UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020674 |
|---|---|
| Receipt number | R000023857 |
| Scientific Title | A Randomized, Open-Label, Multicenter study to evaluate effect of tadalafil on lower urinary tract symptoms in patients with prostate cancer treated after radiotherapy (T-addon-RT trial) |
| Date of disclosure of the study information | 2016/01/21 |
| Last modified on | 2022/07/27 10:06:14 |
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Basic information
Public title
A Randomized, Open-Label, Multicenter study to evaluate effect of tadalafil on lower urinary tract symptoms in patients with prostate cancer treated after radiotherapy (T-addon-RT trial)
Acronym
A Randomize study to evaluate effect of tadalafil on lower urinary tract symptoms in patients with prostate cancer treated after radiotherapy
Scientific Title
A Randomized, Open-Label, Multicenter study to evaluate effect of tadalafil on lower urinary tract symptoms in patients with prostate cancer treated after radiotherapy (T-addon-RT trial)
Scientific Title:Acronym
A Randomize study to evaluate effect of tadalafil on lower urinary tract symptoms in patients with prostate cancer treated after radiotherapy
Region
| Japan |
Condition
Condition
Prostate cancer treated after radiotherapy
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This is a randomized, open-label, multinational, 12-week study to evaluating efficacy of tadalafil tadalafil on lower urinary tract symptoms in patients with prostate cancer treated after radiotherapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change from Baseline to 12 Week of International Prostate Symptom Score (IPSS)
Key secondary outcomes
Change from Baseline to 12 Week of
IPSS Irritative Subscore
IPSS Voiding (Obstructive) Subscore
IPSS Quality of Life (QoL) Index
Uroflowmetry Parameter: Peak Flow Rate (Qmax)
Number of Participants with Adverse Events International Index of Erectile Function (IIEF)
Blood Pressure
Postvoid Residual Volume (PVR)
Prostate Specific Antigen (PSA)
Testosterone
oxygen stress
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tadalafil 5mg one a day, for 12 weeks
Interventions/Control_2
Observation for 12 weeks, continuation of concomitant argents
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 99 | years-old | > |
Gender
Male
Key inclusion criteria
Males, 20 years or older, in patients with prostate cancer treated after radiotherapy;, including lower urinary tract symptoms (IPSS>7, or nocturia >1) who were not taking tadalafil
Agree not to change prostate cancer or use erectile dysfunction treatments anytime during the study
Have not taken phosphodiesterase type 5 (PDE5) inhibitors for specified duration of time prior to Visit 1.
Without biochemical recurrence (prostate specific antigen < 2.0) at the visit 1.
Key exclusion criteria
Prostate specific antigen (PSA) beyond 2.0 ng/mL defined for study at Visit 1.
History of urinary retention or lower urinary tract (bladder) stones within 6 months of Visit 1.
History of urethral obstruction due to stricture, valves, sclerosis, or tumor at Visit 1.
Clinical evidence of recurrent prostate cancer at Visit 1.
Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at Visit 1.
History of cardiac conditions, including angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study.
History of significant central nervous system (CNS) injuries (including stroke or spinal cord injury) within 6 months of Visit 1.
Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH) agonists/antagonists, or anabolic steroids at Visit 1.
History of drug, alcohol, or substance abuse within the 6 months before Visit 1.
Have any condition, limitation, or disease that could, in the judgment of the investigator, preclude evaluation of response to tadalafil
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Chikara |
| Middle name | |
| Last name | Ohyama |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Urology
Zip code
036-8562
Address
5 Zaifu-chou, Hirosaki, Japan
TEL
+81172395091
coyama@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Hatakeyama |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Urology
Zip code
036-8562
Address
5 Zaifu-chou, Hirosaki, Japan
TEL
+81172395091
Homepage URL
shingorilla2@gmail.com
Sponsor or person
Institute
Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Oyokyo Kidney Research Institute
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hirosaki Universicy IRB
Address
5 Zaifu-chou
Tel
0172395091
rinri@hirosaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 07 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 07 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 07 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 21 | Day |
Last modified on
| 2022 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023857
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