Benign Prostatic HyperplasiaPhase 3PARTEMNCT02869971
Prostatic Artery Embolization Versus Medical Treatment in Symptomatic Benign Prostatic Hyperplasia
A Phase 3 study testing Embosphere® (Prostatic Arteries Embolization) and Drug therapy in people with Benign Prostatic Hyperplasia, run by Assistance Publique - Hôpitaux de Paris at 13 sites in France.
Trial summary
The primary objective of this trial is to compare the 9-month effect on lower urinary tract symptoms (LUTS) of Prostatic Artery Embolization (PAE) using Embosphere® versus Standard Combined Therapy (alpha-blockers plus 5 alpha-reductase inhibitors) in patients with symptomatic BPH who failed after a first line medical… Read more about this study
- Who is it for?
- Ages 50 to 85 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Embosphere® (Prostatic Arteries Embolization) and Drug therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 13 sitesFrance
- Study dates
- Aug 2016to 25 Mar 2022
- Phase
- Phase 3
- 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 50 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men aged>= 50 and <=85 years AND
- Moderate to severe LUTS defined as IPSS > 11, and QoL > 3 AND
- No improvement after an alpha blocker treatment line (Tamsulosin 0.4 mg p.d. during 1 month) AND
- Prostatic volume >=50 ml AND
- Affiliated to a French health insurance system
Who cannot join
- Severe allergy to iodine contrast agent
- Treatment with 5-ARI on the last 6 months
- Suspected prostate cancer requiring specific management
- On-going prostatitis
- On-going urinary retention
- On-going acute urinary infection
Show all 21Show fewer
- Acontractile detrusor
- Neurogenic lower urinary tract dysfunction
- Urethral stenosis
- Bladder diverticulum
- Bladder stone with surgical indication
- Patient refusing PAE
- Creatinine clearance <40 ml/min
- Severe liver failure
- Contra-indication to alpha-blockers
- Hypersensitivity to dutasteride, other 5-alpha reductase inhibitors, tamsulosin (including case of tamsulosin induced angioedema), soya, peanut or one of the excipients
- Hypersensitivity to gelatin or collagen
- Patients ineligible for pelvic angiography
- History of orthostatic hypotension
- Patient unable or unwilling to provide written informed consent
- Patient under legal protection
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
CHU de Bordeaux groupe hospitalier Pellegrin
Bordeaux, New Aquitaine, 33076
AP-HP hopital Henri-Mondor
Créteil, Île-de-France Region, 94010
CHU de Limoges
Limoges, New Aquitaine, 87042
CHU de Lyon hopital Edouard Herriot
Lyon, Auvergne-Rhône-Alpes, 69437
AP-HM hopital la Conception
Marseille, Provence-Alpes-Côte d'Azur Region, 13005
AP-HM hopital de la Timone
Marseille, Provence-Alpes-Côte d'Azur Region, 13385
CHU Montpellier hopital Arnaud de Villeneuve
Montpellier, Occitanie, 34295
CHU Montpellier hopital Lapeyronie
Montpellier, Occitanie, 34295
AP-HP - Hôpital Saint-Louis
Paris, Île-de-France Region, 75010
AP-HP hopital Cochin
Paris, Île-de-France Region, 75014
AP-HP Hopital Europeen Georges Pompidou
Paris, Île-de-France Region, 75908
CHU de Lyon centre hospitalier Lyon Sud
Pierre-Bénite, Auvergne-Rhône-Alpes, 69310
CHU Rennes hopital Pontchaillou
Rennes, Brittany Region, 35033
About this study
The primary objective of this trial is to compare the 9-month effect on lower urinary tract symptoms (LUTS) of Prostatic Artery Embolization (PAE) using Embosphere® versus Standard Combined Therapy (alpha-blockers plus 5 alpha-reductase inhibitors) in patients with symptomatic BPH who failed after a first line medical treatment with alpha-blockers.
The secondary objectives of this study are to:
- Estimate the impact of the 2 strategies on benign prostatic hyperplasia specific Health Status (i.e. urinary and sexual signs and symptoms) at 3, 9, 18, and 24 months, as well as the side effects of the 2 strategies;
- Report the safety of PAE;
- Evaluate patient's adherence to medical treatment;
- Analyse the costs of each strategy and report the incremental efficiency (incremental cost utility ratio) of prostatic artery embolization compared to medical treatment.
