Phase II study of hypofractionated intensity-modulated radiation therapy using image-guided radiation techniques for prostate cancer

Phase II study of hypofractionated intensity-modulated radiation therapy using image-guided radiation techniques for prostate cancer - Phase II study of hypofractionated radiation therapy for prostate cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007810

Enrollment

130

Registered

2012-07-02

Start date

2012-07-01

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 with 70 Gy delivered at 2.5-Gy/fraction using image-guided radiation techniques

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1) Histologically proved prostate cancer(adenocarcinoma) 2) Low or intermediate risk prostate cancer(T1-T2c and PSA =<20 and G =<7) or high risk cancer with one of high risk factors (T3a, 20< PSA =<30 or G=8,9) 3) 50y.o. <= age < 80 y.o. 4) ECOG performance status 0-1 5))Written informed consent

Exclusion criteria

Exclusion criteria: 1) Cancer patients with a duplication of activity 2) Patients with severe or uncontrollable diabetes 3) Serious medical complications (uncontrollable pulmonary disease, heart disease, kidney disease, liver disease) 4) Mental diseases which prevent from registration of this trial 5) History of pelvic radiation therapy 6) History of abdominal or pelvic surgery 7) History of prostate surgery including HIFU 8) History of chemotherapy for prostate cancer 9) Patients with inflammatory bowel disease 10) Patients treated with anticoagulant 11) IPSS >= 20 12) Risk organs are too close to the PTV to keep dose constraints. 13) Patients with metal artifacts in pelvic CT images.

Design outcomes

Primary

Measure	Time frame
Incidence of late morbidity	—

Secondary

Measure	Time frame
Incidence of acute morbidity, biochemical failure free survival, clinical progression free survival, overall Survival	—

Countries

Japan

Contacts

Public ContactKatsumasa Nakamura

Kyushu University Hospital Department of Radiology

nakam@radiol.med.kyushu-u.ac.jp092-642-5695

Outcome results

None listed

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