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TRT on BPH Hypoganadal MetS Patients. Florence-PROTEST (PROTEST)

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ClinicalTrials.gov Identifier: NCT02366975
Recruitment Status : Completed
First Posted : February 19, 2015
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Mario Maggi, University of Florence

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.


Condition or disease Intervention/treatment Phase
Prostatic Hyperplasia Lower Urinary Tract Symptoms Hypogonadism Drug: Testosterone gel 2% Other: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : November 2012
Actual Primary Completion Date : January 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Eugonadal patients
Patients without hypogonadism has been enrollend but not randomized
Active Comparator: Hypogonadal patients A
Patients with hypogonadism has been randomized to testosterone gel solution 2%
Drug: Testosterone gel 2%
testosterone gel 2% (50mg/die).
Other Name: tostran

Placebo Comparator: Hypogonadal patients B
Patients with hypogonadism has been randomized to placebo solution gel
Other: Placebo
placebo gel




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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);

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02366975


Locations
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Italy
Ambulatori Medicina della Sessualità e Andrologia
Florence, Italy
Clinica Urologica - Azienda Ospedaliero-Universitaria Careggi
Florence, Italy
Sponsors and Collaborators
University of Florence
Investigators
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Principal Investigator: mario maggi University of Florence

Publications of Results:
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Responsible Party: Mario Maggi, Full Professor of Endocrinology, University of Florence
ClinicalTrials.gov Identifier: NCT02366975     History of Changes
Other Study ID Numbers: 2012-003494-26
First Posted: February 19, 2015    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Keywords provided by Mario Maggi, University of Florence:
BPH/LUTS
TRT
Metabolic Syndrome
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hypogonadism
Hyperplasia
Lower Urinary Tract Symptoms
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Gonadal Disorders
Endocrine System Diseases
Urological Manifestations
Signs and Symptoms
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents