Bladder CancerPhase 4NCT02443844
Comparison of Medical and Surgical Treatments of Benign Prostate Hyperplasia in Patients Who Have Low Grade Non Muscle Invasive Bladder Cancer for Tumour Recurrence and Progression
A Phase 4 study testing Transurethral Resection and Tamsulosin in people with Bladder Cancer, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to compare medical and surgical treatments of benign prostate hyperplasia in patients who have non muscle invasive bladder cancer for tumour recurrence and progression. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Transurethral Resection and Tamsulosin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2015to Feb 2020
- 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 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have non muscle invasive bladder cancer male patients patients between 40-80 years old
Who cannot join
- Patients who have previous prostate surgery Patients who have muscle invasive bladder cancer
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Turkish Ministry of Health Dıskapı Yıldırım Beyazıt Training and Research Hospital
Ankara, 06110
Nihat Karakoyunlu, MD, 00905324747134, nkarakoyunlu@gmail.com
Nihat Karakoyunlu, MD
About this study
The purpose of this study is to compare medical and surgical treatments of benign prostate hyperplasia in patients who have non muscle invasive bladder cancer for tumour recurrence and progression.
- Conditions
- Bladder Cancer
- Being tested
- Transurethral Resection, Tamsulosin
- Keywords
- BPH, bladder cancer, treatment, recurrence, progression
- Medical subject headings
- Urinary Bladder Neoplasms, Recurrence, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transurethral ResectionProcedure or surgery
Endoscopic treatment of bladder cancer
TamsulosinDrug
Also called alfa blocker treatment
Medical treatment for benign prostate hyperplasia
| Study group | Role | What they receive |
|---|---|---|
| First group | Active comparator | Patients taken tamsulosin for benign prostate hyperplasia who have non muscle invasive bladder cancer Receives: Drug: Tamsulosin |
| Second Group | Active comparator | Patients taken transurethral resection prostatectomy for benign prostate hyperplasia who have non muscle invasive bladder cancer Receives: Procedure: Transurethral Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
Bladder cancer recurrence rate
Measured: 3 years
Secondary outcomes (1)
Progression
Bladder cancer progression rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2020 (estimated)
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 Bladder CancerStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nihat Karakoyunlu, Diskapi Teaching and Research Hospital
- Investigators
- Nihat Karakoyunlu, MD, Principal investigator, Dıskapı TRH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02443844
- Sponsor's protocol ID
- 16.02.2015 20/03
- Status last verified
- May 2015
- First submitted
- 28 Apr 2015
- Last updated
- 14 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Li S, Zeng XT, Ruan XL, Wang XH, Guo Y, Yang ZH. Simultaneous transurethral resection of bladder cancer and prostate may reduce recurrence rates: A systematic review and meta-analysis. Exp Ther Med. 2012 Oct;4(4):685-692. doi: 10.3892/etm.2012.660. Epub 2012 Aug 9.
PubMed 23170127
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Medical and Surgical Treatments of Benign Prostate Hyperplasia in Patients Who Have Low Grade Non Muscle Invasive Bladder Cancer for Tumour Recurrence and Progression
- ClinicalTrials.gov ID
- NCT02443844
- Acronym / sponsor ID
- 16.02.2015 20/03
- Conditions
- Bladder Cancer
- Keywords
- BPH, bladder cancer, treatment, recurrence, progression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 14 May 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.
The purpose of this study is to compare medical and surgical treatments of benign prostate hyperplasia in patients who have non muscle invasive bladder cancer for tumour recurrence and progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First group | Active comparator | Drug: TamsulosinPatients taken tamsulosin for benign prostate hyperplasia who have non muscle invasive bladder cancer |
| Second Group | Active comparator | Procedure: Transurethral ResectionPatients taken transurethral resection prostatectomy for benign prostate hyperplasia who have non muscle invasive bladder cancer |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have non muscle invasive bladder cancer male patients patients between 40-80 years old
Key exclusion criteria (1 listed)
- Patients who have previous prostate surgery Patients who have muscle invasive bladder cancer
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 |
|---|---|---|
| Transurethral ResectionEndoscopic treatment of bladder cancer | Procedure or surgery | Second Group |
| TamsulosinAlso: alfa blocker treatmentMedical treatment for benign prostate hyperplasia | Drug | First group |
Primary outcome
Recurrence
Time frame: 3 years
Bladder cancer recurrence rate
1 secondary outcome
Progression
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2015.
- Results publication: PubMed 23170127Li S, Zeng XT, Ruan XL, Wang XH, Guo Y, Yang ZH. Simultaneous transurethral resection of bladder cancer and prostate may reduce recurrence rates: A systematic review and meta-analysis. Exp Ther Med. 2012 Oct;4(4):685-692. doi: 10.3892/etm.2012.660. Epub 2012 Aug 9.
Related trials for Bladder Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
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.
Nihat Karakoyunlu, MD principal investigator
Dıskapı TRH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Transurethral Resection and Tamsulosin in people with Bladder Cancer, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 May 2015. 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 Turkey (Türkiye). 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nihat Karakoyunlu, MD (00905324747134, nkarakoyunlu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence (time frame: 3 years). 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 NCT02443844, 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 14 May 2015.