Read the detailed description
Benign Prostatic Hyperplasia (BPH) is the primary cause of lower urinary tract symptoms (LUTS) and affects > 50% of men >60 years. Moderate to severe symptoms prevalence is around 14% in France, and the proportion of men with moderate to severe symptoms doubles with each decade of age. The first-line treatment of bothersome BPH-related LUTS is medical therapy as recommended by French and European guidelines. 5α reductase inhibitors (5-ARI) can be combined with alpha-blockers and allow reduction of the size of the prostate and LUTS improvement. The severity of symptoms is usually assessed using the International prostate symptom score (IPSS) which is the standard questionnaire for the objective assessment of LUTS.
Recently, Prostatic Artery Embolization (PAE) has been proposed to treat symptomatic BPH with good safety and efficacy in single-centre studies (12-point IPSS reduction at 3 months maintained up to one year. In a randomized trial comparing PAE versus transurethral resection of prostate (TURP), Gao reported a 16-point IPSS reduction at 6 months, and an increase in the maximum urinary flow rate (Qmax) comprised between 12 ml/s and 24 ml/s at 6 months and up to 21 ml/s at 2 years. The complication rate is low (a few cases of bladder ulcer have been published) and the patient generally experiences mild post-embolization symptoms for few days.
PAE can be performed during a one-day hospitalisation and could be very attractive to patients which have insufficient benefit of medical treatment or who have side effects affecting their quality of life. The most used device for PAE is Embosphere® (Merit Medical). It bears the European CE (Conforme aux Exigences) marking for this specific indication and approximately 500 patients have been treated with it worldwide. Nonetheless, no big randomized study has proven its efficacy compared with best medical treatment. A study comparing PAE using Embosphere® and surgery (TURP) is currently enrolling patients; no patients could be included in France because men with BPH refused to be potentially assigned the surgical arm.
To properly evaluate PAE, the investigators designed the PARTEM trial, which has received the support of both the Societe Francaise de Radiologie (French society of radiology) and of the Association Francaise d'Urologie (French association of urology).
PARTEM will compare prospectively the benefit of PAE using Embosphere® to the benefit of combined medical treatment (Combodart®: Dutasteride 0.5mg Tamsulosin 0.4mg) at 9 months with an extended follow up at 24 months in order to evaluate the stability of results in both groups.
The investigators plan a multicentre, prospective, randomized, open label, parallel trial, comparing PAE to Combined Therapy (CT: alpha-blockers + 5-ARI treatment). Treatments will be allocated by minimization with a 1:1 ratio, based on study centre, IPSS score (moderate/severe) and prostate volume (< 80 g/≥80 g).
This study is designed to demonstrate the superiority of PAE to decrease LUTS compared to best medical treatment.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Embosphere® (Prostatic Arteries Embolization), Drug therapy
- Keywords
- Prostatic artery embolization, Combined Therapy, IPSS
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embosphere® (Prostatic Arteries Embolization)Device
Prostatic Arteries Embolization with 300-500 µm trisacryl microspheres
Drug therapyDrug
Combodart (dutasteride 0.5 mg/tamsulosin 0.4 mg)
| Study group | Role | What they receive |
|---|---|---|
| Embolization | Experimental | Prostatic Arteries Embolization Receives: Device: Embosphere® (Prostatic Arteries Embolization) |
| Combined Therapy | Active comparator | Combodart® : dutasteride 0.5 mg/tamsulosin 0.4 mg per day Receives: Drug: Drug therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IPSS score
Measured: 9 months
Secondary outcomes (12)
Number of Adverse Events
Measured: 3, 9, 18, 24 months
IPSS
Measured: 3, 18, 24 months
Qmax
Measured: 3, 9, 24 months
International Index of Erectile Function (IIEF) score
Measured: 3, 9, 18, 24 months
prostate volume
Measured: 3, 9, 24 months
Prostate-Specific Antigen (PSA) level
Measured: 3, 9, 18, 24 months
Quality of life score
assessed by IPSS/Quality of Life (QoL) form
Measured: 3, 9, 18, 24 months
Treatment units' account
adherence to treatment
Measured: 3, 9 months
Adherence to treatment questionnaire
adherence to treatment
Measured: 3, 9 months
number of PAE
Measured: 24 months
number of surgical treatment
Measured: 24 months
number of medication
Measured: 3, 9, 18, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startAug 2016
- Primary completion3 Dec 2020
- Study completion25 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Marc Sapoval, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869971
- Sponsor's protocol ID
- P150917
- Other IDs
- PHRC-15-521, 2016-A00247-44
- Acronym
- PARTEM
- Status last verified
- Apr 2022
- First submitted
- 19 Jul 2016
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Sapoval M, Thiounn N, Descazeaud A, Dean C, Ruffion A, Pagnoux G, Duarte RC, Robert G, Petitpierre F, Karsenty G, Vidal V, Murez T, Vernhet-Kovacsik H, de la Taille A, Kobeiter H, Mathieu R, Heautot JF, Droupy S, Frandon J, Barry Delongchamps N, Korb-Savoldelli V, Durand-Zaleski I, Pereira H, Chatellier G; PARTEM study group. Prostatic artery embolisation versus medical treatment in patients with benign prostatic hyperplasia (PARTEM): a randomised, multicentre, open-label, phase 3, superiority trial. Lancet Reg Health Eur. 2023 Jun 26;31:100672. doi: 10.1016/j.lanepe.2023.100672. eCollection 2023 Aug.
