UMIN-CTR Clinical Trial

Basic information
Public title	Clinical significance of [-2]proPSA during active surveillance for localized prostate cancer
Acronym	[-2]proPSA during active surveillance for prostate cancer
Scientific Title	Clinical significance of [-2]proPSA during active surveillance for localized prostate cancer
Scientific Title:Acronym	[-2]proPSA during active surveillance for prostate cancer
Region	Japan

Condition
Condition	prostate cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the clinical significance of [-2]proPSA during active surveillance for localized prostate cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	reclassification at repeat biopsy
Key secondary outcomes	1)reclassification at secondary radical prostatectomy specimen 2)active surveillance remaining rate 3)clinical progression 4)distant metastasis 5)overall survival

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	periodical prostate biopsy
Interventions/Control_2
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	50 years-old <=
Age-upper limit	80 years-old >=
Gender	Male
Key inclusion criteria	1) Histologically proven adenocarcinoma of the prostate. 2) Men should be fit for curative treatment. 3) PSA level at diagnosis 10 ng/mL or less, or 20 ng/mL or less if MRI is used at diagnosis or during follow up. 4) PSA density (PSA D) less than 0.2, or if MRI is used and negative or if targeted biopsies show no more than Gleason score 3+3 or 3+4 without invasive cribriform and intraductal carcinoma (CR/IDC) PSA D of less than 0.25 is acceptable. Patients with a PSA D or higher 0.25 at inclusion can be followed outside the actual PRIAS protocol. 5) Clinical stage T1C or T2. 6) Gleason score 3+3=6 or Gleason score 3+4 without invasive CR/IDC. Total number of positive cores allowed: a. If an MRI, including targeted biopsies on positive lesions, is done at inclusion, there is no limit in the number of positive cores (that is, more than two, and no limit in the % of cancer present in the cores). b. If saturation biopsies (either transperineal or transrectal) are done 15% of the cores can be positive with a maximum of 4. (i.e. less than 20 cores 2 cores can be positive (standard), 20-26 cores 3 cores can be positive, more than 26 cores 4 cores can be positive) (all other inclusion criteria still apply). c. If more than 2 TRUS-guided biopsy cores are positive (Gleason score 3+3 or 3+4 without CR/IDC) an MRI is indicated. If the MRI is negative or if targeted biopsies show no more than Gleason score 3+3=6 or 3+4=7 without invasive CR/IDC, inclusion is possible. d. For patients with adenocarcinoma Gleason score 3+4 without invasive CR/IDC, the maximum number of positive cores should be 50% or less, where multiple positive cores from the same lesion on MRI count for one positive core. 7) Participants must be willing to attend the follow-up visits. 8) Signed informed consent.
Key exclusion criteria	1) Men who can not or do not want to be radiated or operated. 2) A former therapy for prostate cancer. 3) For patients with a life expectancy of <10yr, watchful waiting is preferred above Active Surveillance.
Target sample size	1100

Research contact person
Name of lead principal investigator	1st name Mikio Middle name Last name Sugimoto
Organization	Kagawa University
Division name	Urology
Zip code	7610793
Address	1750-1 Ikenobe Miki-cho Kita-gun Kagawa
TEL	087-891-2202
Email	kakehi@med.kagawa-u.ac.jp

Public contact
Name of contact person	1st name Takuma Middle name Last name Kato
Organization	Kagawa University
Division name	Urology
Zip code	7610793
Address	1750-1 Ikenobe Miki-cho Kita-gun Kagawa
TEL	087-891-2202
Homepage URL
Email	micsugi@med.kagawa-u.ac.jp

Sponsor
Institute	Department of Urology, Kagawa University
Institute
Department

Funding Source
Organization	MEXT
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kagawa University
Address	1750-1 Ikenobe Miki-cho Kita-gun Kagawa
Tel	0878985111
Email	micsugi@med.kagawa-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	香川大学医学部附属病院（香川県）

Other administrative information
Date of disclosure of the study information	2013 Year 01 Month 25 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	Open public recruiting
Date of protocol fixation	2013 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date	2013 Year 01 Month 16 Day
Last follow-up date	2018 Year 01 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 01 Month 25 Day
Last modified on	2021 Year 01 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011573