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A clinical study on the safety of hypo-fractionated stereotactic intensity-modulated radiation therapy for prostate cancer

A clinical study on the safety of hypo-fractionated stereotactic intensity-modulated radiation therapy for prostate cancer - hypo-fractionated stereotactic intensity-modulated radiation therapy for prostate cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012057
Enrollment
25
Registered
2013-10-17
Start date
2014-02-01
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

Hypo-fractionated stereotactic intensity-modulated radiotherapy (54Gy/15 fractions/3 weeks) is applied after 4 to 8 months neoadjubant hormonal (CAB) therapy.

Sponsors

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

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Histo-pathologically confirmed as adenocarcinoma of the prostate. 2) Prostate cancer cases classified to low-risk or intermediate-risk based on the D'Amico's definition. 3) Age at the registration is >=50 and <80 years old. 4) Performance status is 0 or 1 with Cooperative Oncology Group definition. 5) Cases submitted a written informed consent.

Exclusion criteria

Exclusion criteria: 1) Active double cancer 2) Uncontrolled diabetes mellitus (HbA1c>+8.4%) 3) Severe coexisting diseases such as collagen disease, heart disease, respiratory disease and liver disease. 4) Psychotic disease 5) History of pelvic irradiation 6) History of pelvic surgery except for appendectomy and femoral herniation. 7) Surgical managements to the prostate 8) Chemotherapy to the prostate cancer 9) Inflammatory bowel diseases 10) Cases who are difficult to discontinue the administration of anticoagulant drugs.

Design outcomes

Primary

MeasureTime frame
Incidences of acute adverse events

Secondary

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

Countries

Japan

Contacts

Public ContactTakashi Mizowaki

Kyoto University Graduate School of Medicine Department of Radiotherapy

mizo@kuhp.kyoto-u.ac.jp075-751-3762

Outcome results

None listed

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