UMIN-CTR Clinical Trial

Public title

Phase II study of hypofractionated postoperative intensity-modulated radiotherapy for prostate cancer in adjuvant and salvage settings

Acronym

Phase II study of hypofractionated postoperative intensity-modulated radiotherapy for prostate cancer in adjuvant and salvage settings

Scientific Title

Phase II study of hypofractionated postoperative intensity-modulated radiotherapy for prostate cancer in adjuvant and salvage settings

Scientific Title:Acronym

Phase II study of hypofractionated postoperative intensity-modulated radiotherapy for prostate cancer in adjuvant and salvage settings

Region

Japan

Condition

Prostate cancer

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The purpose of this study is to assess the toxicity and the efficacy of hypofractionated postoperative radiotherapy for prostate cancer in adjuvant and salvage settings.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

The incidence of CTCAE grade 2-4 genitourinary and gastrointestinal toxicity during the initiation of radiotherapy and 90 days from the end of radiotherapy.
Toxicities will be graded using CTCAE version 5.0.

Biochemical recurrence-free survival

Key secondary outcomes

Overall survival
The incidence of toxicity during the initiation of radiotherapy and 90 days from the end of radiotherapy
The incidence of toxicity during the follow-up period after 90 days from the end of radiotherapy
Quality of life during the all follow-up period.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Intensity modulated radiation therapy to the prostate bed will be conducted once a day. Prescribed dose will be 54 Gy and 3 Gy per one fraction will be prescribed on 18 consecutive weekdays. The duration of treatment will be 3 to 4 weeks.

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male

Key inclusion criteria

a) radiotherapy will be selected as adjuvant or salvage therapy after radical prostatectomy at the University of Tokyo Hospital
b) pT3, surgical margin positive, or PSA recurrence after prostatectomy
c) ECOG performance status is 0-2
d) written informed consent is gained

Key exclusion criteria

a) patient refused to participate in this trial
b) distant metastasis is recognized
c) past history of irradiation to pelvis
d) participation in another clinical trial which may affect this trial
e) judged as inappropriate to participation by investigators

Target sample size

55

Name of lead principal investigator

1st name	Hideomi
Middle name
Last name	Yamashita

Organization

The Univesity of Tokyo

Division name

Radiology

Zip code

113-8655

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-3815-5411

Email

yamachan07291973@yahoo.co.jp

Name of contact person

1st name	Hideomi
Middle name
Last name	Yamashita

Organization

The Univesity of Tokyo

Division name

Radiology

Zip code

113-8655

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-3815-5411

Homepage URL

Email

yamachan07291973@yahoo.co.jp

Institute

The University of Tokyo

Institute

Department

Personal name

Organization

The University of Tokyo

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

The University of Tokyo Hospital Institutional Review Board

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan

Tel

03-5841-0818

Email

ethics@m.u-tokyo.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

12

Month

17

Day

URL releasing protocol

not available

Publication of results

Published

URL related to results and publications

https://www.sciencedirect.com/science/article/pii/S0167814026003889?via%3Dihub

Number of participants that the trial has enrolled

55

Results

Between December 2018 and November 2021, 55 patients received protocol treatment. The median follow-up was 37.3 months. Grade 2 or higher acute GU and GI toxicities occurred in 5.5% and 34.5% of patients, respectively; GI events were predominantly grade 2, with one patient (1.8%) experiencing grade 3 small bowel obstruction. The 3-year bRFS was 65.8% (95% confidence interval, 51.1-77.1). QoL was largely maintained, with transient bowel symptoms resolving within three months.

Results date posted

2026

Year

05

Month

07

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

The median age was 72 years (55-88). Forty-nine patients (89.1%) received salvage RT, and six patients (10.9%) received adjuvant RT. ADT was administered concurrently during the RT period in 29 patients (52.7%). Among patients receiving ADT, the median duration of ADT was 6 months (4-36). Four patients (7.3%) had pathologically confirmed lymph node metastasis. The median time from prostatectomy to initiation of RT was 33.7 months (1.9-212.8). The median PSA level prior to RT was 0.32 ng/mL (0.01-2.92), and the median PSA doubling time was 6.2 months (1.5-45.6).

Participant flow

Fifty-six patients were found to be eligible, but one declined to participate in the study. Fifty-five patients were enrolled, and all received the protocol treatment.

Adverse events

The occurrence of grade 2 or higher acute GU and GI toxicity was observed in three (5.5%) and 19 patients (34.5%), respectively. As grade 3 acute toxicity, small bowel obstruction requiring hospitalization and surgical intervention was observed in one patient (1.8%). Grade 2 or higher late GU and GI toxicities were observed in eight (14.6%) and 12 patients (21.8%), respectively. Grade 3 late GU toxicity occurred in three patients (5.5%), whereas no grade 3 late GI toxicity was observed. Grade 4 toxicity was not observed in either the acute or late-onset phases.

Outcome measures

No patients died during the follow-up period. Biochemical recurrence was observed in 16 patients (29.1%). The 3-year bRFS rate was 65.8% (95% CI, 51.1-77.1).

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2018

Year

08

Month

24

Day

Date of IRB

2018

Year

11

Month

22

Day

Anticipated trial start date

2019

Year

01

Month

14

Day

Last follow-up date

2023

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

12

Month

17

Day

Last modified on

2026

Year

05

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038460