Skip to content

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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000035287
Enrollment
55
Registered
2018-12-17
Start date
2019-01-14
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer

Interventions

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 durat

Sponsors

The University of Tokyo
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactHideomi Yamashita

The Univesity of Tokyo Radiology

yamachan07291973@yahoo.co.jp03-3815-5411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026