TRT on BPH Hypoganadal MetS Patients. Florence-PROTEST

NCT02366975 | Completed Phase 4

• 1 other identifier: 2012-003494-26
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms; Hypogonadism

Keywords

BPH/LUTS; TRT; Metabolic Syndrome

Outcome Measures

Primary Outcomes (2)

• NIH-CPSI

  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

  6 months before surgery

• IPSS

  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

  6 months before surgery

Secondary Outcomes (3)

• ultrasound prostate characteristics

  6 months before surgery

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

  6 months before surgery

• metabolic parameters

  6 months before surgery

Study Arms (3)

Eugonadal patients

NO INTERVENTION

Patients without hypogonadism has been enrollend but not randomized

Hypogonadal patients A

ACTIVE COMPARATOR

Patients with hypogonadism has been randomized to testosterone gel solution 2%

Drug: Testosterone gel 2%

Hypogonadal patients B

PLACEBO COMPARATOR

Patients with hypogonadism has been randomized to placebo solution gel

Other: Placebo

Interventions

Testosterone gel 2% DRUG

testosterone gel 2% (50mg/die).

Also known as: tostran

Hypogonadal patients A

Placebo OTHER

placebo gel

Hypogonadal patients B

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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);

Sponsors & Collaborators

• University of Florence: lead

Study Sites (2)

Ambulatori Medicina della Sessualità e Andrologia

Florence, Italy

Location

Clinica Urologica - Azienda Ospedaliero-Universitaria Careggi

Florence, Italy

Location

Related Publications (4)

• Vignozzi L, Morelli A, Sarchielli E, Comeglio P, Filippi S, Cellai I, Maneschi E, Serni S, Gacci M, Carini M, Piccinni MP, Saad F, Adorini L, Vannelli GB, Maggi M. Testosterone protects from metabolic syndrome-associated prostate inflammation: an experimental study in rabbit. J Endocrinol. 2012 Jan;212(1):71-84. doi: 10.1530/JOE-11-0289. Epub 2011 Oct 18.

  PMID: 22010203 RESULT

• Cohen PG. Benign prostatic hyperplasia: the hypogonadal-obesity-prostate connection. Med Hypotheses. 2009 Aug;73(2):142-3. doi: 10.1016/j.mehy.2009.03.013. Epub 2009 Apr 24.

  PMID: 19394149 RESULT

• Filippi S, Vignozzi L, Morelli A, Chavalmane AK, Sarchielli E, Fibbi B, Saad F, Sandner P, Ruggiano P, Vannelli GB, Mannucci E, Maggi M. Testosterone partially ameliorates metabolic profile and erectile responsiveness to PDE5 inhibitors in an animal model of male metabolic syndrome. J Sex Med. 2009 Dec;6(12):3274-88. doi: 10.1111/j.1743-6109.2009.01467.x. Epub 2009 Sep 1.

  PMID: 19732305 RESULT

• Lotti F, Corona G, Colpi GM, Filimberti E, Degli Innocenti S, Mancini M, Baldi E, Noci I, Forti G, Adorini L, Maggi M. Elevated body mass index correlates with higher seminal plasma interleukin 8 levels and ultrasonographic abnormalities of the prostate in men attending an andrology clinic for infertility. J Endocrinol Invest. 2011 Nov;34(10):e336-42. doi: 10.3275/7855. Epub 2011 Jul 7.

  PMID: 21738005 RESULT

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms; Hypogonadism; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gonadal Disorders; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• mario maggi

  University of Florence

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Endocrinology

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: February 19, 2015
• Study Start: November 1, 2012
• Primary Completion: January 1, 2017
• Study Completion: February 1, 2017
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

IT (2)