Skip to content

The evaluation of the adverse effects in the prostate cancer patient who received a focal brachytherapy.

The evaluation of the adverse effects in the prostate cancer patient who received a focal brachytherapy. - The evaluation of the adverse effects in the prostate cancer patient who received a focal brachytherapy.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000026453
Enrollment
20
Registered
2017-03-08
Start date
2017-03-09
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 caner

Interventions

Sponsors

Tokyo Metropolitan Police Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Patients must be under these conditions 1) Patients expect to live more than 10 years after the treatment 2) Prostate cancers are diagnosed by biopsies which they receive in our hospital 3) Patients can receive MRI imaging check and the clinical staging before biopsies is T2aN0. 4) PSA was 20.00 ng/ml or less. 5) The computed tomography (CT) of the chest/abdomen/pelvis and bone scintigraphy do not detect metastatic lesions 6) Functions of the main organs are maintained 6-1) Lliver function; AST and ALT is under 3 times the upper limit of the normal range. 6-2) Heart function;there is no severe abnormality in the electrocardiogram or normal it is confirmed that there is no severe abnormalities by the cardiac ultrasound. 6-3) Renal function; estimated GFR is 15 per minute or more. 7) There is no pubic arch interference in the prostate brachytherapy. 8) It is confirmed at least once that a residual volume is 200 ml or less by an ultrasound. 9) The prostate volume is 50 ml or less by the trans rectal ultrasound. 10) We obtain a written Informed consent of the participation of the study. 11) The result of the prostate biopsy was under these conditions 11-1) The biopsy was performed along the parasagittal, peripheral and base areas of the prostate with an interval of 5 mm. The core number of systematic biopsy is 16 or more and MRI/US fusion-guided biopsy was performed. If the volume of the prostate is small ,the base area of the biopsy can be abbreviated. 11-2) The lesions of the cancer detected core are limited in the targeted area by MRI/US fusion biopsy and the surrounding area. 11-3) The lesions of the cancer detected core was limited in the left or right lobe of the prostate. 12) The result of the biopsy meet any of these Gleason scores and the proportion of the cores. 12-1) Gleason score is 3+3 12-2) Gleason score is 3+4 12-3) Gleason score is 4+3 and the proportion of the core is 50 or less.

Exclusion criteria

Exclusion criteria: Patients must not be under these conditions 1) Patients who had past surgical histories of benign prostatic hyperplasia. 2) Patients who had severe mental disorders. 3) Patients who had other active cancers 4) Patients who doctors judge as unsuitable for this study

Design outcomes

Primary

MeasureTime frame
recovery periods from urinary dysfunctions after treatments it is assessed after the treatments by using IPSS, OABSS, IIEF5, FACT-P, NIHCPSI 1 month, 3 months and every 3 months afterwards.

Secondary

MeasureTime frame
sexual function assessed by using IIEF5 rectal bleeding

Countries

Japan

Contacts

Public ContactYuji Hakozaki

Tokyo Metropolitan Police Hospital Department of Urology

yhakozaki11012@gmail.com+81-03-5343-5611

Outcome results

None listed

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