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Phase 1/2 clinical trial of image-guided hypofractionated intensity-modulated radiotherapy/volumetric modulated arc therapy for localized low- or intermediate-risk prostate cancer

Phase 1/2 clinical trial of image-guided hypofractionated intensity-modulated radiotherapy/volumetric modulated arc therapy for localized low- or intermediate-risk prostate cancer - Image-guided IMRT/VMAT for localized prostate cancer

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000010295
Enrollment
50
Registered
2013-03-22
Start date
2012-10-23
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

Patients are treated with image-guided hypo fractionated IMRT/VMAT (67.6Gy/26fx.) using fiducial gold markers in the prostate.

Sponsors

Tohoku University
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Prostate adenocarcinoma is proven. 2) Patient should receive MRI examination before treatment. 3) cT1-T2N0M0, Gleason score<or=7, pretreatment PSA <20ng/ml 4) ECOG PS 0-1 5) Patients must sign informed consent form prior to registration

Exclusion criteria

Exclusion criteria: 1) Prior pelvic radiotherapy 2) Small cell carcinoma 3) cT3-4, exist of metastasis 4) Prior prostatectomy 5) Concurrent invasive cancers or collagen disease 6) PSA failure following hormonal therapy 7) If the attending physician judges the case inappropriate. 8) Gold allergy 9) Severe diabetes mellitus 10) Usage of anticoagulants/antiaggregant 11) Biochemical failure after hormonal therapy 12) Difficult to comply with dose constraints 13) IPSS>or=20

Design outcomes

Primary

MeasureTime frame
5-y biochemical relapse free survival

Secondary

MeasureTime frame
5-y distant metastasis free survival 5-y cause-specific survival 5-y overall survival Toxicity (acute and late)

Countries

Japan

Contacts

Public ContactKen Takeda

Tohoku University Hospital Department of Radiation Oncology

ken.takeda.a3@tohoku.ac.jp022-717-7312

Outcome results

None listed

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