Phase I dose-escalation study of stereotactic body radiation therapy for prostate cancer

Phase I dose-escalation study of stereotactic body radiation therapy for prostate cancer - Phase I dose-escalation study of stereotactic body radiation therapy for prostate cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000039444

Enrollment

Registered

2020-02-10

Start date

2020-02-10

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 received five-fraction stereotactic body radiation therapy (SBRT) every other day in weekdays. Total dose was 42.5 Gy, 45 Gy, or 47.5 Gy using 6+6 design. Dose-escalation was independently pe

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: a) Pathologically proven prostate cancer b) ECOG performance status of 0-2 c) Aged 20 to 85 years old at the time of informed consent d) Written informed consent

Exclusion criteria

Exclusion criteria: a) Refusal to participate b) Lymph node or distant metastasis c) History of treatment except hormone therapy for prostate cancer d) History of radiotherapy for pelvic region e) Inflammatory bowel disease like ulcerative colitis and Crohn's disease f) History of surgery for rectal disease g) Participants of other clinical trial that may affect the result of this study h) Ineligible patients judged by investigators Following patients were ineligible for injection of hydrogel spacer i) Difficult to insert the ultrasound probe into the rectum j) Allergic to local anesthetic agents k) Rectum invasion or dorsal extracapsular invasion

Design outcomes

Primary

Measure	Time frame
The incidence of CTCAE grade 3-5 toxicity during the initiation of radiotherapy and 180 days from the end of radiotherapy. Toxicities will be graded using CTCAE version 5.0.	—

Secondary

Measure	Time frame
The incidence of toxicity during the initiation of radiotherapy and 90 days from the end of radiotherapy The incidence of toxicity during the follow-up period after 91 days from the end of radiotherapy The incidence of toxicity caused by injection of hydrogel spacer The incidence of patient-reported toxicity based on PRO-CTCAE version 1.0 Quality of life using EPIC and FACT-P The International Prostate Symptom Score (IPSS) Overall survival biochemical recurrence-free survival using the Phoenix definition of biochemical failure	—

Measure

Time frame

The incidence of toxicity during the initiation of radiotherapy and 90 days from the end of radiotherapy The incidence of toxicity during the follow-up period after 91 days from the end of radiotherapy The incidence of toxicity caused by injection of hydrogel spacer The incidence of patient-reported toxicity based on PRO-CTCAE version 1.0 Quality of life using EPIC and FACT-P The International Prostate Symptom Score (IPSS) Overall survival biochemical recurrence-free survival using the Phoenix definition of biochemical failure

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Countries

Japan

Contacts

Public ContactHideomi Yamashita

The University of Tokyo Hospital Radiology

yamachan07291973@yahoo.co.jp03-3815-5411

Outcome results

None listed

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