Implant Radiation Therapy Using Radioactive Iodine in Treating Patients With Localized Prostate Cancer

Prostate Cancer Clinical Trial

— J-POPS  

Official title:

Japanese Prostate Cancer Outcome Study by Permanent I-125 Seed Implantation [J-POPS]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00534196
• Other study ID #: CDR0000562726
• Secondary ID: TUSM-BRI-GU-04-0
• Status: Completed
• Start date: July 2005
• Est. completion date: December 13, 2021

Study information

• Verified date: May 2022
• Source: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

RATIONALE: Implant radiation therapy delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This clinical trial is studying the side effects and how well implant radiation therapy using radioactive iodine works in treating patients with localized prostate cancer.

Description:

OBJECTIVES:

• To determine the efficacy of permanent brachytherapy with iodine I 125 seeds in patients with localized prostate cancer.

• To determine the safety of this therapy in these patients.

OUTLINE: This is a multicenter study.

Patients undergo permanent brachytherapy seed implantation comprised of iodine I 125 into the prostate. Some patients may receive combination treatment (e.g., external beam radiation therapy (EBRT) or hormone therapy in addition to brachytherapy).

Quality of life and the International Prostate Symptom Score (IPSS) is assessed and compared.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6927
• Est. completion date: December 13, 2021
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

DISEASE CHARACTERISTICS:

• Clinically and histologically confirmed localized prostate cancer

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• No prior or concurrent surgery

• No prior or concurrent radiotherapy

• Prior chemotherapy, hormonal therapy, and biologic therapy allowed

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Permanent iodine-125 (Brachytherapy)
Observational research was conducted by grouping Brachytherapy with/without PI (permanent iodine) seed implantation.

Locations

Country	Name	City	State
Japan	University of Fukui Hospital	Fukui
Japan	Hamanomachi Hospital	Fukuoka
Japan	Kyushu University Hospital	Fukuoka
Japan	Gifu University Graduate School of Medicine	Gifu
Japan	Gunma Cancer Center	Gunma
Japan	Isesaki Municipal Hospital	Isesaki	Gunma
Japan	Shimane University Hospital	Izumo	Shimane
Japan	Kitasato University School of Medicine	Kanagawa
Japan	Ibaraki Prefectural Central Hospital	Kasama	Ibaraki
Japan	Translational Research Informatics Center	Kobe	Hyogo
Japan	Kyoto Prefectural University of Medicine	Kyoto
Japan	Gunma University Graduate School of Medicine	Maebashi	Gunma
Japan	Shikoku Cancer Center	Matsuyama	Ehime
Japan	Kagawa University Hospital	Miki	Kagawa
Japan	Nagasaki University Hospital	Nagasaki
Japan	Okayama University Medical School	Okayama
Japan	Shiga University of Medical Science	Otsu	Shiga
Japan	Saitama Cancer Center	Saitama
Japan	Sapporo Medical University	Sapporo	Hokkaido
Japan	Osaka University Graduate School of Medicine	Suita	Osaka
Japan	Kurosawa Hospital	Takasaki	Gunma
Japan	Tokushima University Hospital	Tokushima
Japan	Cancer Institute Hospital of Japanese Foundation for Cancer Research	Tokyo
Japan	Keio University School of Medicine	Tokyo
Japan	National Hospital Organization - Tokyo Medical Center	Tokyo
Japan	Nippon Medical School	Tokyo
Japan	Tokyo Women's Medical University	Tokyo
Japan	University of Tokyo Hospital	Tokyo
Japan	Ehime University Hospital	Toon	Ehime
Japan	Fujita Health University	Toyoake	Aichi
Japan	National Hospital Organization - Saitama National Hospital	Wako	Saitama

Sponsors (2)

Lead Sponsor	Collaborator
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan	Kurosawa Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSA relapse-free survival	Defined as the duration from enrollment to the date of biological relapse, which was defined as three consecutive prostate specific antigen (PSA) rises in the reflex range of 1.0 ng/ml or greater, and the date of failure was the midpoint between the first day that showed PSA levels 1.0 ng/ml or greater and the last day in which the level was below 1.0 ng/ml.	5 years
Secondary	Progression free survival (PFS)	Dration from enrollment to the date of biochemical relapse or clinical relapse, overall survival (OS), cause-specific survival (CSS).	5 years
Secondary	Quality of life	The Japanese version of the SF-8 (the MOS 8 item Short-Form Health Survey), the Japanese version of the Extended Prostate Cancer Index Composite (EPIC) are used for characterizing Longitudinal changes in health-related quality of life (HRQOL), and the EPIC was used to investigate disease-specific quality of life (disease-specific QOL). Patients enrolled between July 2005 - June 2007 will be evaluated.	Baseline, Month 3, 12, 24 and 36
Secondary	IPSS score	Evaluated by International Prostate Syndrom Score (IPSS)	Baseline, Month 3, 12, 24 and 36
Secondary	Adverse events	Types and severities of adverse events from date of starting protocol treatment until the first 30 months after date of finishing the treatment are evaluated in the most serious adverse events of each reporting period according to Japanese version of the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) by Translational Research Informatics Center.	36 months