Prostatic HyperplasiaPhase 4PROTESTNCT02366975
TRT on BPH Hypoganadal MetS Patients. Florence-PROTEST
A Phase 4 study testing Testosterone gel 2% in people with Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by University of Florence at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Hypogonadism
- What is being tested?
- Testosterone gel 2%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 143 participants
- Where
- 2 sitesItaly
- Study dates
- Nov 2012to Feb 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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);
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Ambulatori Medicina della Sessualità e Andrologia
Florence
Clinica Urologica - Azienda Ospedaliero-Universitaria Careggi
Florence
About this study
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
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 .
Read more
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.
- Being tested
- Testosterone gel 2%, Placebo
- Keywords
- BPH/LUTS, TRT, Metabolic Syndrome
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Hypogonadism, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone gel 2%Drug
Also called tostran
testosterone gel 2% (50mg/die).
PlaceboOther
placebo gel
| Study group | Role | What they receive |
|---|---|---|
| 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% Receives: Drug: Testosterone gel 2% |
| Hypogonadal patients B | Placebo comparator | Patients with hypogonadism has been randomized to placebo solution gel Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6 months before surgery
Secondary outcomes (3)
ultrasound prostate characteristics
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
Measured: 6 months before surgery
Immunohistological analysis of prostatic inflammation and gene expression of inflammatory markers on the prostate
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
Measured: 6 months before surgery
metabolic parameters
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
Measured: 6 months before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startNov 2012
- Primary completionJan 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Maggi, University of Florence
- Investigators
- mario maggi, Principal investigator, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366975
- Sponsor's protocol ID
- 2012-003494-26
- Acronym
- PROTEST
- Status last verified
- Oct 2017
- First submitted
- 11 Dec 2014
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22010203Cohen 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.
PubMed 19394149Filippi 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.
PubMed 19732305Lotti 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.
PubMed 21738005
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02366975
- Acronym / sponsor ID
- PROTEST / 2012-003494-26
- Keywords
- BPH/LUTS, TRT, Metabolic Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jan 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 19 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eugonadal patients | No intervention | –Patients without hypogonadism has been enrollend but not randomized |
| Hypogonadal patients A | Active comparator | Drug: Testosterone gel 2%Patients with hypogonadism has been randomized to testosterone gel solution 2% |
| Hypogonadal patients B | Placebo comparator | Other: PlaceboPatients with hypogonadism has been randomized to placebo solution gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testosterone gel 2%Also: tostrantestosterone gel 2% (50mg/die). | Drug | Hypogonadal patients A |
| Placeboplacebo gel | Other | Hypogonadal patients B |
Primary outcome
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
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
3 secondary outcomes
ultrasound prostate characteristics
Time frame: 6 months before surgery
Immunohistological analysis of prostatic inflammation and gene expression of inflammatory markers on the prostate
Time frame: 6 months before surgery
metabolic parameters
Time frame: 6 months before surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Results publication: PubMed 22010203Vignozzi 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.
- Results publication: PubMed 19394149Cohen 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.
- Results publication: PubMed 19732305Filippi 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.
- Results publication: PubMed 21738005Lotti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mario maggi principal investigator
University of Florence
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Testosterone gel 2% in people with Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by University of Florence at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIH-CPSI (time frame: 6 months before surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02366975, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.