UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009876
Receipt number R000011573
Scientific Title Clinical significance of [-2]proPSA during active surveillance for localized prostate cancer
Date of disclosure of the study information 2013/01/25
Last modified on 2021/01/31 16:53:21

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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 or person

Institute

Department of Urology, Kagawa University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011573


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name