UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030864 |
|---|---|
| Receipt number | R000035240 |
| Scientific Title | A prospective study of salvage radiotherapy combined with horrmone therapy for high-risk recurrent prostate cancer after radical prostatectomy |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2022/07/23 19:25:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A prospective study of salvage radiotherapy combined with horrmone therapy for high-risk recurrent prostate cancer after radical prostatectomy
Acronym
The SAHOP study
Scientific Title
A prospective study of salvage radiotherapy combined with horrmone therapy for high-risk recurrent prostate cancer after radical prostatectomy
Scientific Title:Acronym
The SAHOP study
Region
| Japan |
Condition
Condition
Recurrent prostate cancer after radical prostatectomy
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The evaluation of clinical efficacy of salvage radiotherapy combined with horomone therapy for reuccurent prostate cancer after radical prostatectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Second biochemical recurrence-free survival
Key secondary outcomes
1) Salvage hormone therapy-free survival
2) Metastatic-free survival
3) Cancer-specific survival
4) Overall survival
5) Adverse event
6) Body composition analysis after treatment
7) Health-related quality of life after treatment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
Salvage radiotherapy (monotherapy, 70Gy/35fr to the prostate surgical bed)
or
Salvage radiotherapy (70Gy/35fr to the prostate surgical bed) combined with hormone therapy (LHRH analogue and bicalutamide 80mg 1T per day)
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
| 85 | years-old | >= |
Gender
Male
Key inclusion criteria
1) History of radical prostatectomy for prostate cancer of clinical stage, T1-T3N0M0
2) Pathological stage, T0, T2, T3
3) Pathological stage, N0 or Nx
4) Continuous elevation of serum PSA level, which is 0.2 ng/mL or more
5) Serum PSA level, 1.0 ng/mL or less
6) No radiographcally-detected recurrent lesions
7) No history of radiotherapy to the pelvic for other malignant diseases
8) Age, 20 to 85 yo
9) ECOG-PS 0 or 2
10) No history of blood transfusion within 28 days before the registration
11) Sufficient organ functions within 28 days before the registration
12) Agreement for enrolment in the study with the signed form
Key exclusion criteria
Inappropriate for the enrolment by the judgement of the physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Makito |
| Middle name | |
| Last name | Miyake |
Organization
Nara Medical University
Division name
Department of Urology
Zip code
634-8522
Address
840 Shijo-cho, Kashihara-shi, Nara, Japan
TEL
14072667441
makitomiyake@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Makito |
| Middle name | |
| Last name | Miyake |
Organization
Nara Medical University
Division name
Department of Urology
Zip code
634-8522
Address
840 Shijo-cho, Kashihara-shi, Nara, Japan
TEL
0744-22-3051
Homepage URL
http://www.naramed-u.ac.jp/~urol/
urology@naramed-u.ac.jp
Sponsor or person
Institute
Department of Urology, Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Nara Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Urology, Nara Prefecture General Medical Center
Urology, Nara City Hospital
Urology, Takai Hospital
Urology, Yamato Takada Municipal Hospital
Urology, Hoshigaoka Medical Center
Urology, Tane General Hospital
Urology, Matsuzaka Chuo General Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute of Clinical and Translational Science, Nara Medical University
Address
840 Shijo-cho, Kashihara
Tel
0744-22-3051
f-okumura@naramed-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
奈良県立医科大学付属病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 17 | Day |
Last modified on
| 2022 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035240
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
