Phase II trial of stereotactic body radiotherapy with a hydrogel spacer for prostate cancer

Phase II trial of stereotactic body radiotherapy with a hydrogel spacer for prostate cancer - Prostate stereotactic body radiotherapy with a hydrogel spacer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026213

Enrollment

Registered

2017-02-20

Start date

2017-02-20

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

Insertion of the hydrogel spacer

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Prostate cancer patients Pathologically diagnosed adenocarcinoma Age >= 20 years, <= 80 years Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) grade 0-2 Number of prostate core needle biopsies >= 8 Patients must provide written, informed consent before any study procedures occur

Exclusion criteria

Exclusion criteria: Patients with lymph node metastasis and or distant metastasis History of prostate cancer treatment (surgery, high intensity focused ultrasound, chemotherapy) Hormone therapy >= 12 months before radiotherapy History of pelvic radiotherapy History of any other malignancy within 2 years (except carcinoma in situ) Severe cardiovascular disease Severe respiratory disease Liver disease (AST, ALT >20 x ULN) Severe kidney disease requiring hemodialysis Unable to provide written informed consent Inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis) History of lowerpelvic surgery Metal in pelvic or near pelvic area (e.g. total hip replacement) affecting pelvic CT scan Bleeding tendency that may disrupt hydrogel spacer insertion (Plt <= 100000, PT INR > 1.5 ULN (with anticoagulant, PT INR > 2.5 ULN), APTT >= 2 x ULN) Unable to insert ultrasound probe (e.g. anal stenosis) Allergic to local anesthetics Considered not appropriate for the study by investigator

Design outcomes

Primary

Measure	Time frame
All acute gastrointestinal toxicity	—

Secondary

Measure	Time frame
Dose Volume Histogram Adverse events related to spacer insertion Success rate of spacer insertion Position of the spacer at the last day of radiotherapy Acute genitourinary toxicity Late gastrointestinal and genitourinary toxicity Other toxicities related to radiotherapy QOL:Expanded Prostate Cancer Index Composite (EPIC) and Functional Assessment of Cancer Therapy Prostate (FACT P) The International Prostate Symptom Score (IPSS) Biochemical failure free survival	—

Measure

Time frame

Dose Volume Histogram Adverse events related to spacer insertion Success rate of spacer insertion Position of the spacer at the last day of radiotherapy Acute genitourinary toxicity Late gastrointestinal and genitourinary toxicity Other toxicities related to radiotherapy QOL:Expanded Prostate Cancer Index Composite (EPIC) and Functional Assessment of Cancer Therapy Prostate (FACT P) The International Prostate Symptom Score (IPSS) Biochemical failure free survival

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Countries

Japan

Contacts

Public ContactMami Ogita

The University of Tokyo Hospital Radiology

ogitam-rad@h.u-tokyo.ac.jp03-3815-5411

Outcome results

None listed

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