Prostate HyperplasiaEarly Phase 1NCT04848181
The Effect of Pre-operative Use of Finasteride Versus Cyproterone Acetate on Blood Loss With Transurethral Resection of Prostate
A Early Phase 1 study testing cyproterone acetate, finasteride and no treatment received in people with Prostate Hyperplasia, run by Benha University at 1 site in Egypt.
Trial summary
Perioperative bleeding is the most common complication related to transurethral resection of prostate, the aim of the study is to compare the effect of pre-operative use of finasteride versus Cyproterone acetate on blood loss with mono polar TURP Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Hyperplasia
- What is being tested?
- cyproterone acetate, finasteride and no treatment received
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2019to 9 Jul 2020
- Phase
- Early Phase 1
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with benign prostatic hyperplasia with prostate size (60-100) grams
- Lower urinary tract symptoms (LUTS) not responding to medical treatment
- Recurrent prostatic bleeding
- Recurrent acute urinary retention
- Chronic urinary retention
Who cannot join
- Patients with coagulation disorders
- Previous prostatic surgery
- Previous finasteride administration
- Bladder pathology (urinary bladder stones - bladder mass)
- Suspected or proved cancer prostate
- Hepatic or renal impairment
- Patients unfit for operation eg. Decompensated heart failure, poor chest condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Short Term Use of Finasteride Versus Cyproterone Acetate on Perioperative Blood Loss With Mono Polar Transurethral Resection of Prostate
Perioperative bleeding is the most common complication related to transurethral resection of prostate, the aim of the study is to compare the effect of pre-operative use of finasteride versus Cyproterone acetate on blood loss with mono polar TURP
Read the detailed description
This prospective randomized controlled study to compare the effect of pre-operative use of finasteride versus Cyproterone acetate on blood loss with mono polar TURP
- Conditions
- Prostate Hyperplasia
- Being tested
- cyproterone acetate, finasteride, no treatment received
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyproterone acetateDrug
two weeks Cyproterone acetate administration before TURP
finasterideDrug
two weeks finasteride administration before TURP
no treatment receivedDrug
no treatment received before TURP
| Study group | Role | What they receive |
|---|---|---|
| cyproterone acetate | Active comparator | 20 patients received cyproterone acetate 50 mg twice per day for two weeks before TURP Receives: Drug: cyproterone acetate |
| finasteride group | Active comparator | 20 patients received finasteride 5 mg once per day for two weeks before TURP Receives: Drug: finasteride |
| control group | Placebo comparator | 20 patients received no treatment before TURP Receives: Drug: no treatment received |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative Hb
measuring serum haemoglobin level at first post operative
Measured: 24 hour post operative
post operative Hcv
measuring serum haematocrit value at first post operative
Measured: 24 hour post operative
operative duration
assessment of the duration of the operation
Measured: immediately after surgery
microvascular density(MVD)
assesment of MVD of the prostate by histological examination using high power field microscope
Measured: 2 weeks after drug intake
intraoperative blood loss
assessment of intraoperative blood loss during TURP
Measured: immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start1 Jul 2019
- Primary completion1 Jul 2020
- Study completion9 Jul 2020
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 Prostate HyperplasiaStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shabieb Ahmed, Benha University
- Investigators
- shabieb ahmed, Ph.D, Study director, Benha Universityabdallah fathy, Ph.D, Study director, Benha Universitymohamed hefnawy, Ph.D, Study chair, Benha Universityadel al falah, Ph.D, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04848181
- Sponsor's protocol ID
- benign prostatic hyperplasia
- Status last verified
- Jul 2021
- First submitted
- 9 Apr 2021
- Last updated
- 21 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Treharne C, Crowe L, Booth D, Ihara Z. Economic Value of the Transurethral Resection in Saline System for Treatment of Benign Prostatic Hyperplasia in England and Wales: Systematic Review, Meta-analysis, and Cost-Consequence Model. Eur Urol Focus. 2018 Mar;4(2):270-279. doi: 10.1016/j.euf.2016.03.002. Epub 2016 Mar 23.
PubMed 28753756Yang TY, Chen M, Lin WR, Li CY, Tsai WK, Chiu AW, Ko MC. Preoperative treatment with 5alpha-reductase inhibitors and the risk of hemorrhagic events in patients undergoing transurethral resection of the prostate - A population-based cohort study. Clinics (Sao Paulo). 2018 Mar 12;73:e264. doi: 10.6061/clinics/2018/e264.
PubMed 29538495Khwaja MA, Nawaz G, Muhammad S, Jamil MI, Faisal M, Akhter S. The Effect of Two Weeks Preoperative Finasteride Therapy in Reducing Prostate Vascularity. J Coll Physicians Surg Pak. 2016 Mar;26(3):213-5.
