Hypofractionated Proton Beam Therapy of 51.6Gy(RBE) in 12 fractions (3 weeks) with real-time-image gated spot-scanning system for non-metastatic prostate cancer (T1c-T4N0M0)

Hypofractionated Proton Beam Therapy of 51.6Gy(RBE) in 12 fractions (3 weeks) with real-time-image gated spot-scanning system for non-metastatic prostate cancer (T1c-T4N0M0) - Hypofractionated Proton Beam Therapy of 51.6Gy(RBE) in 12 fractions (3 weeks) for non-metastatic prostate cancer (T1c-T4N0M0)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000046163

Enrollment

180

Registered

2022-02-01

Start date

2022-01-01

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

Hypofractionated Proton Beam Therapy of 51.6Gy(RBE) in 12 fractions (3 weeks)

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Pathological (histologically) proven diagnosis of prostatic adenocarcinoma. Patients must be between 20 years old and 84 years old. Eastern Cooperative Oncology Group(ECOG) Performance status 0-2. Clinical stage T1c-T4N0M0 (UICC 8th edition) ; absence of metastasis by CT, MRI, bone scan or metabolic images. Other radiation therapy (except for proton beam therapy), surgery or chemotherapy will not be used. Patient must be able to provide study specific informed consent.

Exclusion criteria

Exclusion criteria: Prior radiotherapy to the pelvic area Prior prostate cancer therapy such as: prostatectomy, radiation therapy, chemotherapy or high intensity focused ultrasound (HIFU) . Patients with previous Transurethral Resection of the Prostate (TURP) performed for urinary retention may be included. Second invasive malignancy (except of carcinoma in situ, treated by optimal therapy) if not controlled within last 5 years. It is clinically difficult to place fiducial markers into prostate. There is uncontrollable inflammation in pelvic lesion or inflammatory systemic disease. It is difficult to provide study-specific informed consent prior to study entry.

Design outcomes

Primary

Measure	Time frame
Genitourinary early adverse effects (at and up to 13 weeks: from the start of treatment) Genitourinary late adverse effects (at and up to 5 years: from 13 weeks after the start of treatment)	—

Secondary

Measure	Time frame
Genitourinary late adverse effects (at and up to 2 years: from 13 weeks after the start of treatment) Gastrointestinal early adverse effects (at and up to 13 weeks: from the start of treatment) Gastrointestinal late adverse effects (at and up to 2 years: from 13 weeks after the start of treatment) Gastrointestinal late adverse effects (at and up to 5 years: from 13 weeks after the start of treatment) Freedom from biochemical failure Freedom from biochemical or clinical failure Disease specific survival Overall survival Assessment of the quality of life and sexual function following proton therapy. [ Time Frame: Baseline, Months 3(+/- 0.5), 6(+/- 1.5), 12(+/- 1.5), 24(+/- 2.5), 36(+/- 2.5), 48(+/- 2.5), 60(+/- 2.5) ] EPIC (Expanded Prostate Cancer Index Composite) SF (Short Form Health Survey) -12 Assessment of IPSS (International Prostate Symptom Score) [ Time Frame: Baseline, Weeks 4(+/- 1), 8(+/- 1), Months 3(+/- 0.5), 6(+/- 1.5), 9(+/- 1.5), 12(+/- 1.5), 18(+/- 2.5), 24(+/- 2.5), 30(+/- 2.5), 36(+/- 2.5), 42(+/- 2.5), 48(+/- 2.5), 54(+/- 2.5), 60(+/- 2.5)] Assessment of SHIM (Sexual Health Inventory for Men) [ Time Frame: Baseline, Months 12(+/- 1.5), 24(+/- 2.5), 36(+/- 2.5), 48(+/- 2.5), 60(+/- 2.5) ]	—

Measure

Time frame

Genitourinary late adverse effects (at and up to 2 years: from 13 weeks after the start of treatment) Gastrointestinal early adverse effects (at and up to 13 weeks: from the start of treatment) Gastrointestinal late adverse effects (at and up to 2 years: from 13 weeks after the start of treatment) Gastrointestinal late adverse effects (at and up to 5 years: from 13 weeks after the start of treatment) Freedom from biochemical failure Freedom from biochemical or clinical failure Disease specific survival Overall survival Assessment of the quality of life and sexual function following proton therapy. [ Time Frame: Baseline, Months 3(+/- 0.5), 6(+/- 1.5), 12(+/- 1.5), 24(+/- 2.5), 36(+/- 2.5), 48(+/- 2.5), 60(+/- 2.5) ] EPIC (Expanded Prostate Cancer Index Composite) SF (Short Form Health Survey) -12 Assessment of IPSS (International Prostate Symptom Score) [ Time Frame: Baseline, Weeks 4(+/- 1), 8(+/- 1), Months 3(+/- 0.5), 6(+/- 1.5), 9(+/- 1.5), 12(+/- 1.5), 18(+/- 2.5), 24(+/- 2.5), 30(+/- 2.5), 36(+/- 2.5), 42(+/- 2.5), 48(+/- 2.5), 54(+/- 2.5), 60(+/- 2.5)] Assessment of SHIM (Sexual Health Inventory for Men) [ Time Frame: Baseline, Months 12(+/- 1.5), 24(+/- 2.5), 36(+/- 2.5), 48(+/- 2.5), 60(+/- 2.5) ]

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Countries

Japan

Contacts

Public ContactNorihiro Aibe

Kyoto Prefectural University of Medicine Department of Radiology

a-ib-n24@koto.kpu-m.ac.jp075-251-5620

Outcome results

None listed

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