UMIN-CTR Clinical Trial

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
Email	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/
Email	urology@naramed-u.ac.jp

Sponsor
Institute	Department of Urology, Nara Medical University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035240