UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000033344
Receipt number R000036508
Scientific Title A clinical pilot study on the safety of highly-hypofractionated Dynamic WaveArc radiation therapy with simultaneous integrated boost for high-risk prostate cancer
Date of disclosure of the study information 2018/07/15
Last modified on 2023/01/13 17:59:44

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Basic information

Public title

A clinical pilot study on the safety of highly-hypofractionated Dynamic WaveArc radiation therapy with simultaneous integrated boost for high-risk prostate cancer

Acronym

highly-hypofractionated DWA radiation therapy for high-risk prostate cancer

Scientific Title

A clinical pilot study on the safety of highly-hypofractionated Dynamic WaveArc radiation therapy with simultaneous integrated boost for high-risk prostate cancer

Scientific Title:Acronym

highly-hypofractionated DWA radiation therapy for high-risk prostate cancer

Region

Japan


Condition

Condition

prostate cancer

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety of highly-hypofractionated Dynamic WaveArc radiation therapy (57 Gy/54 Gy/15 fractions/3 weeks) with simultaneous integrated boost for patients with high-risk prostate cancer.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Incidences of acute adverse events

Key secondary outcomes

Incidences of late adverse events at 2 years
PSA recurrence-free suravival rate at 2 years


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

Maneuver

Interventions/Control_1

Highly-hypofractionated Dynamic WaveArc radiation therapy with simultaneous integrated boost (57 Gy/54 Gy/15 fractions/3 weeks) is applied after 6 to 12 months neoadjuvant hormonal therapy.

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

50 years-old <=

Age-upper limit

85 years-old >=

Gender

Male

Key inclusion criteria

1) Histologically confirmed as adenocarcinoma of the prostate.
2) Prostate cancer cases and diagnosed as cT2a-T3a and classified to high-risk based on MRI, CT and bone scintigraphy before the initiation of neoadjuvant hormonal therapy.
3) Neoadjuvant hormonal therapy is performed.
4) Age at the registration is >=50 and <80 years old.
5) Performance status is 0 or 1 with Eastern Cooperative Oncology Group definition.
6) Cases submitted a written informed consent.
7) The basic blood examinations, including serum prostate-specific antigen (PSA) level was performed before the initiation of neoadjuvant hormonal therapy.

Key exclusion criteria

1) cT3a, iPSA >=30 ng/ml, and GS >= 4+4
2) active double cancer (i.e., overlapping cancer or asynchronous cancer within 5 years, except carcinoma in situ, intramucosal cancer, and other equivalent lesions)
3) Uncontrolled diabetes mellitus (HbA1c>+8.4%)
4) Severe coexisting diseases such as collagen disease, heart disease, respiratory disease and liver disease.
5) Psychotic disease
6) History of pelvic irradiation
7) History of pelvic surgery except for appendectomy and femoral herniation.
8) Surgical managements to the prostate
9) Chemotherapy to the prostate cancer
10) Inflammatory bowel diseases
11) Cases who are difficult to discontinue the administration of anticoagulant drugs.
12) Cases who are considered difficult to achieve dose constrain because of risk organs.
13) Cases with diffuse or large prostatic lesions.
14) Cases with significant metal artifact on pelvic CT images.
15) Cases who are difficult to achieve dose constrain at treatment planning.

Target sample size

25


Research contact person

Name of lead principal investigator

1st name Takashi
Middle name
Last name Mizowaki

Organization

Kyoto University Graduate School of Medicine

Division name

Department of Radiation Oncology and Image-applied Therapy

Zip code

6608507

Address

54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto

TEL

075-751-3762

Email

mizo@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name Takashi
Middle name
Last name Mizowaki

Organization

Kyoto University Graduate School of Medicine

Division name

Department of Radiation Oncology and Image-applied Therapy

Zip code

6608507

Address

54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto

TEL

075-751-3762

Homepage URL


Email

mizo@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Department of Radiation Oncology & Image-applied Therapy, Kyoto University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyoto University Graduate School and Fakulty of Medicine

Address

Yoshida-Konoe-cho, Sakyo-ku, Kyoto, Japan

Tel

075-753-4680

Email

ethcom@kuhp.kyoto-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

京都大学医学部附属病院(京都府)


Other administrative information

Date of disclosure of the study information

2018 Year 07 Month 15 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

26

Results

The incidents of acute adverse events of grade 2 or higher, the primary endpoints, were 26,9% and 7.7% for the urinary and rectum, respectively. No event of grade 3 or higher toxicity was observed.

Results date posted

2023 Year 01 Month 13 Day

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

2018 Year 07 Month 09 Day

Date of IRB

2018 Year 07 Month 12 Day

Anticipated trial start date

2018 Year 07 Month 15 Day

Last follow-up date

2023 Year 01 Month 15 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 07 Month 10 Day

Last modified on

2023 Year 01 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036508


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name