Phase II study of additional indication on extreme hypofractionated stereotactic body radiation therapy for prostate cancer

Phase II study of additional indication on extreme hypofractionated stereotactic body radiation therapy for prostate cancer - Phase II study of additional indication on extreme hypofractionated stereotactic body radiation therapy for prostate cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000032423

Enrollment

Registered

2018-05-01

Start date

2018-05-01

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

Extreme hypofractionated stereotactic body radiation therapy

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: (1) Histologically proved prostate adenocarcinoma (2) Low or intermediate or highg risk prostate cancer (T1-T3aN0M0 and PSA=<50 and GS:6-10) (3) 50y.o. =< age =< 80 y.o. (4) ECOG performance status 0-1 (5) Posible to insert fiducial gold markers (6) 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 collagen disease, heart disease, interstitial pneumonia, liver cirrhosis, etc.) (4) Mental diseases which prevent from registration of this trial (5) History of pelvic radiation therapy (6) History of pelvic surgery (7) History of prostate surgery including TUR-P and HIFU (8) History of chemotherapy for prostate cancer (9) Patients with inflammatory bowel disease (10) Patients treated with anticoagulant (11) IPSS => 20 (12) Persons who are judged inappropriate by the researcher

Design outcomes

Primary

Measure	Time frame
Incidence of 5 year chronic adverse events	—

Secondary

Measure	Time frame
Incidence of acute adverse events, Incidence of 5 year biochemical failure free survival, Incidence of 5 year clinical failure free survival, Incidence of 5 year overall survival	—

Countries

Japan

Contacts

Public ContactTakeshi Akiba

Tokai university school of medicine Radiation oncology

takiba@is.icc.u-tokai.ac.jp0463-93-1121

Outcome results

None listed

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