PubMed 37415648
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostatic Artery Embolization Versus Medical Treatment in Symptomatic Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT02869971
- Acronym / sponsor ID
- PARTEM / P150917
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Prostatic artery embolization, Combined Therapy, IPSS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Aug 2016 (actual)
- Primary completion
- 3 Dec 2020 (actual)
- Study completion
- 25 Mar 2022 (actual)
- First posted
- 17 Aug 2016 (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.
The primary objective of this trial is to compare the 9-month effect on lower urinary tract symptoms (LUTS) of Prostatic Artery Embolization (PAE) using Embosphere® versus Standard Combined Therapy (alpha-blockers plus 5 alpha-reductase inhibitors) in patients with symptomatic BPH who failed after a first line medical treatment with alpha-blockers.
The secondary objectives of this study are to:
- Estimate the impact of the 2 strategies on benign prostatic hyperplasia specific Health Status (i.e. urinary and sexual signs and symptoms) at 3, 9, 18, and 24 months, as well as the side effects of the 2 strategies;
- Report the safety of PAE;
- Evaluate patient's adherence to medical treatment;
- Analyse the costs of each strategy and report the incremental efficiency (incremental cost utility ratio) of prostatic artery embolization compared to medical treatment.
Detailed description
Benign Prostatic Hyperplasia (BPH) is the primary cause of lower urinary tract symptoms (LUTS) and affects > 50% of men >60 years. Moderate to severe symptoms prevalence is around 14% in France, and the proportion of men with moderate to severe symptoms doubles with each decade of age. The first-line treatment of bothersome BPH-related LUTS is medical therapy as recommended by French and European guidelines. 5α reductase inhibitors (5-ARI) can be combined with alpha-blockers and allow reduction of the size of the prostate and LUTS improvement. The severity of symptoms is usually assessed using the International prostate symptom score (IPSS) which is the standard questionnaire for the objective assessment of LUTS.
Recently, Prostatic Artery Embolization (PAE) has been proposed to treat symptomatic BPH with good safety and efficacy in single-centre studies (12-point IPSS reduction at 3 months maintained up to one year. In a randomized trial comparing PAE versus transurethral resection of prostate (TURP), Gao reported a 16-point IPSS reduction at 6 months, and an increase in the maximum urinary flow rate (Qmax) comprised between 12 ml/s and 24 ml/s at 6 months and up to 21 ml/s at 2 years. The complication rate is low (a few cases of bladder ulcer have been published) and the patient generally experiences mild post-embolization symptoms for few days.
PAE can be performed during a one-day hospitalisation and could be very attractive to patients which have insufficient benefit of medical treatment or who have side effects affecting their quality of life. The most used device for PAE is Embosphere® (Merit Medical). It bears the European CE (Conforme aux Exigences) marking for this specific indication and approximately 500 patients have been treated with it worldwide. Nonetheless, no big randomized study has proven its efficacy compared with best medical treatment. A study comparing PAE using Embosphere® and surgery (TURP) is currently enrolling patients; no patients could be included in France because men with BPH refused to be potentially assigned the surgical arm.
