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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003992
Receipt No. R000004807
Scientific Title RCT of Tri-Modalities with I-125 Brachy Therapy and EBRT and Short or Long Term Hormone Therapy for High-risk Localized Prostate Cancer
Date of disclosure of the study information 2010/08/05
Last modified on 2014/08/04

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Basic information
Public title RCT of Tri-Modalities with I-125 Brachy Therapy and EBRT and Short or Long Term Hormone Therapy for High-risk Localized Prostate Cancer
Acronym RCT of Tri-Modalities with I-125 Brachy Therapy and EBRT and Short or Long Term Hormone Therapy for High-risk Localized Prostate Cancer (TRIP Study)
Scientific Title RCT of Tri-Modalities with I-125 Brachy Therapy and EBRT and Short or Long Term Hormone Therapy for High-risk Localized Prostate Cancer
Scientific Title:Acronym RCT of Tri-Modalities with I-125 Brachy Therapy and EBRT and Short or Long Term Hormone Therapy for High-risk Localized Prostate Cancer (TRIP Study)
Region
Japan

Condition
Condition Prostate Cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of long term hormonal therapy (HT) vs. short term HT in the setting of Tri-Modality where neo-adjuvant therapy with combined androgen blockade (CAB), brachytherapy with I-125 and external beam radio-therapy (hereafter brachytherapy and EBRT) were applied and then followed by LH-RH analog as adjuvant therapy (AHT) for high risk patients with prostate cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Biochemical progression free survival (PSA progression free survival)
Key secondary outcomes 1. Overall survival
2. Clinical progression free survival
3. Cause specific survival
4. Time to salvage therapy
5. QOL
6. Adverse Events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 After treated by CAB for 3 months, Brachytherapy and EBRT to be applied. During this treatment, CAB is continued. After that, adjuvant long term hormonal therapy (24 months) to be applied.
Interventions/Control_2 After treated by CAB for 3 months, Brachytherapy and EBRT to be applied. During this treatment, CAB is continued. After that, no adjuvant hormonal therapy to be applied.
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
40 years-old <=
Age-upper limit
80 years-old >
Gender Male
Key inclusion criteria 1) Patients with high risk prostate cancer which is defined by PSA value, clinical stage or Gleason score determined by the central pathological judgment.
High risk is the case where at least one of the following three factors is satisfied
(1) PAS>20 ng/mL prior to CAB
(2) Clinical stage of T2c or T3a
(3) GS>=8 by central pathologists
2) Performance status 0-1 (ECOG)
3) Age>=40 and <80 when obtaining the written informed consent
4) Patients who satisfy the following (within 14 days prior to the CAB)
a) Peripheral blood test : WBC>=3.0x103/microL, hemoglobin>=10.0 g/dL, blood plate>=10x104/microL
b) Biological test: serum creatinine<=2.0 mg/dL, AST(GOT)<=100 IU/L, ALT(GPT)<=100 IU/L
5) Written informed consent must be obtained from patient
Key exclusion criteria 1) Patients who have active double cancer
2) Patients with poorly controlled hypertension (i.e., diastolic blood pressure>=120 mm Hg)
3) Patients with severe psychiatric disorders
4) Patients with collagen diseases
5) Patients with poorly controlled diabetes
6) Patients with poorly controlled ischemic cardiac disease
7) Patients who had prior surgery for prostate (transurethral prostatectomy, radical prostatectomy, orchiectomy, other surgery for BPH and/or hyperthermia)
8) Patients who had brachytherapy and/or EBRT
9) Patients who are taking steroid drugs (except for ointment)
10) Patients who are taking other antiandrogen for BPH
11) Patients who had CAB for more than 3 months prior to the registration
12) Patients who are judged inappropriate for the clinical trial by doctors
Target sample size 340

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mikio NAMIKI
Organization Kanazawa University Hospital
Division name Urology
Zip code
Address Takara-machi 13-1, Kanazawa, Ishikawa
TEL 076-265-2393
Email h-konaka@med.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriko MOMMA
Organization National Hospital Organization Tokyo Medical Center National Institute of Sensory Organs
Division name TRIP secretariat
Zip code
Address Higashiga Oka 2-5-1, Meguro, Tokyo
TEL 03-3422-1172
Homepage URL
Email trip@bz03.plala.or.jp

Sponsor
Institute Kanazawa University
Translational Research Informatices Center
Institute
Department

Funding Source
Organization Translational Research Informatices Center
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor Jikei University School of Medicine
National Hospital Organization Tokyo Medical Center
Name of secondary funder(s) none

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 金沢大学附属病院(石川県)
東京慈恵会医科大学(東京都)
独立行政法人 国立病院機構 東京医療センター(東京都)

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 05 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
2010 Year 07 Month 14 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 Day
Last follow-up date
2019 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 08 Month 04 Day
Last modified on
2014 Year 08 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004807

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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