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

NCT00534196 | Completed DMC

• 2 other identifiers: CDR0000562726TUSM-BRI-GU-04-01
• Study Type: observational
• Target: 6,927
• Locations: 1 country
• Sites: 31

Brief 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.

Conditions

Prostate Cancer

Keywords

recurrent prostate cancer; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Progression free survival (PFS)

  5 years

• Quality of life

  Baseline, Month 3, 12, 24 and 36

• IPSS score

  Baseline, Month 3, 12, 24 and 36

• Adverse events

  36 months

Study Arms (1)

Group under operation of brachytherapy

Patients with histologically confirmed adenocarcinoma of the prostate and who are planning to undergo brachytherapy with PI (permanent iodine) or combination of PI with other tratement.

Radiation: Permanent iodine-125 (Brachytherapy)

Interventions

Permanent iodine-125 (Brachytherapy) RADIATION

Observational research was conducted by grouping Brachytherapy with/without PI (permanent iodine) seed implantation.

Group under operation of brachytherapy

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in Japan who is histologically confirmed adenocarcinoma of the prostate and planning to undergo treatment with PI or combination of PI with other treatment.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan: lead
• Kurosawa Hospital: collaborator

Study Sites (31)

Fujita Health University

Toyoake, Aichi-ken, 470-11, Japan

Location

Shikoku Cancer Center

Matsuyama, Ehime, 790-0007, Japan

Location

Ehime University Hospital

Tōon, Ehime, 791-0295, Japan

Location

Isesaki Municipal Hospital

Isesaki, Gunma, 872-0817, Japan

Location

Gunma University Graduate School of Medicine

Maebashi, Gunma, 371-8511, Japan

Location

Kurosawa Hospital

Takasaki, Gunma, 370-0852, Japan

Location

Sapporo Medical University

Sapporo, Hokkaido, 060-8556, Japan

Location

Translational Research Informatics Center

Kobe, Hyōgo, 650-0047, Japan

Location

Ibaraki Prefectural Central Hospital

Kasama, Ibaraki, 309-1793, Japan

Location

Kagawa University Hospital

Hiragi, Kagawa-ken, 761-0793, Japan

Location

Osaka University Graduate School of Medicine

Suita, Osaka, 565-0871, Japan

Location

National Hospital Organization - Saitama National Hospital

Wako, Saitama, 351-0102, Japan

Location

Shiga University of Medical Science

Ōtsu, Shiga, 520-21, Japan

Location

Shimane University Hospital

Izumo, Shimane, 693-8501, Japan

Location

University of Fukui Hospital

Fukui, 910-1193, Japan

Location

Hamanomachi Hospital

Fukuoka, 810-8539, Japan

Location

Kyushu University Hospital

Fukuoka, 812-8582, Japan

Location

Gifu University Graduate School of Medicine

Gifu, 500-8705, Japan

Location

Gunma Cancer Center

Gunma, 373-0828, Japan

Location

Kitasato University School of Medicine

Kanagawa, 228-8555, Japan

Location

Kyoto Prefectural University of Medicine

Kyoto, 602-0841, Japan

Location

Nagasaki University Hospital

Nagasaki, 852-8501, Japan

Location

Okayama University Medical School

Okayama, 700-8558, Japan

Location

Saitama Cancer Center

Saitama, 362-0806, Japan

Location

Tokushima University Hospital

Tokushima, 770-8503, Japan

Location

Nippon Medical School

Tokyo, 113-8603, Japan

Location

University of Tokyo Hospital

Tokyo, 113-8655, Japan

Location

Cancer Institute Hospital of Japanese Foundation for Cancer Research

Tokyo, 135-8550, Japan

Location

National Hospital Organization - Tokyo Medical Center

Tokyo, 152-8902, Japan

Location

Keio University School of Medicine

Tokyo, 160-8582, Japan

Location

Tokyo Women's Medical University

Tokyo, 162-8666, Japan

Location

Related Publications (3)

• Ito K, Saito S, Yorozu A, Kojima S, Kikuchi T, Higashide S, Aoki M, Koga H, Satoh T, Ohashi T, Nakamura K, Katayama N, Tanaka N, Nakano M, Shigematsu N, Dokiya T, Fukushima M; J-POPS Investigators. Nationwide Japanese Prostate Cancer Outcome Study of Permanent Iodine-125 Seed Implantation (J-POPS): first analysis on survival. Int J Clin Oncol. 2018 Dec;23(6):1148-1159. doi: 10.1007/s10147-018-1309-0. Epub 2018 Jun 22.

  PMID: 29934842 DERIVED

• Nakano M, Yorozu A, Saito S, Sugawara A, Maruo S, Kojima S, Kikuchi T, Fukushima M, Dokiya T, Yamanaka H. Seed migration after transperineal interstitial prostate brachytherapy by using loose seeds: Japanese prostate cancer outcome study of permanent iodine-125 seed implantation (J-POPS) multi-institutional cohort study. Radiat Oncol. 2015 Nov 14;10:228. doi: 10.1186/s13014-015-0532-3.

  PMID: 26577301 DERIVED

• Saito S, Ito K, Yorozu A, Aoki M, Koga H, Satoh T, Ohashi T, Shigematsu N, Maruo S, Kikuchi T, Kojima S, Dokiya T, Fukushima M, Yamanaka H. Nationwide Japanese Prostate Cancer Outcome Study of Permanent Iodine-125 Seed Implantation (J-POPS). Int J Clin Oncol. 2015 Apr;20(2):375-85. doi: 10.1007/s10147-014-0704-4. Epub 2014 May 21.

  PMID: 24840041 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• Shiro Saito, MD, PhD

  National Hospital Organization Tokyo Medical Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2007
• First Posted: September 24, 2007
• Study Start: July 1, 2005
• Primary Completion: November 30, 2016
• Study Completion: December 13, 2021
• Last Updated: June 26, 2023

Record last verified: 2022-05

Locations

JP (31)