UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013514
Receipt number R000015754
Scientific Title The evaluation of the efficacy of a switch from GnRH agonist to GnRH antagonist in prostate cancer patients who relapsed during combined androgen blockade.
Date of disclosure of the study information 2014/03/27
Last modified on 2014/09/05 07:38:46

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Basic information

Public title

The evaluation of the efficacy of a switch from GnRH agonist to GnRH antagonist in prostate cancer patients who relapsed during combined androgen blockade.

Acronym

The evaluation of the efficacy of a switch from GnRH agonist to GnRH antagonist in prostate cancer patients who relapsed during combined androgen blockade.

Scientific Title

The evaluation of the efficacy of a switch from GnRH agonist to GnRH antagonist in prostate cancer patients who relapsed during combined androgen blockade.

Scientific Title:Acronym

The evaluation of the efficacy of a switch from GnRH agonist to GnRH antagonist in prostate cancer patients who relapsed during combined androgen blockade.

Region

Japan


Condition

Condition

prostate cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of a switch from GnRH agonist to GnRH antagonist in prostate cancer patients who relapsed during combined androgen blockade.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

the percentage of patients showing decreasing or stable PSA (relative change from baseline of less than 10%) after 12 weeks of GnRH antagonist treatment

Key secondary outcomes

1. the percent change of PSA from baseline at 12 weeks and the maximal change at any time
2. PSA progression-free survival (PSA PFS) (PSA progression was defined as an increase in PSA of >=25% and >=2ng/ml above the nadir.)
3. radiographic progression-free survival (radiographic PFS) (progression in soft-tissue lesions was defined using RECIST criteria, and progression in bone was defined as the appearance of a minimum of two new lesions on bone scan.)
4. overall survival
5. changes in testosterone, LH, FSH, TRACP-5b and ICTP levels
6. safety (adverse events)
7. QOL (FACT-P)


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

Medicine

Interventions/Control_1

Patients are switched from GnRH agonist to GnRH antagonist degarelix. Degarelix is administered subcutaneously at an initial dose of 240mg followed by maintenance doses of 80mg every 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male

Key inclusion criteria

1. histologically confirmed adenocarcinoma of the prostate
2. receiving combined androgen blockade with GnRH agonist and a non-steroidal antiandrogen (bicalutamide or flutamide)
3. two consecutive increases in PSA at a minimum of 1-week intervals and PSA value >= 2.0ng/ml
4. castrate testosterone levels (<=0.5ng/ml)
5. ECOG performance status 0-1
6. laboratory requirements
Hb >= 8.0g/dl
WBC >= 3,000/mm3
platelet >= 100,000/mm3
both AST and ALT <= 2.5 x upper limit of normal
serum creatinine <= 2.0 x upper limit of normal
7. Signed informed consent is obtained prior to the entry to this clinical study.

Key exclusion criteria

1. receiving chemotherapeutic agents (including estramustine), corticosteroids, hormone agents except for GnRH agonist and non-steroidal antiandrogens, or investigational drugs
2. patients who never responded to CAB
3. patients with active multiple cancers
4. patients with clinical symptoms such as bone pain and nerve injury as a result of a spinal cord compression
5. prior treatment with local therapy (radical prostatectomy or radiotherapy)
6. patients with severe hepatic dysfunction (Child-Pugh class C)
7. patients with HIV or chronic active hepatitis B/C
8. history of acute myocardial infarction, severe or unstable angina, coronary or peripheral arterial revascularization, symptomatic congestive heart failure, cerebral vascular disease, transient ischemic attacks, or pulmonary embolism within 6 months before registration
9. patients with interstitial pneumonia or past history of interstitial pneumonia
10. patients with a brain tumor

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroki Hirabayashi

Organization

Komaki City Hospital

Division name

Urology

Zip code


Address

1-20, Jobushi, Komaki, Aichi 485-8520, JAPAN

TEL

0568-76-4131

Email

hirabayashi-umin@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroki Hirabayashi

Organization

Komaki City Hospital

Division name

Urology

Zip code


Address

1-20, Jobushi, Komaki, Aichi 485-8520, JAPAN

TEL

0568-76-4131

Homepage URL


Email

hirabayashi-umin@umin.ac.jp


Sponsor or person

Institute

Tokai Urological Clinical Trial Group

Institute

Department

Personal name



Funding Source

Organization

Tokai Urological Clinical Trial Group

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Nagoya University
National Hospital Organization Nagoya Medical Center
Social Insurance Chukyo Hospital
Okazaki City Hospital
Chubu Rosai Hospital
Japanese Red Cross Nagoya Daiichi Hospital
Japanese Red Cross Nagoya Daini Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

小牧市民病院(愛知県)、名古屋大学医学部(愛知県)、国立病院機構名古屋医療センター(愛知県)、社会保険中京病院(愛知県)、岡崎市民病院(愛知県)、中部労災病院(愛知県)、名古屋第一赤十字病院(愛知県)、名古屋第二赤十字病院(愛知県)


Other administrative information

Date of disclosure of the study information

2014 Year 03 Month 27 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

2014 Year 03 Month 06 Day

Date of IRB


Anticipated trial start date

2014 Year 05 Month 09 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 03 Month 25 Day

Last modified on

2014 Year 09 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015754


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name