UMIN-CTR Clinical Trial

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
Email	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
Email	shingorilla2@gmail.com

Sponsor
Institute	Hirosaki University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023857