PubMed 26975954Tian HL, Zhao CX, Wu HY, Xu ZX, Wei LS, Zhao RT, Jin DL. Finasteride reduces microvessel density and expression of vascular endothelial growth factor in renal tissue of diabetic rats. Am J Med Sci. 2015 Jun;349(6):516-20. doi: 10.1097/MAJ.0000000000000451.
PubMed 25789687
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Short Term Use of Finasteride Versus Cyproterone Acetate on Perioperative Blood Loss With Mono Polar Transurethral Resection of Prostate
- ClinicalTrials.gov ID
- NCT04848181
- Acronym / sponsor ID
- benign prostatic hyperplasia
- Conditions
- Prostate Hyperplasia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 9 Jul 2020 (actual)
- First posted
- 19 Apr 2021 (actual)
- 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.
Perioperative bleeding is the most common complication related to transurethral resection of prostate, the aim of the study is to compare the effect of pre-operative use of finasteride versus Cyproterone acetate on blood loss with mono polar TURP
Detailed description
This prospective randomized controlled study to compare the effect of pre-operative use of finasteride versus Cyproterone acetate on blood loss with mono polar TURP
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cyproterone acetate | Active comparator | Drug: cyproterone acetate20 patients received cyproterone acetate 50 mg twice per day for two weeks before TURP |
| finasteride group | Active comparator | Drug: finasteride20 patients received finasteride 5 mg once per day for two weeks before TURP |
| control group | Placebo comparator | Drug: no treatment received20 patients received no treatment before TURP |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with benign prostatic hyperplasia with prostate size (60-100) grams
- Lower urinary tract symptoms (LUTS) not responding to medical treatment
- Recurrent prostatic bleeding
- Recurrent acute urinary retention
- Chronic urinary retention
Key exclusion criteria (7 listed)
- Patients with coagulation disorders
- Previous prostatic surgery
- Previous finasteride administration
- Bladder pathology (urinary bladder stones - bladder mass)
- Suspected or proved cancer prostate
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 |
|---|---|---|
| cyproterone acetatetwo weeks Cyproterone acetate administration before TURP | Drug | cyproterone acetate |
| finasteridetwo weeks finasteride administration before TURP | Drug | finasteride group |
| no treatment receivedno treatment received before TURP | Drug | control group |
Primary outcome
post operative Hb
Time frame: 24 hour post operative
measuring serum haemoglobin level at first post operative
post operative Hcv
Time frame: 24 hour post operative
measuring serum haematocrit value at first post operative
operative duration
Time frame: immediately after surgery
assessment of the duration of the operation
microvascular density(MVD)
Time frame: 2 weeks after drug intake
assesment of MVD of the prostate by histological examination using high power field microscope
intraoperative blood loss
Time frame: immediately after surgery
assessment of intraoperative blood loss during TURP
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 21 Jul 2021.
- Background: PubMed 28753756Treharne C, Crowe L, Booth D, Ihara Z. Economic Value of the Transurethral Resection in Saline System for Treatment of Benign Prostatic Hyperplasia in England and Wales: Systematic Review, Meta-analysis, and Cost-Consequence Model. Eur Urol Focus. 2018 Mar;4(2):270-279. doi: 10.1016/j.euf.2016.03.002. Epub 2016 Mar 23.
- Background: PubMed 29538495Yang TY, Chen M, Lin WR, Li CY, Tsai WK, Chiu AW, Ko MC. Preoperative treatment with 5alpha-reductase inhibitors and the risk of hemorrhagic events in patients undergoing transurethral resection of the prostate - A population-based cohort study. Clinics (Sao Paulo). 2018 Mar 12;73:e264. doi: 10.6061/clinics/2018/e264.
- Background: PubMed 26975954Khwaja MA, Nawaz G, Muhammad S, Jamil MI, Faisal M, Akhter S. The Effect of Two Weeks Preoperative Finasteride Therapy in Reducing Prostate Vascularity. J Coll Physicians Surg Pak. 2016 Mar;26(3):213-5.
- Background: PubMed 25789687Tian HL, Zhao CX, Wu HY, Xu ZX, Wei LS, Zhao RT, Jin DL. Finasteride reduces microvessel density and expression of vascular endothelial growth factor in renal tissue of diabetic rats. Am J Med Sci. 2015 Jun;349(6):516-20. doi: 10.1097/MAJ.0000000000000451.
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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.
shabieb ahmed, Ph.D study director
Benha University
abdallah fathy, Ph.D study director
Benha University
mohamed hefnawy, Ph.D study chair
Benha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing cyproterone acetate, finasteride and no treatment received in people with Prostate Hyperplasia, run by Benha University at 1 site in Egypt.
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 7 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 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
post operative Hb (time frame: 24 hour post operative). The study lists 5 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 NCT04848181, 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 21 Jul 2021.