical trial to demonstrate the effect of treatment with testosterone replacement in reducing the inflammation of the prostate and its effectiveness in improving the symptoms related to inflammation in patients with prostatic BPH associated with metabolic syndrome and testosterone deficiency .

The aims of the present study is to evaluate the effectiveness of testosterone replacement therapy compared to placebo in reducing signs and symptoms of inflammation of the prostate and LUTS symptoms in hypogonadal patients with metabolic syndrome and BPH who are candidates for radical prostatectomy simple.

For this purpose both clinical (assessment of specific symptoms of prostatitis assessed by questionnaire National Institutes of Health Chronic Prostatitis Symptom Index, NIH-CPSI and assessment of the symptoms of LUTS and questionnaires International Prostate Symptom Score, IPSS), ultrasound (transrectal ultrasound evaluation of markers of prostatic inflammation: macrocalcifications, inhomogeneity etc.), biochemical (evaluation of inflammatory cytokines in the semen), urodynamic and histology (histomorphometric and immunohistochemical analysis of samples prostate derived from patients enrolled in the study or not treated with testosterone) scores will be performed. Along with the symptoms and clinical signs of prostate inflammation and LUTS, the effect of testosterone therapy or placebo on penile erection will be also evaluated.

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Key information

Conditions

Prostatic Hyperplasia Endocrine System Diseases Genital Diseases Genital Diseases, Male Glucose Metabolism Disorders Gonadal Disorders Hyperinsulinism Hypogonadism Insulin Resistance Lower Urinary Tract Symptoms Male Urogenital Diseases Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Signs and Symptoms Urogenital Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Ambulatori Medicina della Sessualità e Andrologia, Florence, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male subjects aged ≥ 18 years on the waiting list for simple prostatectomy for BPH
  • Diagnosis of metabolic syndrome (AHA / NHLBI) defined by the presence of three or more of the following parameters: visceral obesity (waist circumference> or = 102 cm), fasting glucose (> or = 100 mg / dL) or a history of diabetes mellitus or treatment with antidiabetic drugs, high triglycerides (> or = 150 mg / dL) or treatment, high levels of blood pressure (BP> or = 130/85 mm Hg) or drug treatment and reduced levels of HDL cholesterol (<or = 40 mg / dL) or treatment.
  • Diagnosis of prostatic inflammation defined by a score greater than 15 at the NIH-CPSI questionnaire
  • Capacity to give consent for study participation, after being adequately informed of the aims, benefits, risks, time and motion of the study

Exclusion criteria

  • Participation in another clinical trial;
  • Previous diagnosis, presence or suspected malignancy of the prostate or breast cancer;
  • PSA values10ng/mL
  • Values of hematocrit ≥ 52%
  • Use of 5alpha-reductase inhibitor drugs in the previous three months;
  • Presence of a serious organic disease or mental diagnosed by a specialist psychiatrist (eg major depression medication) suspected on the basis of medical history and / or physical examination of the patient
  • Presence of conditions that may affect the compliance to the study;
  • Presence of severe allergy or hypersensitivity to study drug (active ingredient or excipients of the formulation);

Treatment and study plan

Testosterone gel 2%

Drug

testosterone gel 2% (50mg/die).

Other names: tostran

Placebo

Other

placebo gel

Primary outcomes

  1. NIH-CPSI

    Time frame: 6 months before surgery

    Evaluation in hypogonadal patients with both BPH and metabolic syndrome of the effectiveness of 6 months of treatment with testosterone compared with placebo in improving symptoms of prostatitis and the symptoms of LUTS

  2. IPSS

    Time frame: 6 months before surgery

    Evaluation in hypogonadal patients with both BPH and metabolic syndrome of the effectiveness of 6 months of treatment with testosterone compared with placebo in improving symptoms of prostatitis and the symptoms of LUTS

Secondary outcomes

  1. ultrasound prostate characteristics

    Time frame: 6 months before surgery

    Evaluation in hypogonadal patients with both BPH and metabolic syndrome of the effectiveness of 6 months of treatment with testosterone compared with placebo in improving

  2. Immunohistological analysis of prostatic inflammation and gene expression of inflammatory markers on the prostate

    Time frame: 6 months before surgery

    Evaluation in hypogonadal patients with both BPH and metabolic syndrome of the effectiveness of 6 months of treatment with testosterone compared with placebo in improving

  3. metabolic parameters

    Time frame: 6 months before surgery

    Evaluation in hypogonadal patients with both BPH and metabolic syndrome of the effectiveness of 6 months of treatment with testosterone compared with placebo in improving

Sponsors and collaborators

Lead sponsor

University of Florence

Other

Registry information

Official study title

Effectiveness of Testosterone Replacement Therapy (TRT) on Prostatic Gland in Hypogonadal Patients Affected by Benign Prostatic Hyperplasia (BPH) and Metabolic Syndrome (MetS). Florence-PROTEST

Acronym: PROTEST

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Feb 19, 2015
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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