To properly evaluate PAE, the investigators designed the PARTEM trial, which has received the support of both the Societe Francaise de Radiologie (French society of radiology) and of the Association Francaise d'Urologie (French association of urology).
PARTEM will compare prospectively the benefit of PAE using Embosphere® to the benefit of combined medical treatment (Combodart®: Dutasteride 0.5mg Tamsulosin 0.4mg) at 9 months with an extended follow up at 24 months in order to evaluate the stability of results in both groups.
The investigators plan a multicentre, prospective, randomized, open label, parallel trial, comparing PAE to Combined Therapy (CT: alpha-blockers + 5-ARI treatment). Treatments will be allocated by minimization with a 1:1 ratio, based on study centre, IPSS score (moderate/severe) and prostate volume (< 80 g/≥80 g).
This study is designed to demonstrate the superiority of PAE to decrease LUTS compared to best medical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Embolization | Experimental | Device: Embosphere® (Prostatic Arteries Embolization)Prostatic Arteries Embolization |
| Combined Therapy | Active comparator | Drug: Drug therapyCombodart® : dutasteride 0.5 mg/tamsulosin 0.4 mg per day |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men aged>= 50 and <=85 years AND
- Moderate to severe LUTS defined as IPSS > 11, and QoL > 3 AND
- No improvement after an alpha blocker treatment line (Tamsulosin 0.4 mg p.d. during 1 month) AND
- Prostatic volume >=50 ml AND
- Affiliated to a French health insurance system
Key exclusion criteria (21 listed)
- Severe allergy to iodine contrast agent
- Treatment with 5-ARI on the last 6 months
- Suspected prostate cancer requiring specific management
- On-going prostatitis
- On-going urinary retention
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 |
|---|---|---|
| Embosphere® (Prostatic Arteries Embolization)Prostatic Arteries Embolization with 300-500 µm trisacryl microspheres | Device | Embolization |
| Drug therapyCombodart (dutasteride 0.5 mg/tamsulosin 0.4 mg) | Drug | Combined Therapy |
Primary outcome
Change in IPSS score
Time frame: 9 months
12 secondary outcomes
Number of Adverse Events
Time frame: 3, 9, 18, 24 months
IPSS
Time frame: 3, 18, 24 months
Qmax
Time frame: 3, 9, 24 months
International Index of Erectile Function (IIEF) score
Time frame: 3, 9, 18, 24 months
prostate volume
Time frame: 3, 9, 24 months
Prostate-Specific Antigen (PSA) level
Time frame: 3, 9, 18, 24 months
Quality of life score
Time frame: 3, 9, 18, 24 months
Treatment units' account
Time frame: 3, 9 months
Adherence to treatment questionnaire
Time frame: 3, 9 months
number of PAE
Time frame: 24 months
number of surgical treatment
Time frame: 24 months
number of medication
Time frame: 3, 9, 18, 24 months
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 3 May 2022.
- Derived from this study: PubMed 37415648Sapoval M, Thiounn N, Descazeaud A, Dean C, Ruffion A, Pagnoux G, Duarte RC, Robert G, Petitpierre F, Karsenty G, Vidal V, Murez T, Vernhet-Kovacsik H, de la Taille A, Kobeiter H, Mathieu R, Heautot JF, Droupy S, Frandon J, Barry Delongchamps N, Korb-Savoldelli V, Durand-Zaleski I, Pereira H, Chatellier G; PARTEM study group. Prostatic artery embolisation versus medical treatment in patients with benign prostatic hyperplasia (PARTEM): a randomised, multicentre, open-label, phase 3, superiority trial. Lancet Reg Health Eur. 2023 Jun 26;31:100672. doi: 10.1016/j.lanepe.2023.100672. eCollection 2023 Aug.
- Individual participant dataSharing planned: Undecided
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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.
Marc Sapoval, MD principal investigator
Assistance Publique - Hôpitaux de Paris
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Embosphere® (Prostatic Arteries Embolization) and Drug therapy in people with Benign Prostatic Hyperplasia, run by Assistance Publique - Hôpitaux de Paris at 13 sites in France.
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 5 inclusion and 21 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 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change in IPSS score (time frame: 9 months). 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 NCT02869971, which also lists 1 linked publication.
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 3 May 2022.