UMIN-CTR Clinical Trial

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

prostate cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Urology, Kagawa University

Institute

Department

Personal name

Organization

MEXT

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Kagawa University

Address

1750-1 Ikenobe Miki-cho Kita-gun Kagawa

Tel

0878985111

Email

micsugi@med.kagawa-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

香川大学医学部附属病院（香川県）

Date of disclosure of the study information

2013

Year

01

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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