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Completed

NCT Number: NCT00534196

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Observational

Primary location

Fujita Health University, Toyoake, Aichi-ken, Japan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Permanent iodine-125 (Brachytherapy)

Radiation

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

Primary outcomes

  1. PSA relapse-free survival

    Time frame: 5 years

    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.

Secondary outcomes

  1. Progression free survival (PFS)

    Time frame: 5 years

    Dration from enrollment to the date of biochemical relapse or clinical relapse, overall survival (OS), cause-specific survival (CSS).

  2. Quality of life

    Time frame: Baseline, Month 3, 12, 24 and 36

    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.

  3. IPSS score

    Time frame: Baseline, Month 3, 12, 24 and 36

    Evaluated by International Prostate Syndrom Score (IPSS)

  4. Adverse events

    Time frame: 36 months

    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.

Sponsors and collaborators

Lead sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Other

Collaborators

  • Kurosawa Hospital

Registry information

Official study title

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

Acronym: J-POPS

Important dates

Study start
2005
Primary completion
2016
Study completion
2021
First posted
Sep 24, 2007
Registry last updated
Jun 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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