UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003992 |
|---|---|
| Receipt number | 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 | 2023/01/16 13:14:27 |
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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
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
trip@bz03.plala.or.jp
Sponsor or person
Institute
Kanazawa University
Translational Research Informatices Center
Institute
Department
Personal name
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
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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2010 | Year | 09 | Month | 01 | Day |
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
| 2023 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004807
